Livre»National Eye Institute. Early Treatment Diabetic Retinopathy Study Research Group. NIH publication, no. 81-2192. U.S. Dept. of Commerce, National Technical Information Service. Springfield, Va.
Six hundred sixteen eyes with recent severe diabetic vitreous hemorrhage reducing visual acuity to 5/200 or less for at least one month were randomly assigned to either early vitrectomy or deferral of vitrectomy for one year. After two years of follow-up, 25% of the early vitrectomy group had visual acuity of 10/20 or better compared with 15% in the deferral group (P = .01). In patients with Type I diabetes, who were on the average younger and had more-severe proliferative retinopathy, there was a clear-cut advantage for early vitrectomy, as reflected in the percentage of eyes recovering visual acuity of 10/20 or better (36% vs 12% in the deferral group, P = .0001). No such advantage was found in the Type II diabetes group (16% in the early group vs 18% in the deferral group), but evidence that this advantage differed by diabetes type was of borderline significance.
The Early Treatment Diabetic Retinopathy Study (ETDRS) enrolled 3711 patients with mild-to-severe nonproliferative or early proliferative diabetic retinopathy in both eyes. One eye of each patient was assigned randomly to early photocoagulation and the other to deferral of photocoagulation. Follow-up examinations were scheduled at least every 4 months and photocoagulation was initiated in eyes assigned to deferral as soon as high-risk proliferative retinopathy was detected. Eyes selected for early photocoagulation received one of four different combinations of scatter (panretinal) and focal treatment. This early treatment, compared with deferral of photocoagulation, was associated with a small reduction in the incidence of severe visual loss (visual acuity less than 5/200 at two consecutive visits), but 5-year rates were low in both the early treatment and deferral groups (2.6% and 3.7%, respectively). Adverse effects of scatter photocoagulation on visual acuity and visual field also were observed. These adverse effects were most evident in the months immediately following treatment and were less in eyes assigned to less extensive scatter photocoagulation. Provided careful follow-up can be maintained, scatter photocoagulation is not recommended for eyes with mild or moderate nonproliferative diabetic retinopathy. When retinopathy is more severe, scatter photocoagulation should be considered and usually should not be delayed if the eye has reached the high-risk proliferative stage. The ETDRS results demonstrate that, for eyes with macular edema, focal photocoagulation is effective in reducing the risk of moderate visual loss but that scatter photocoagulation is not. Focal treatment also increases the chance of visual improvement, decreases the frequency of persistent macular edema, and causes only minor visual field losses. Focal treatment should be considered for eyes with macular edema that involves or threatens the center of the macula.
Dans l'étude de la rétinopathie diabétique traitement précoce, un essai clinique randomisé parrainé par le National Eye Institute, un œil de chaque patient a été affecté à la photocoagulation au début et l'autre au report de la photocoagulation (ie, un suivi attentif et l'initiation de la photocoagulation que si haute -Risque rétinopathie proliférante développé). Cette conception a permis l'observation de l'évolution naturelle de la rétinopathie diabétique dans l'œil d'abord traitée. Système de notation de référence photographies du fond d'œil stéréoscopiques d'yeux atteints de rétinopathie non proliférante affecté au report de la photocoagulation ont été utilisés pour examiner la puissance de diverses anomalies et des combinaisons d'anomalies de prédire la progression de la rétinopathie proliférante sur les photos prises lors de la 1, 3 et 5 ans des visites de suivi. Gravité des anomalies intrarétiniennes microvasculaires, des hémorragies et / ou micro-anévrismes, et perles veineuse ont été trouvés être les facteurs les plus importants pour prédire la progression. Sur la base de ces analyses et d'autres considérations, une échelle de gravité de la rétinopathie a été développé. Cette échelle, qui divise la rétinopathie diabétique dans 13 niveaux allant de l'absence de rétinopathie à sévère hémorragie intravitréenne, peut être utilisé pour décrire la gravité globale de la rétinopathie et de changer la gravité au fil du temps.
