PURPOSE: To evaluate the efficacy and safety of using Mitomycin-C (MMC) or Ologen implant as an adjunct to combined trabeculotomy-trabeculectomy (CTT) surgery relative to non-augmented CTT surgery in achieving higher success rates in patients with primary congenital glaucoma (PCG).
STUDY DESIGN: A prospective triple-armed randomized controlled clinical trial was conducted in the period between April 2019 and May 2021, targeting 75 eyes of patients with PCG over one year, with patients being followed up for at least one whole year.
PATIENTS AND METHODS: The study included 75 eyes; only 70 fulfilled the inclusion criteria and were randomly assigned to one of the three study groups using a computer program to generate random number list. Eyes were treated by either CTT without augmentation, CTT augmented with MMC, or CTT augmented with Ologen implant. Only 63 eyes completed one year of follow-up and were evenly distributed among the three study groups; with 21 eyes in each group were statistically analyzed.
OUTCOME MEASURES: Our primary outcome measure is to report and compare the percentage of patients who demonstrated complete success with intraocular pressure (IOP) controlled and maintained below 21 mmHg without the use of antiglaucoma medications or additional glaucoma surgery over a one-year follow-up. Secondary outcome measures include reporting failure, intra- and postoperative complications of the three surgical modalities, postoperative corneal diameter, clearance of corneal edema, and postoperative cup/disk (C/D) ratio.
RESULTS: Complete success was achieved in 17 eyes (81.0%) in CTT group, 18 eyes (85.7%) in MMC group, and 17 eyes (81.0%) in Ologen group. Qualified success (IOP < 21 with or without antiglaucoma medications) was achieved in 18 eyes (85.7%) in both the CTT and the Ologen groups, with 19 eyes (90.5%) in the MMC group. Failure was observed in three eyes (14.3%) in both CTT and Ologen groups and two eyes (9.5%) in the MMC group. Based on survival analysis, CTT group had a cumulative success probability of 95.2% at three months, which dropped to 85.7% at six months and remained at that level for the 9th and 12th months of follow-up. With respect to the MMC group, the cumulative success probability at three months was 95.2%, dropped to 90.5% at six months, and remained at that level for the 9th and 12th months of follow-up. While in the Ologen group, the cumulative success probability at three months was 85.7% and remained at the same level during the 6th, 9th, and 12th months of follow-up, with p value = 0.862 using the logrank test.
CONCLUSION: CTT is a safe and effective primary surgical intervention in patients with PCG without the need for augmentation while preserving the augmented procedure's use for recurrent cases.
OBJECTIVE: The aim was to assess the influence of corneal biomechanics on intraocular pressure (IOP) measurements made with the Icare200 (IC200) rebound tonometer and the Perkins handheld applanation tonometer in patients with primary congenital glaucoma (PCG).
MATERIALS AND METHODS: A total of 40 PCG patients and 40 healthy controls, age, and sex-matched, were recruited. IOP was measured with the Ocular Response Analyzer (IOPc, IOPg), IC200 and Perkins. The variables age, IOP, corneal hysteresis (CH), corneal resistance factor (CRF), central corneal thickness (CCT), best-corrected visual acuity, spherical equivalent, medications, and glaucoma surgeries were recorded for each subject. Univariate and multivariate analysis were used to detect effects of variables on IOP measurements.
RESULTS: Mean CCT was 545.65±71.88 μm in PCG versus 558.78±27.58 μm in controls (P=0.284). CH and CRF were significantly lower in PCG group than in control group: mean CH 8.11±1.69 versus 11.15±1.63 mm Hg (P<0.001), and mean CRF 9.27±2.35 versus 10.71±1.75 mm Hg (P=0.002). Mean differences between IOP IC200-Perkins were 0.79±0.53 mm Hg in PCG versus 0.80±0.23 mm Hg in controls (P<0.001) and mean differences IC200-IOPc were -0.89±5.15 mm Hg in PCG (P<0.001) versus 1.60±3.03 mm Hg in controls (all P<0.009). Through multivariate analysis, CRF showed positive association and CH negative association with IOP measured with Perkins or IC200 in both subject groups. No association was detected for CCT, age, or sex.
