Estudios primarios relacionados a este tópico

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Estudio primario

No clasificado

Augmenting trabeculectomy in glaucoma with subconjunctival mitomycin C versus subconjunctival 5-fluorouracil: A randomized clinical trial

Autores Mostafaei A
Revista Clinical ophthalmology (Auckland, N.Z.)
Año 2011
Enlaces Pubmed DOI PubMed Central

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Objective: The aim of this study was to compare the efficacy of augmenting trabeculectomy with subconjunctival mitomycin C (TMMC) versus 5-fluorouracil (T5-FU) in lowering intraocular pressure (IOP). Methods: Forty eyes from 40 patients referred to the Nikoukari Ophthalmology University Hospital, Tabriz University of Medical Sciences, Tabriz, Iran, were enrolled in a randomized clinical trial. Patients with high-risk open angle glaucoma were allocated to receive either subconjunctival TMMC or T5-FU. Results: Mean overall preoperative IOP was 30.8 mmHg. Mean preoperative IOPs in the TMMC and T5-FU groups were 31.2 ± 9.8 and 30.6 ± 9.9 mmHg, respectively. Postoperatively, mean IOPs were 11.4.3 ± 4.9 and 13.6 ± 3.9 mmHg, respectively for TMMC and T5-FU groups after 6 months. In spite of some existing descriptive differences in IOP between the groups, statistical tests showed no difference in mean and median IOP. Three cases of hypotonia (IOP, 6 mmHg) and 1 case of epithelial keratitis were detected. Conclusion: TMMC and T5-FU appeared to have similar efficacy in lowering IOP. © 2011 Mostafaei, publisher and licensee Dove Medical Press Ltd.

Estudio primario

No clasificado

Long-term Outcomes of Intraoperative 5-Fluorouracil versus Intraoperative Mitomycin C in Primary Trabeculectomy Surgery

Revista Ophthalmology
Año 2009
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Objective: To compare the long-term efficacy of intraoperative 5-fluorouracil (5-FU) and mitomycin C (MMC) in primary trabeculectomy. Design: Comparative case series and extension of a prospective, randomized controlled trial. Participants: One hundred fifteen eyes of 103 subjects undergoing primary trabeculectomy with either intraoperative 5-FU or MMC. Methods: This study is an extension of a 12-month, prospective, double-masked, randomized trial that previously was reported. Subjects were randomized to receive either intraoperative 5-FU (50 mg/ml for 5 minutes) or MMC (0.2 mg/ml for 2 minutes) during primary trabeculectomy. Follow-up data were collected from patient medical records after informed consent was obtained from the study patient. Attempts were made to contact subjects who had been lost to follow-up, and some consented to reexamination. Main Outcome Measures: The primary measure was Kaplan-Meier survival function, with failure defined as intraocular pressure (IOP) of more than 21 mmHg or less than 6 mmHg on 2 consecutive visits, less than 20% reduction from baseline IOP, loss of light perception vision, or additional glaucoma surgery to lower IOP (except bleb revision). Secondary measures included IOP, number of glaucoma medications, visual acuity, additional surgeries, and number and type of complications. Results: Mean follow up was 53.4±31.4 months (interquartile range, 34-82 months) in the 5-FU group and 45.3±28.0 months (interquartile range, 19-70 months) in the MMC group (P = 0.15, t test). Kaplan-Meier success was 0.83 at 3 years and 0.76 at 5 years in the 5-FU group and 0.79 at 3 years and 0.66 at 5 years in the MMC group (P = 0.18, log-rank test). Bleb leakage was the most common complication in each group and developed in approximately 4% of subjects in each group per year (P = 0.33, log-rank test). Conclusions: There were no significant differences between topical 5-FU and topical MMC in reducing IOP of eyes undergoing primary trabeculectomy. Both antifibrosis agents may contribute to the development of bleb leakage. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. © 2009 American Academy of Ophthalmology.

Estudio primario

No clasificado

Long-term comparison of primary trabeculectomy with 5-fluorouracil versus mitomycin C in West Africa.