L'étude traitement précoce rétinopathie diabétique (ETDRS), un essai clinique de collaboration multicentrique soutenu par le National Eye Institute, a été conçue pour évaluer si la photocoagulation au laser à l'argon ou le traitement de l'aspirine peuvent réduire le risque de perte visuelle ou ralentir la progression de la rétinopathie diabétique chez les patients atteints légère à sévère rétinopathie diabétique proliférative non proliférante ou précoce. Les 3711 patients inclus dans l'ETDRS ont été assignés au hasard à l'aspirine (650 mg par jour) ou un placebo. Un œil de chaque patient a été assigné au hasard au début de la photocoagulation au laser à l'argon et l'autre au report de la photocoagulation. Les deux yeux doivent être examinés au moins tous les quatre mois et photocoagulation devait être lancé en yeux affectés au report dès à haut risque de rétinopathie proliférante a été détectée. L'examen d'un grand nombre de caractéristiques oculaires et de patients de référence a indiqué qu'il n'y avait pas de différences importantes entre les groupes de traitement randomisées au départ.
Le traitement de l'aspirine n'a pas modifié le cours de la rétinopathie diabétique chez les patients inscrits dans l'étude traitement précoce rétinopathie diabétique (ETDRS). Dans cet essai clinique randomisé soutenu par le National Eye Institute, 3711 patients atteints de rétinopathie diabétique non proliférante ou au début proliférative légère à sévère ont été assignés au hasard à l'aspirine (650 mg par jour) ou un placebo. L'aspirine n'a pas empêché le développement de risque élevé rétinopathie proliférante et n'a pas réduit le risque de perte visuelle, ni ne augmente le risque d'hémorragie du vitré. Ce était vrai à la fois pour les yeux affectés au hasard au report de la photocoagulation et pour les yeux affectés au hasard au début de l'argon photocoagulation au laser. Les résultats indiquent que pour ETDRS patients avec léger à sévère non-prolifération ou au début de la rétinopathie diabétique proliférante, il est probable que l'aspirine n'a pas d'effet cliniquement bénéfiques importants sur la progression de la rétinopathie. Les données montrent également que l'aspirine 650 mg par jour a eu des effets nocifs cliniquement importants pour les patients diabétiques atteints de rétinopathie. Ces résultats suggèrent qu'il n'y a pas de contre-indication oculaire à l'aspirine en cas de besoin pour les maladies cardiovasculaires ou d'autres indications médicales.
BACKGROUND: The Early Treatment Diabetic Retinopathy Study (ETDRS) enrolled 3711 patients with mild-to-severe nonproliferative or early proliferative diabetic retinopathy in both eyes. Patients were randomly assigned to aspirin 650 mg/day or placebo. One eye of each patient was assigned randomly to early photocoagulation and the other to deferral of photocoagulation. Follow-up examinations were scheduled at least every 4 months, and photocoagulation was initiated in eyes assigned to deferral as soon as high-risk proliferative retinopathy was detected. Aspirin was not found to have an effect on retinopathy progression or rates of vitreous hemorrhage. The risk of a combined end point, severe visual loss or vitrectomy, was low in eyes assigned to deferral (6% at 5 years) and was reduced by early photocoagulation (4% at 5 years). Vitrectomy was carried out in 208 patients during the 9 years of the study. This report presents baseline and previtrectomy characteristics and visual outcome in these patients.
METHODS: Information collected at baseline and during follow-up as part of the ETDRS protocol was supplemented by review of clinic charts for visual acuity and ocular status immediately before vitrectomy.
RESULTS: Vitrectomy was performed in 208 (5.6%) of the 3711 patients (243 eyes) enrolled in the ETDRS. The 5-year vitrectomy rates for eyes grouped by their initial photocoagulation assignment were as follows: 2.1% in the early full scatter photocoagulation group, 2.5% in the early mild scatter group, and 4.0% in the deferral group. The 5-year rates of vitrectomy (in one or both eyes) were 5.4% in patients assigned to aspirin and 5.2% in patients assigned to a placebo. The indications for vitrectomy were either vitreous hemorrhage (53.9%) or retinal detachment with or without vitreous hemorrhage (46.1%). Before vitrectomy, visual acuity was 5/200 or worse in 66.7% of eyes and better than 20/100 in 6.2%. One year after vitrectomy, the visual acuity was 20/100 or better in 47.6% of eyes, including 24.0% with visual acuity of 20/40 or better.
CONCLUSIONS: With frequent follow-up examinations and timely scatter (panretinal) photocoagulation, the 5-year cumulative rate of pars plana vitrectomy in ETDRS patients was 5.3%. Aspirin use did not influence the rate of vitrectomy.