CONCLUSION: CH and CRF were identified as the main factors interfering with IOP measurements made with both tonometers in patients with PCG and healthy controls.
PURPOSE: To compare outcomes of Ologen augmentation of Ahmed glaucoma valve implantation (AVG) and AGV implantation alone in children operated on for uncontrolled glaucoma.
METHODS: A prospective study was conducted on 33 eyes (18 right eyes) of 33 children (20 males) operated on following failed initial glaucoma surgeries. Eyes were randomized to the AGV or the AGV-Ologen group. The primary outcome was reduction in IOP on 2 years' follow-up in each group. Success was defined as final intraocular pressure (IOP) of 6-20 mm Hg without vision-threatening complications, additional glaucoma operations, or other signs of glaucoma progression.
RESULTS: Mean patient age (range; median) in the AGV-Ologen and AGV groups was 6.5 ± 2.1 years (2.5-10; 6.5) and 6.5 ± 1.9 years (3-9.5; 7), respectively (P = 0.897). Mean follow-up was 42.1 ± 13.7 months (25-64, 41) and 43.3 ± 11.4 (27-62, 42), respectively (P = 0.788). The most common glaucoma diagnosis in each group was primary congenital glaucoma (82.4% and 81.2% resp.). There was significant postoperative reduction in IOP and the number of IOP-lowering medications at 24 months' follow-up (P < 0.0001 and P = 0.002 for AGV-Ologen and AGV, resp.). The AGV-Ologen group demonstrated statistically significantly lower IOP values at all time points than the AGV group. At 24 months, the probability of total success was 77% in AGV-Ologen and 63% in AGV (P = 0.46).
CONCLUSIONS: In our study cohort, AGV implantation was an effective treatment for operated uncontrolled childhood glaucoma for at least 2 years, with Ologen augmentation providing a clear advantage in terms of IOP control, without compromising safety.
PURPOSE: The aim of the study was to compare the effect of viscotrabeculotomy and the effect of trabeculectomy on the intraocular pressure (IOP) in cases of open angle glaucoma (OAG).
STUDY DESIGN: Prospective comparative study.
PATIENTS AND METHODS: The study was conducted on 148 eyes of 148 patients (87 men) presenting with and operated upon for OAG at Mansoura Ophthalmic center of Mansoura University in Mansoura, Egypt from 2012 to 2016. Patients were randomized into viscotrabeculotomy and trabeculectomy groups. Postoperative follow up visits were scheduled at weeks 1 and 2 then months 1, 2, 3, 6, 9, 12, 15, 18, 21 and 24. Complications were noted and managed according to needs. The primary outcome measure was IOP.
RESULTS: The study was conducted on 148 eyes (74 right) of 148 patients (87 men). The mean ± SD (range, median) age of the study patients was 50.1 ± 11.5 (20-67, 53) and 51.1 ± 10.0 (27-65, 54.5) years respectively. The mean ± SD (range, median) IOP of the study eyes on maximal tolerated IOP lowering therapy was 23.15 ± 2.31 (19-30, 23.0) and 23.64 ± 1.87 (20-28, 23.0) mmHg respectively and at the end of the 24 months of follow up was 14.91 ± 2.4 (12-23, 14) and 16.64 ± 2.8 (14-25, 16) mmHg respectively (p = < 0.0005). Notable complications included a mild hyphema in the viscotrabeculotomy group and an IOP spike in the trabeculectomy group.
CONCLUSIONS: Viscotrabeculotomy and trabeculectomy showed efficacy and safety in OAG patients. The former resulted in better IOP reduction.