Autores Kim HY , Egbert PR , Singh K
Revista Journal of glaucoma
Año 2008
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PURPOSE: To compare the long-term efficacy and safety of intraoperative 5-fluorouracil (5-FU) versus mitomycin-C (MMC) used adjunctively with primary trabeculectomy in a Black West African population. DESIGN: Retrospective comparative study supplemented with cross-sectional follow-up data. METHODS: Review of 68 eyes of 68 Black West African subjects that underwent primary trabeculectomy with the use of intraoperative 5-FU or MMC between January 1, 1988 and January 1, 2002 and had at least 3 years postoperative follow-up. Postoperative outcome measures included intraocular pressure (IOP) control, number of glaucoma medications, visual acuity, and complications. RESULTS: Thirty-eight of sixty-eight eyes received 5-FU and 30 received MMC. Mean postoperative follow-up was 7.5 and 6.5 years in the 5-FU and MMC groups, respectively (P=0.17). A higher proportion of eyes in the MMC group achieved "qualified" (with or without medical therapy) success with varying IOP targets relative to the 5-FU group, but the differences were not statistically significant. "Complete" (without medical therapy) postoperative success was greater in the MMC group with a significantly higher proportion achieving an IOP <21 mm Hg (P=0.02). MMC use was also associated with a lower likelihood of receiving IOP-lowering medications postoperatively (P=0.01). Baseline demographic characteristics, preoperative and postoperative IOP, visual acuity, and complications did not differ significantly between the 2 groups. CONCLUSIONS: Intraoperative MMC use is associated with a lower likelihood of requiring postoperative medications and a greater likelihood of achieving IOP lowering without medications relative to the use of 5-FU in a Black West African population.

Estudio primario

No clasificado

The role of antimetabolites in filtration surgery for neovascular glaucoma: intermediate-term follow-up.

Revista Acta ophthalmologica Scandinavica
Año 2007
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PURPOSE: To compare the intermediate-term efficacy of 5-fluorouracil (5-FU) and Mitomycin C (MMC) as adjunctive antimetabolites in neovascular glaucoma (NVG) filtration surgery. METHODS: Forty consecutive eyes of 40 patients with NVG refractory to medical therapy were randomized to receive antimetabolite-augmented trabeculectomy. Eighteen eyes received postoperative 5-FU (5-FU group) and 22 eyes received intraoperative, low-dose (0.2 mg/ml) MMC for 2 mins (MMC group). The main outcome measure was intraocular pressure (IOP). Surgical success was defined as IOP < 21 mmHg with topical treatment (qualified success) or without topical treatment (complete success). Surgical failure was defined as IOP > or = 21 mmHg, despite postoperative topical treatment, and by postoperative blindness. RESULTS: The mean follow-up period was 35.8 +/- 22.6 months in the 5-FU group and 18.6 +/- 17.2 months in the MMC group. This difference was not significant. Mean IOP decreased from 40.4 +/- 10.3 mmHg to 14.7 +/- 3.4 mmHg (p < 0.0001) in the 5-FU group and from 42 +/- 11.3 mmHg to 22.9 +/- 13.3 mmHg (p = 0.0006) in the MMC group; however, the difference between the 5-FU and MMC groups was not significant at any point. The success rate in the 5-FU group was 55.5% (44.4% complete, 11.1% qualified), compared with 54.5% (9.1% complete, 45.4% qualified) in the MMC group. This difference was not significant. CONCLUSIONS: The percentage of patients who achieved postoperative IOP < 21 mmHg was similar in both groups, although a larger proportion of patients treated with MMC-augmented trabeculectomy required topical treatment in comparison with the 5-FU group.

Estudio primario

No clasificado

Un ensayo aleatorio prospectivo comparando intraoperatoria 5-fluorouracilo versus mitomicina C en la trabeculectomía primaria.