OBJECTIFS: Le présent rapport présente des informations sur les effets de l'aspirine sur la mortalité, la survenue d'événements cardio-vasculaires, et l'incidence de la maladie rénale chez les patients inscrits dans l'étude Early Treatment Diabetic Retinopathy (ETDRS). CONCEPTION D'ÉTUDE: Cette étude multicentrique, randomisée essai clinique de l'aspirine versus placebo a été parrainée par le National Eye Institute. PATIENTS: Les patients (N = 3711) ont été inscrits dans 22 centres cliniques entre avril 1980 et Juillet 1985. Hommes et femmes âgés de 18 à 70 ans avec un diagnostic clinique du diabète sucré ont été admissibles. Environ 30% de tous les patients ont été considérés comme diabète sucré de type I, 31% de type II, et dans 39% de type I ou II ne pouvait pas être déterminé de manière certaine. INTERVENTION: Les patients ont été assignés au hasard à l'aspirine ou un placebo (deux comprimés de 325 mg une fois par jour). PRINCIPALES MESURES DES RÉSULTATS: La mortalité toutes causes confondues a été spécifié que le critère principal de jugement pour évaluer les effets systémiques de l'aspirine. Parmi les autres variables des résultats de mortalité par cause et les événements cardio-vasculaires. RÉSULTATS: L'estimation du risque relatif pour la mortalité totale chez les patients traités par l'aspirine par rapport aux patients traités par placebo pour la période entière de l'étude était de 0,91 (intervalle de confiance à 99%, de 0,75 à 1,11). De plus grandes différences ont été notées pour la survenue d'infarctus du myocarde fatal et non fatal, l'estimation du risque relatif était de 0,83 pour l'ensemble de la période de suivi (99% intervalle de confiance, de 0,66 à 1,04). CONCLUSIONS: Les effets de l'aspirine sur l'un des événements cardiovasculaires pris en compte dans l'ETDRS n'étaient pas sensiblement différents des effets observés dans d'autres études qui comprenait principalement des personnes non diabétiques. En outre, il n'y avait aucune preuve d'effets nocifs de l'aspirine. L'aspirine a été recommandée précédemment pour les personnes à risque de maladie cardiovasculaire. L'application ETDRS soutenir les résultats de la présente recommandation aux personnes atteintes de diabète courent un risque accru de maladie cardiovasculaire.
OBJECTIVE: To determine whether the efficacy of photocoagulation treatment of diabetic macular edema may be influenced by degree of capillary closure, severity or source of fluorescein leakage, extent of retinal edema, presence of cystoid changes, or severity of hard exudates.
PATIENTS: Patients with mild to moderate nonproliferative diabetic retinopathy and macular edema definitely or questionably involving the center of the macula.
DESIGN: One eye of each patient was assigned to early photocoagulation; the other was assigned to deferral of photocoagulation, with follow-up visits scheduled every 4 months and photocoagulation to be carried out promptly if high-risk proliferative retinopathy developed. In this report, the beneficial effect of photocoagulation was examined in subgroups defined by severity of the characteristics specified above.
RESULTS: We found no subgroup in which eyes that were assigned to immediate focal treatment had a less favorable visual acuity outcome than those that were assigned to deferral (ie, no qualitative interaction).
CONCLUSIONS: Focal photocoagulation should be considered for eyes with clinically significant macular edema, particularly when the center of the macula is involved or imminently threatened. Trends for treatment effect to be less in eyes with less extensive retinal thickening and less thickening at the center of the macula support our previous recommendation that, for such eyes, an initial period of close observation may be preferable to immediate treatment, particularly when most of the leakage to be treated arises close to the center of the macula, increasing the risk of damage to it from direct treatment or subsequent migration of treatment scars.
OBJECTIVE: To assess whether the use of aspirin exacerbates the severity or duration of vitreous/preretinal hemorrhages in patients with diabetic retinopathy.
DESIGN: The Early Treatment Diabetic Retinopathy Study (ETDRS), a multicenter randomized clinical trial, was designed to assess the effect of photocoagulation and aspirin on 3711 patients with mild to severe nonproliferative or early proliferative diabetic retinopathy.
INTERVENTION: Patients were randomly assigned to either an aspirin (650 mg/d) or a placebo group. One eye of each patient was randomly assigned to early photocoagulation and the other to deferral of photocoagulation.