Background and Aims: Accurate measurement of intraocular pressure (IOP) under anaesthesia is essential for diagnosis and further management of pediatric glaucoma patients. However, depth of anaesthesia and use of airway device like laryngeal mask airway (LMA) or endotracheal tube can influence IOP values measured. We planned this study to compare change of IOP with facemask or LMA. Change of IOP at varying depth of anaesthesia was also assessed. Material and Methods: After Institutional ethical clearance and informed parental consent, 89 children of glaucoma aged 0-12 years were included in this prospective randomized controlled trial. The children were randomized to facemask (Group M) and LMA (Group L). Sevoflurane was the sole general anaesthetic used in both the groups and IOP were recorded after induction, at BIS 40-60, after LMA insertion (Group L), at BIS 60-80 and BIS more than 80. Results: The IOP values did not differ significantly between the groups at BIS 40-60 and at BIS 60-80. Moreover, pre and post LMA insertion IOP values were also comparable in Gr L (p = 0.11). However, significant increase in IOP values were observed with increasing BIS values within each group. The mean IOP in Group M at BIS 40-60 was 13.41 ± 4.04 as compared to 14.18 ± 3.64 at BIS 60-80 (p = 0.003). There was a similar pattern observed in Group L, where mean IOP at BIS 40-60 & BIS 60-80 was 14.13 ± 4.90 and 15.52 ± 4.57 respectively (p < 0.001). Conclusion: Either facemask or classic LMA can be safely used as per anaesthesiologist's preference without any significant effect on IOP. BIS monitoring may be used during IOP measurement in paediatric glaucoma suspects for accurate assessment of IOP.
Introduction: To compare the safety and efficacy of trabeculectomy augmented by subconjunctival application of mitomycin C (MMC) vs combined subconjunctival and subscleral flap MMC application in primary congenital glaucoma (PCG). Methods: This prospective, randomized, interventional study included children aged ≤6 years, requiring a trabeculectomy for PCG. Fifty eyes were randomly assigned to undergo trabeculectomy with subconjunctival MMC application (group A, 25 eyes), or trabeculectomy with combined subconjunctival and subscleral flap MMC application (group B, 25 eyes). Success was defined as achieving an intraocular pressure (IOP) ≤18 mm Hg at 12 months, without medications (complete success) or with/without antiglaucoma medications (qualified success). Postoperative results were compared at 1, 3, 6, 9, 12 months, and the final follow-up. The main outcome measures were IOP, number of glaucoma medications, surgical success, postoperative interventions, and complications in both groups. Results: At 12 months, the percent IOP reduction for group A was 45.6% and for group B 46.8%. Qualified success was achieved in 68% and 72% of eyes in groups A and B, respectively. Failure tended to occur earlier in group B. Kaplan-Meier analysis for complete success showed cumulative probability of survival of 53% for group A and 40% for group B (P = 0.38). Needling was more successful in group B with 60 % total success compared to 33.3% in group A (P value = 0.39). Conclusion/relevance: The subscleral flap application of MMC in conjunction with subconjunctival MMC application in pediatric trabeculectomy does not appear to result in additional benefit regarding safety or efficacy, when compared to subconjunctival application alone.
Introduction: Management of primary congenital glaucoma (PCG) is challenging. Kahook dual blade (KDB) removes a strip of the trabecular meshwork which could make it superior to simple goniotomy in treating the angle anomaly. This study compares KDB ab interno trabeculectomy to conventional goniotomy in PCG. Methods: A total of 42 eyes with PCG were randomized to undergo ab-interno trabeculectomy using the KDB or goniotomy using a 25-gauge irrigating needle, targeting 120°-140° of the nasal iridocorneal angle. Patients were seen at 1, 3, 6 and 12 months. Success was defined as IOP ≤21 mm Hg at final follow-up, with no evidence of glaucoma progression or need further surgery. Results: KDB group included 21 eyes, with a median age of 6 months; the goniotomy group included 21 eyes, with a median age of 5 months at time of surgery. There was a significant reduction in IOP in both groups at all follow-up visits. The reduction in number of glaucoma medications was significant at 1, 3, and 6 months postoperatively in the KDB group, and at 1 month in the goniotomy group.There was no significant difference in IOP or glaucoma medications between both groups at any follow-up visit. Success was achieved in 12 eyes (57.1%) in each group, with no eyes developing any serious complications. Conclusion/relevance: There was a significant reduction in IOP in both groups but no significant difference between both groups in IOP, glaucoma medications or success rates at final follow-up. One-year follow-up shows that KDB is at least as effective as goniotomy in the treatment of PCG.