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Revista American journal of ophthalmology
Año 2002
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OBJETIVO: Comparar la seguridad y eficacia de intraoperatoria 5-fluorouracilo (5-FU) o intraoperatoria de mitomicina C (MMC) en los ojos sometidos a trabeculectomía primaria. Diseño: ensayo clínico aleatorizado doble ciego prospectivo. MÉTODOS: Ciento quince ojos de 103 pacientes con presión intraocular no controlada (PIO) a pesar de la terapia médica máxima tolerada o láser fueron randomizados prospectivamente de forma doble ciego a uno de dos grupos de tratamiento en un solo entorno institución. Los ojos de Asunto fueron sometidos a trabeculectomía primaria, ya sea con tópica 5-FU (50 mg / ml durante 5 minutos) o MMC tópica (0,2 mg / ml durante 2 minutos). Las medidas de resultado primarias incluyeron el número de ojos que alcanzan presiones objetivo de 21, 18, 15 y 12 mm Hg a los 6 y 12 meses después de la operación. Las medidas de resultado secundarias incluyeron la PIO, la agudeza visual mejor corregida, las complicaciones y las intervenciones. RESULTADOS: De los 115 ojos, 57 recibieron 5-FU, mientras que 58 recibieron MMC. Un objetivo de la PIO de 21 mm Hg a los 6 meses se logró en 53 de 56 (95%) ojos en el grupo de 5-FU y 54 de 57 (95%) ojos en el grupo de MMC (P = 1,00). A los 12 meses, 45 de 48 (94%) ojos en el grupo de 5-FU cumplen un objetivo PIO de 21 mm Hg, mientras que 48 de 54 (89%) ojos en el grupo MMC hicieron (P = 0,49). Las complicaciones más comunes en cada grupo eran efusiones coroideas persistentes y fugas ampolla. CONCLUSIÓN: Nuestro estudio sugiere que intraoperatoria tópica 5-FU es al menos tan eficaz como la MMC intraoperatoria tópica en la reducción de la PIO de los ojos sometidos a trabeculectomía primaria.

Estudio primario

No clasificado

Application of mitomycin C and 5-Fluorouracil in the glaucoma filtering surgery.

Autores Xinyu C , Xiaoning L , Denglei W
Revista Chinese Ophthalmic Research
Año 2001

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Estudio primario

No clasificado

La trabeculectomía con mitomicina C intraoperatoria versus 5-fluorouracilo. Ensayo clínico aleatorizado prospectivo.

automatic
Revista Ophthalmology
Año 2000
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OBJETIVO: Evaluar la eficacia y la seguridad relativa de 5-fluorouracilo (5-FU) y mitomicina C (MMC) cuando se utiliza como complemento con trabeculectomía primaria en los ojos que no tienen alto riesgo de fracaso. DISEÑO: Estudio prospectivo multicéntrico, ensayo clínico aleatorizado. PARTICIPANTES: Ciento trece pacientes con primario de ángulo abierto, pseudoexfoliativo, pigmentaria o glaucoma de ángulo cerrado, programados para trabeculectomía primaria fueron reclutados. MÉTODOS: Un ojo de cada paciente fue aleatorizados para recibir 5-FU (50 mg / ml durante 5 minutos) o MMC (0,4 mg / ml durante 2 minutos). Principales medidas de resultado de la presión intraocular (PIO), la agudeza visual, complicaciones e intervenciones fueron documentados a intervalos fijos después de la cirugía. El estudio también examinó la progresión de la pérdida del campo visual, las complicaciones a largo plazo, y la apariencia de la ampolla 3 años después de la cirugía. RESULTADOS: De los 108 pacientes con información perioperatoria completa, 54 ojos recibieron 5-FU y 54 recibieron MMC. La proporción de pacientes que alcanzan diferentes IOP objetivo predefinidos después de la cirugía fue ligeramente superior en el grupo de MMC que en el grupo 5-FU. Esta diferencia fue menos de 25%, lo que hubiera sido necesario para alcanzar significación estadística con una potencia de 0,8 y el tamaño de muestra utilizado. Del mismo modo, no hubo diferencia estadísticamente significativa entre los grupos con respecto a la media preoperatoria de la PIO, complicaciones o intervenciones. Seguimiento postoperatorio medio fue de 309 y 330 días en el 5-FU y grupos MMC, respectivamente (P = 0,593). CONCLUSIONES: 5-fluorouracilo y MMC se encontraron a ser complementos igualmente seguros y eficaces a trabeculectomía primaria en los períodos postoperatorios a corto y mediano plazo.

Estudio primario

No clasificado

Comparison of low-dose intraoperative mitomycin-C vs 5-fluorouracil in primary glaucoma surgery: a pilot study.