MAIN OUTCOME MEASURES: The severity and duration of the vitreous/preretinal hemorrhages were determined from gradings of the annual, seven standard stereoscopic field, fundus photographs. Clinical examinations scheduled every 4 months also provided information on the presence and duration of hemorrhages.
RESULTS: Annual fundus photographs of eyes assigned to deferral of photocoagulation revealed vitreous/preretinal hemorrhages at some time during follow-up in 564 patients (30%) assigned to the placebo group and 585 patients (32%) assigned to the aspirin group (P = .48). Based on gradings of fundus photographs, there were no statistical differences in the severity of vitreous/preretinal hemorrhages (P = .11) or their rate of resolution (P = .86) between the groups. Clinical examination of eyes assigned to deferral of photocoagulation revealed 721 eyes (39%) assigned to the aspirin group and 689 (37%) assigned to the placebo group that had vitreous/preretinal hemorrhages during the course of the study (P = .30). Again, no statistically significant difference was found between the rates of resolution, as assessed clinically, between the two treatment groups (P = .43).
CONCLUSIONS: As previously reported, the use of aspirin did not increase the occurrence of vitreous/preretinal hemorrhages in patients enrolled in the ETDRS. The data presented in this report demonstrate that the severity and duration of these hemorrhages were not significantly affected by the use of aspirin and that there were no ocular contraindications to its use (650 mg/d) in persons with diabetes who require it for treatment of cardiovascular disease or for other medical indications.
OBJECTIVE: To evaluate the relationship between serum lipid levels, retinal hard exudate, and visual acuity in patients with diabetic retinopathy.
DESIGN: Observational data from the Early Treatment Diabetic Retinopathy Study.
PARTICIPANTS: Of the 3711 patients enrolled in the Early Treatment Diabetic Retinopathy Study, the first 2709 enrolled had serum lipid levels measured.
MAIN OUTCOME MEASURES: Baseline fasting serum lipid levels, best-corrected visual acuity, and assessment of retinal thickening and hard exudate from stereoscopic macular photographs.
RESULTS: Patients with elevated total serum cholesterol levels or serum low-density lipoprotein cholesterol levels at baseline were twice as likely to have retinal hard exudates as patients with normal levels. These patients were also at higher risk of developing hard exudate during the course of the study. The risk of losing visual acuity was associated with the extent of hard exudate even after adjusting for the extent of macular edema.
CONCLUSIONS: These data demonstrate that elevated serum lipid levels are associated with an increased risk of retinal hard exudate in persons with diabetic retinopathy. Although retinal hard exudate usually accompanies diabetic macular edema, increasing amounts of exudate appear to be independently associated with an increased risk of visual impairment. Lowering elevated serum lipid levels has been shown to decrease the risk of cardiovascular morbidity. The observational data from the Early Treatment Diabetic Retinopathy Study suggest that lipid lowering may also decrease the risk of hard exudate formation and associated vision loss in patients with diabetic retinopathy. Preservation of vision may be an additional motivating factor for lowering serum lipid levels in persons with diabetic retinopathy and elevated serum lipid levels.
OBJECTIVE: To determine the benefits of early photocoagulation in patients with type I versus type II diabetes.
DESIGN: One eye of each of 3,711 patients was randomly assigned to early photocoagulation; the other was assigned to deferral of photocoagulation, with follow-up visits scheduled every 4 months and photocoagulation to be carried out promptly if high-risk proliferative retinopathy developed. Patients were categorized by age and type of diabetes.
MAIN OUTCOME MEASURES: Best corrected visual acuity was measured at each study visit scheduled at 4-month intervals. Stereoscopic fundus photographs were taken and evaluated at baseline, 4 months, and yearly thereafter. Retinopathy severity was assessed from fundus photographs. Severe visual loss was defined as visual acuity of worse than 5/200 for at least two consecutive study visits.
RESULTS: Previously published results of the Early Treatment Diabetic Retinopathy Study (ETDRS) demonstrated a statistically significant benefit of early photocoagulation in preventing severe vision loss. Further analyses demonstrate that this benefit of early photocoagulation is greater in patients with type II diabetes than in those with type I. The relative benefit of early photocoagulation in patients with type II diabetes is also seen for other outcomes (development of high-risk proliferative retinopathy, development of the combined end point [severe visual loss or vitrectomy], development of moderate visual loss, or development of legal blindness). The patients most likely to benefit from early photocoagulation had severe nonproliferative retinopathy or early proliferative retinopathy. Analyses from the Diabetic Retinopathy Study confirm the relative benefit of scatter photocoagulation for type II patients. Because of the high correlation between age and type of diabetes, analyses sub-grouped by age show similar results.