PRECIS: This study evaluated 2 doses of intranasal dexmedetomidine (IND) (3.0 and 3.5 µg/kg) as a procedural sedative for postoperative examination of children with glaucoma. A dose of 3.5 µg/kg was more efficacious and obviated the need for repeated general anesthesia.
PURPOSE: This study was carried out to determine the safety and effective dose of IND as a procedural sedative for postoperative follow-up examinations after glaucoma surgery in children in place of repeated examination under anesthesia.
MATERIALS AND METHODS: In this prospective randomized double-blinded interventional study, consecutive children aged 6 months to 6 years were randomized to receive 3.0 and 3.5 µg/kg IND using a mucosal atomizer device in the preoperative area of the operating room, under continuous monitoring of vital signs. Intranasal midazolam 0.25 mg/kg was used as a rescue agent in case of inadequate sedation, and general anesthesia was administered in case of persistent failure. All infants underwent a complete anterior and posterior segment evaluation including intraocular pressure and corneal diameter measurements.
RESULTS: A total of 30 and 31 children aged 23.9±15.0 and 19.2±10.1 months, respectively, received 3.0 and 3.5 µg/kg IND. Adequate sedation was possible in 18 of 30 (60%) children receiving 3.0 µg/kg and 24 of 31 (77.4%) receiving 3.5 µg/kg IND alone (P=0.17). In combination with midazolam, successful sedations were 86.6% versus 100%, respectively (P=0.052). One patient in the 3.5 µg/kg group had ventricular arrhythmia, reversed with dextrose-saline infusion and injection glycopyrrolate.
CONCLUSIONS: IND appears to be a safe and effective procedural sedative for postoperative follow-up examinations of pediatric glaucoma patients at doses of 3 and 3.5 µg/kg. The dose of 3.5 µg/kg was successful in more children.
INTRODUCTION: Trabeculotomy and combined trabeculotomy-trabeculectomy (CTT) are major surgical options for primary congenital glaucoma (PCG). However, it is unclear which of these two surgical procedures should be recommended as the optimum first-line treatment for PCG. This trial aims to determine whether the outcomes of trabeculotomy are non-inferior to those of CTT in moderate PCG with a horizontal corneal diameter (HCD) of 12-14 mm.
METHODS AND ANALYSIS: This is a 3-year, non-inferiority, prospective, randomised controlled trial. We plan to recruite 248 participants (aged ≤3 years) with PCG with an HCD of 12-14 mm from the Department of Glaucoma, Zhongshan Ophthalmic Center, Guangzhou, China. One eye per participant will be randomly (1:1) assigned to receive trabeculotomy or CTT. The primary outcome is the 3-year postoperative success rate in lowering intraocular pressure (IOP), and the secondary clinical outcomes will include IOP reduction, visual acuity, HCD, central corneal thickness, axial length, cup-disc ratio, refractive error and postoperative complications. Data will be analysed by the intention-to-treat principle.
ETHICAL APPROVAL AND DISSEMINATION: The study protocol has been approved by the ethics committee of Zhongshan Ophthalmic Center (2014MEKY023) and the '5010 Plan' evaluation committee at Sun Yat-Sen University, Guangzhou, China. The results will be disseminated in international academic meetings and published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: Chinese Clinical Trial Registry, ChiCTR-IOR-14005588; Date registered: 20 November 2014.