Revista Ophthalmic surgery and lasers
Año 2000
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BACKGROUND AND OBJECTIVE: This study was undertaken to compare the efficacy and safety of low-dose intraoperative application of mitomycin-C (MMC) with that of 5-fluorouracil (5-FU) in primary trabeculectomy. PATIENTS AND METHODS: A non-randomized prospective study was performed between August 1994 and November 1995. Thirty-two eyes of 16 consecutive patients who underwent trabeculectomy for uncontrolled glaucoma of various causes form the study group. The mean age was 46.8 +/- 9.9 years. The first eye received MMC (0.2, 0.4 mg/ml), fellow eye received 5-FU (50 mg/ml), for 1 minute intraoperatively. Bleb characteristics and intraocular pressure (IOP) control were analyzed. Success of surgery based on IOP control was measured by 3 different criteria: IOP less than 21 mm Hg; IOP less than 21 mm Hg with more than 30% reduction; and IOP less than 16 mm Hg with more than 30% reduction. RESULTS: Mean preoperative IOP was 31.4 +/-12.7 mm Hg in MMC group and 27.8+/- 8.8 mm Hg in 5-FU group. Mean follow-up in MMC group was 16.12 +/- 8.17 months; in 5-FU group 13.37 +/- 8.19 months. At last follow-up all 5-FU blebs were nonischemic, while 4 eyes in the MMC group showed nonischemic blebs, and 12 eyes had ischemic blebs. There was no statistically significant difference between MMC group and 5-FU group success rates with all 3 criteria. Success rates were: IOP less than 21 mm Hg; 100% in both groups; IOP less than 21 mm Hg with more than 30% reduction; MMC group 93.8%, 5-FU group 75%; less than 16 mm Hg with more than 30% reduction; MMC group 87.5%, 5-FU group 68.8%. CONCLUSIONS: Low-dose intraoperative MMC and 5-FU can provide control of IOP in primary trabeculectomy, 5-FU group showed more non-ischemic blebs.

Estudio primario

No clasificado

Comparison of phacotrabeculectomy with 5-fluorouracil, mitomycin-C, and without antifibrotic agents.

Revista Ophthalmic surgery and lasers
Año 1999
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BACKGROUND AND OBJECTIVE: To evaluate the potential benefits, complications, and prognostic risk factors for failure of phacotrabeculectomy performed with or without 5-fluorouracil (5-FU) and mitomycin-C (MMC). PATIENTS AND METHODS: Retrospective chart review of 78 patients who underwent phacotrabeculectomy during a 2-year period. Patients were divided into 3 groups, those who received 5-FU (N = 28). MMC (N = 29), or no antifibrotic agent (N = 21). RESULTS: All 3 groups had statistically significant lower intraocular pressures (IOP) on fewer antiglaucomatous medications at 6-month, 12-month, and last follow-up compared to preoperative levels (P < .05). Intraocular pressures were lower in the group that received MMC compared to the 5-FU group, but not in the group that did not receive antimetabolites, at all time intervals measured (P < .05). Black race was a strong predictor of failure of trabeculectomy (P = 009). No differences in final visual acuity or complications were found between groups. CONCLUSIONS: Phacotrabeculectomy is effective regardless of antimetabolite use. Race is a strong predictor of failure.

Estudio primario

No clasificado

Risk of hypotony after primary trabeculectomy with antifibrotic agents in a black west African population.

Autores Singh K , Byrd S , Egbert PR , Budenz D
Revista Journal of glaucoma
Año 1998
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Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia) 1 Resúmenes estructurados de estudios primarios Resúmenes estructurados de estudios primarios (1 referencia)

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PURPOSE: To evaluate the risk of hypotony and hypotony maculopathy following trabeculectomy with 5-fluorouracil (5-FU) and mitomycin C (MMC) in a black West African population. METHODS: One hundred and one eyes of black Ghanaian patients with advanced primary open-angle glaucoma received intraoperative antifibrotic therapy with trabeculectomy as part of two randomized clinical trials. Overall, 57 patients received 5-FU (50.0 mg/ml for 5 minutes) and 44 received MMC (0.5 mg/ml for 3.5 minutes). All cases were performed by one of five surgeons at a single outpatient surgery center. RESULTS: Two of 101 eyes had a final intraocular pressure (IOP) of less than 5 mm Hg and were thus classified as having hypotony. No patient in either group was noted to develop hypotony-related maculopathy. Overall mean pre- and postoperative IOPs were 30.1 and 15.9 mm Hg, respectively. The patients receiving intraoperative MMC had a lower mean postoperative IOP (14.7 mm Hg) than those receiving 5-FU (first study, 17.1 mm Hg; second study, 16.7 mm Hg; p = 0.05). Mean overall follow-up was 17.7 months and did not differ significantly between the MMC and combined 5-FU groups. CONCLUSION: Hypotony following trabeculectomy supplemented with antifibrotic agents is a rare complication in this population. No eyes in either clinical trial developed hypotony maculopathy, suggesting that the prevalence of this condition is substantially lower in black West Africans than in whites.