CONCLUSION: These analyses suggest that patients with type II diabetes, or older patients with diabetes, are more likely to benefit from early scatter photocoagulation than patients with type I diabetes. The current standard of care is to initiate scatter photocoagulation as the severity of retinopathy approaches or reaches the high-risk stage, Provided careful follow-up is possible, ETDRS data do not show that initiating scatter photocoagulation prior to the development of high-risk proliferative diabetic retinopathy in patients with type I diabetes will reduce the risk of severe visual loss. ETDRS analyses do indicate that for patients with type II diabetes, it is especially important to consider scatter photocoagulation at the time of the development of severe nonproliferative or early proliferative retinopathy.
PURPOSE: To identify risk factors for the development of high-risk proliferative diabetic retinopathy (PDR) and for the development of severe visual loss or vitrectomy (SVLV) in eyes assigned to deferral of photocoagulation in the Early Treatment Diabetic Retinopathy Study (ETDRS).
METHODS: Multivariable Cox models were constructed to evaluate the strength and statistical significance of baseline risk factors for development of high-risk PDR and of SVLV.
RESULTS: The baseline characteristics identified as risk factors for high-risk PDR were increased severity of retinopathy, decreased visual acuity (or increased extent of macular edema), higher glycosylated hemoglobin, history of diabetic neuropathy, lower hematocrit, elevated triglycerides, lower serum albumin, and persons with mild to moderate nonproliferative retinopathy, younger age (or type 1 diabetes). The predominant risk factor for development of SVLV was the prior development of high-risk PDR. The only other clearly significant factor was decreased visual acuity at baseline. In the eyes that developed SVLV before high-risk proliferative retinopathy was observed, baseline risk factors were decreased visual acuity (or increased extent of macular edema), older age (or type 2 diabetes), and female gender.
CONCLUSIONS: These analyses supported the view that the retinopathy-inhibiting effect of better glycemic control extends across all ages, both diabetes types, and all stages of retinopathy up to and including the severe nonproliferative and early proliferative stages and the possibility that reducing elevated blood lipids and treating anemia slow the progression of retinopathy.
PURPOSE: To report color vision abnormalities associated with diabetic retinopathy.
METHODS: Color vision function was measured at baseline in 2,701 patients enrolled in the Early Treatment Diabetic Retinopathy Study, a randomized trial investigating photocoagulation and aspirin in the treatment of diabetic retinopathy. Hue discrimination was measured by the Farnsworth-Munsell 100-Hue test, and errors in color vision were reported as the square root of the total 100-Hue (SQRT 100-Hue) score.
RESULTS: Approximately 50% of the Early Treatment Diabetic Retinopathy Study population had color vision scores (SQRT 100-Hue score) worse than 95% of the normal population reported by Verriest and associates. The factors most strongly associated with impaired hue discrimination were macular edema severity, age, and presence of new vessels. A tritan-like defect was prominent and increased in magnitude with increasing severity of macular edema. However, many patients had color discrimination impairment without macular edema.
CONCLUSIONS: Impaired color vision is a common observation among participants enrolled in the Early Treatment Diabetic Retinopathy Study. Compared with published data on normal subjects, approximately 50% of the patients in the Early Treatment Diabetic Retinopathy Study had abnormal hue discrimination. Macular edema severity, age, and the presence of new vessels were the factors most strongly associated with impaired color discrimination. A tritan-like defect was prominent and increased in magnitude with increasing severity of macular edema. Impaired color vision should be considered in the evaluation and counseling of patients with diabetic retinopathy.
PURPOSE: To describe the causes of and risk factors for persistent severe visual loss occurring in the Early Treatment Diabetic Retinopathy Study (ETDRS).
METHODS: The ETDRS was a randomized clinical trial investigating photocoagulation and aspirin in 3,711 persons with mild to severe nonproliferative or early proliferative diabetic retinopathy. Severe visual loss, defined as best-corrected visual acuity of less than 5/200 on at least two consecutive 4-month follow-up visits, developed in 257 eyes (219 persons). Of these 257 eyes, 149 (127 persons) did not recover to 5/200 or better at any visit (persistent severe visual loss). Ocular characteristics of these eyes were compared with those of eyes with severe visual loss that improved to 5/200 or better at any subsequent visit. Characteristics of patients with severe visual loss that did and did not improve and those without severe visual loss were also compared.
RESULTS: Severe visual loss that persisted developed in 149 eyes of 127 persons. In order of decreasing frequency, reasons recorded for persistent visual loss included vitreous or preretinal hemorrhage, macular edema or macular pigmentary changes related to macular edema, macular or retinal detachment, and neovascular glaucoma. Compared with all patients without persistent severe visual loss, patients with persistent severe visual loss had higher mean levels of hemoglobin A1c (10.4% vs 9.7%; P = .001) and higher levels of cholesterol (244.1 vs 228.5 mg/dl; P = .0081) at baseline. Otherwise, patients with persistent severe visual loss were similar to patients with severe visual loss that improved and to those without severe visual loss.
CONCLUSIONS: Persistent severe visual loss was an infrequent occurrence in the ETDRS. Its leading cause was vitreous or preretinal hemorrhage, followed by macular edema or macular pigmentary changes related to macular edema and retinal detachment. The low frequency of persistent severe visual loss in the ETDRS is most likely related to the nearly universal intervention with scatter photocoagulation (either before or soon after high-risk proliferative diabetic retinopathy developed) and the intervention with vitreous surgery when clinically indicated.
OBJECTIVE: To assess the visual results after surgical lens removal in patients with diabetic retinopathy.
DESIGN: A multicenter randomized clinical trial designed to assess the effect of photocoagulation and aspirin in patients with mild to severe nonproliferative or early proliferative diabetic retinopathy and/or macular edema.
PARTICIPANTS: Of the 3711 patients enrolled in the Early Treatment Diabetic Retinopathy Study, lens surgery was performed on 205 patients (270 eyes) during follow-up that ranged from 4 to 9 years.
OUTCOME MEASUREMENTS: Visual acuity, macular edema status, and degree of diabetic retinopathy. In addition, risk factors associated with lens extraction and with poor postoperative visual acuity (worse than 20/100) were assessed.
RESULTS: The risk of lens extraction increased with increasing age, female sex, and baseline proteinuria. Ocular variables associated with increased risk of lens surgery included poor baseline visual acuity and vitrectomy performed during the course of the study. At 1 year after lens surgery, visual acuity improvement of 2 or more lines from preoperative levels occurred in 64.3% of the operated-on eyes assigned to early photocoagulation and 59.3% of eyes assigned to deferral of photocoagulation. In eyes assigned to early photocoagulation, 46% of eyes achieved visual acuity better than 20/40; 73%, better than 20/100; and 8%, 5/200 or worse at 1 year after surgery. Visual acuity results for eyes assigned to deferral of laser photocoagulation at 1 year were not as favorable; 36% achieved visual acuity better than 20/40; 55%, better than 20/100; and 17%, 5/200 or worse at 1 year after surgery. Evaluation of 1-year postoperative visual acuities for all eyes with mild to moderate nonproliferative diabetic retinopathy at the annual visit before lens surgery showed that 53% were better than 20/40; 90%, better than 20/100; and 1%, 5/200 or worse. However, for eyes with severe nonproliferative or worse retinopathy at the annual visit before lens surgery, only 25% were better than 20/40; 42%, better than 20/100; and 22%, 5/200 or worse at 1 year after lens surgery. There was little change in visual acuity between 1 and 2 years postoperatively. Increased severity of retinopathy and poor visual acuity before surgery were associated with visual acuity of worse than 20/100 at 1 year after surgery. Lens surgery was associated with a borderline statistically significant increased risk of progression of diabetic retinopathy in the adjusted analyses (P = .03). No statistically significant long-term increased risk of macular edema was documented after lens surgery.
CONCLUSIONS: Visual acuity results after lens surgery in patients in the Early Treatment Diabetic Retinopathy Study were better than published results for similar patients. This may be because of more intensive photocoagulation for lesions of diabetic retinopathy in the Early Treatment Diabetic Retinopathy Study than in previously reported studies. Although patients with severe nonproliferative retinopathy or worse before lens surgery had poorer visual results, visual improvement was seen in 55% of these patients at 1-year follow-up. The main causes of poor visual results in eyes after lens surgery were complications of proliferative retinopathy and/or macular edema.
OBJECTIVES: To evaluate the long-term natural history and effects of laser photocoagulation treatment in patients with diabetic retinopathy.
DESIGN: Follow-up study of the 214 surviving patients enrolled originally at the Johns Hopkins Clinical Center for the Early Treatment Diabetic Retinopathy Study (ETDRS), which was a clinical trial designed to evaluate the role of laser photocoagulation and aspirin treatment in patients with diabetic retinopathy.
METHODS: Early Treatment Diabetic Retinopathy Study patients enrolled in the Johns Hopkins Clinical Center had complete eye examinations, including best-corrected visual acuity measurements, fundus photographs, and medical questionnaires throughout the 7-year study. They had the same examinations at the final long-term follow-up visit at the National Eye Institute, National Institutes of Health, 13 to 19.5 years after the initial laser photocoagulation (median, 16.7 years).
MAIN OUTCOME MEASURES: The major outcomes were mortality and the rates of moderate and severe vision loss. The secondary outcomes were progression of diabetic retinopathy and need for other eye surgery.
RESULTS: Of the 214 patients who were alive at the end of the original ETDRS in 1989, 130 (61%) were deceased at the time of the re-examination. Of the 84 who were alive, 71 (85%) were examined at their long-term follow-up visit at the National Institutes of Health. At the long-term follow-up examination, 42% had visual acuity of 20/20 or better, and 84% had visual acuity of 20/40 or better in the better eye. Compared with baseline, 20% of patients had moderate vision loss (loss of 3 lines or more vision) in the better eye at follow-up. Only one patient had visual acuity of 20/200 bilaterally. He had visual acuity loss secondary to age-related macular degeneration. No patient had severe vision loss (worse than 5/200). All the initially untreated eyes of patients who had severe nonproliferative diabetic retinopathy or worse by the time of the ETDRS closeout visit of the original study received scatter photocoagulation treatment. Focal photocoagulation was performed in 43% bilaterally and 22% unilaterally. Cataract surgery was performed in 31% of the patients, vitrectomy in 17%, and glaucoma surgery in one patient.
CONCLUSIONS: As previously reported, the mortality rate of patients with diabetic retinopathy is much higher than that of the general population. For those who survived, aggressive follow-up, with treatment when indicated, seems to be associated with maintenance of good long-term visual acuity for most patients. The need for laser scatter photocoagulation with long-term follow-up seems to be high.
PURPOSE: To evaluate the ocular & medical status of patients enrolled in the ETDRS at the Beetham Eye Institute (BEI) of the Joslin Diabetes Center 15 years after the conclusions of the landmark clinical trial. METHODS: ETDRS was a multicenter clinical trial that evaluated laser photocoagulation (PC) in patients with diabetic retinopathy. The current investigation is a single–site, observational, followup study. Patients alive in 2004 were contacted by mail & telephone and respondents received complete eye exam at the BEI, including ETDRS protocol refraction, VA assessment, and 7–field fundus photography. Present health status, diabetes control & medical complications were obtained by standardized questionnaire. Blood pressure, HbA1c, lipid profile & urinalysis were obtained within 3mo of ocular exam. RESULTS: The BEI was the highest enrolling center in the ETDRS accounting for 7% of all patients studied. Of the 232 patients alive at ETDRS conclusion, 94 (41%) were confirmed deceased, 89 (38%) did not respond and 49 (21%) were re–examined as of November 2004 which was 12–17yrs after their final ETDRS visit (median=15yrs). BEI–enrolled patients had mostly type 1 diabetes with 88% evaluated being type 1 vs ∼30% overall in ETDRS. On exam, 9.8% of eyes had > 20/20 VA, 36% > 20/20, 85% > 20/40, 91% > 20/63, 94% > 20/80 and 97% > 20/200. As compared with ETDRS final exam, 16% of eyes had moderate vision loss (>3 lines). Two eyes had severe vision loss (< 5/200, total RD & macular scar). No patient had VA < 20/40 binocularly. All untreated eyes with severe NPDR at conclusions of ETDRS had received scatter PC by the time of followup exam. Post–ETDRS scatter and/or focal PC was performed in 33% of eyes, cataract surgery in 33% and pars plana vitrectomy in 13%. At followup, average SBP & DBP was 131 & 68 mmHg respectively, median HbA1c was 7.8%, and 29% had concurrent nephropathy, neuropathy & cardiovascular disease. Recruitment and assessment of remaining survivors continues. CONCLUSIONS: As previously reported for a group of mostly type 2 diabetes in the ETDRS, mortality rate of this primarily type 1 cohort was high. Concurrent complications were frequent; however, there was long–term maintenance of good VA. Additional PC & cataract extraction was common, suggesting both the benefit and the need for life–long ophthalmic evaluation in patients with diabetic retinopathy.
CONTEXTE: Le traitement par aspirine par jour pendant 5 ans ou plus réduit le risque ultérieur de cancer colorectal. Plusieurs éléments de preuve suggèrent que l'aspirine pourrait également réduire le risque d'autres cancers, en particulier du tractus gastro-intestinal, mais la preuve chez l'homme est dépourvu. Nous avons étudié les décès dus au cancer pendant et après les essais randomisés de l'aspirine tous les jours contre le contrôle fait à l'origine pour la prévention des événements vasculaires.
MÉTHODES: Nous avons utilisé les données individuelles des patients de tous les essais randomisés de l'aspirine tous les jours contre pas l'aspirine avec une durée moyenne de traitement des procès prévu de 4 ans ou plus afin de déterminer l'effet de l'allocation de l'aspirine sur le risque de décès par cancer par rapport à la durée prévue du traitement d'essai pour les cancers gastro-intestinaux et de non-gastro-intestinales. Dans trois grandes études au Royaume-Uni, à long terme après le procès suivi des patients a été obtenue à partir des certificats de décès et les registres du cancer.
RÉSULTATS: Dans huit essais admissibles (25 570 patients, 674 décès par cancer), l'allocation à l'aspirine réduit les décès dus au cancer (odds ratio communs [OR] 0,79, IC à 95% 0,68 -0 · 92, p = 0 · 003). Sur l'analyse des données individuelles des patients, qui étaient disponibles à partir de sept essais (23 535 patients, 657 décès par cancer), avantage était évident qu'après un suivi de 5 années (tous les cancers, risque relatif [RR] 0,66, 0,50 -0 · 87; cancers gastro-intestinaux, 0.46, 0.27 -0 · 77; la fois p = 0,003). Le risque 20 ans de la mort de cancer (1634 décès dans 12 des 659 patients dans trois essais) est restée faible dans les groupes d'aspirine que dans les groupes de contrôle (tous les cancers solides, HR 0,80, 0,72 -0 · 88, p < 0,0001; cancers gastro-intestinaux, 0,65, 0,54 -0 · 78, p <0,0001), et bénéficier augmenté (interaction p = 0,01) avec la durée prévue du traitement d'essai (≥ 7,5 ans: tous les cancers solides, 0,69, 0,54 -0 · 88, p = 0,003; cancers gastro-intestinaux, 0.41, 0.26 -0 · 66, p = 0,0001). La période de latence avant un effet sur la mortalité était d'environ 5 ans de l'oesophage, du pancréas, du cerveau, et le cancer du poumon, mais était plus retardée pour l'estomac, le cancer colorectal et le cancer de la prostate. Pour poumon et le cancer de l'œsophage, de l'avantage a été limitée à des adénocarcinomes, et l'effet global sur le risque 20 ans de la mort de cancer était plus grand pour les adénocarcinomes (HR 0,66, 0,56 -0 · 77, p <0,0001). Prestation n'était pas liée à la dose d'aspirine (75 mg vers le haut), le sexe, ou de fumer, mais augmente avec l'âge, la réduction absolue du risque 20 ans de la mort de cancer atteignant 7,08% (2,42 -11 · 74) à 65 ans ans et plus.
Interprétation: l'aspirine quotidienne réduit les décès dus à plusieurs cancers communs pendant et après les essais. Avantage augmente avec la durée du traitement et était homogène dans les différentes populations étudiées. Ces résultats ont des implications pour les directives sur l'utilisation de l'aspirine et de la compréhension de la carcinogenèse et sa sensibilité à l'intervention de la drogue.
FINANCEMENT: Aucun.