PURPOSE: To investigate the role of early and prolonged administration of aqueous suppressants in reduction of hyperencapsulation and intraocular pressure (IOP) control after paediatric Ahmed glaucoma valve (AGV) implantation.
METHODS: A prospective randomized interventional study recruited children who had AGV implantation for paediatric glaucoma. All patients received postoperative Timolol 0.5% for either 12 months (Group A) or 3 months (Group B). Additional IOP-reducing medications were added if IOP exceeded 21 mmHg or hyperencapsulation developed in either group. Primary outcome measures were rate of hyperencapsulation and reduction of IOP.
RESULTS: Eighty sex children completed the 12-month follow-up visits. Baseline IOP was significantly reduced from 31.95 ± 9.1 to 16.94 ± 3.4 mmHg at 12 months in Group A and from 32.7 ± 7.4 to 19.85 ± 6.9 mmHg at 12 months in Group B. IOP was significantly lower in Group A than B at 6-, 9- and 12-month follow-up visits. In the first 4 months, the hyperencapsulation rate was similar in both Group A (six eyes, 13.3%) and Group B (seven eyes, 17.1%). However, the hyperencapsulation rate was significantly lower in Group A than B at both 6 months (22.5% versus 36.6%) and 12 months (31.1% versus 46.3%). Anti-glaucoma medications were significantly lower in Group A than B at both 6 months (1.3 versus 3.2 drugs) and 12 months (1.5 versus 3.6 drugs).
CONCLUSION: Early and prolonged use of aqueous suppressants significantly reduced the rate of hyperencapsulation and provided better IOP control after paediatric AGV implantation.
To evaluate the efficacy and safety of using Mitomycin-C (MMC) or Ologen implant as an adjunct to combined trabeculotomy-trabeculectomy (CTT) surgery relative to non-augmented CTT surgery in achieving higher success rates in patients with primary congenital glaucoma (PCG).
STUDY DESIGN:
A prospective triple-armed randomized controlled clinical trial was conducted in the period between April 2019 and May 2021, targeting 75 eyes of patients with PCG over one year, with patients being followed up for at least one whole year.
PATIENTS AND METHODS:
The study included 75 eyes; only 70 fulfilled the inclusion criteria and were randomly assigned to one of the three study groups using a computer program to generate random number list. Eyes were treated by either CTT without augmentation, CTT augmented with MMC, or CTT augmented with Ologen implant. Only 63 eyes completed one year of follow-up and were evenly distributed among the three study groups; with 21 eyes in each group were statistically analyzed.
OUTCOME MEASURES:
Our primary outcome measure is to report and compare the percentage of patients who demonstrated complete success with intraocular pressure (IOP) controlled and maintained below 21 mmHg without the use of antiglaucoma medications or additional glaucoma surgery over a one-year follow-up. Secondary outcome measures include reporting failure, intra- and postoperative complications of the three surgical modalities, postoperative corneal diameter, clearance of corneal edema, and postoperative cup/disk (C/D) ratio.
RESULTS:
Complete success was achieved in 17 eyes (81.0%) in CTT group, 18 eyes (85.7%) in MMC group, and 17 eyes (81.0%) in Ologen group. Qualified success (IOP < 21 with or without antiglaucoma medications) was achieved in 18 eyes (85.7%) in both the CTT and the Ologen groups, with 19 eyes (90.5%) in the MMC group. Failure was observed in three eyes (14.3%) in both CTT and Ologen groups and two eyes (9.5%) in the MMC group. Based on survival analysis, CTT group had a cumulative success probability of 95.2% at three months, which dropped to 85.7% at six months and remained at that level for the 9th and 12th months of follow-up. With respect to the MMC group, the cumulative success probability at three months was 95.2%, dropped to 90.5% at six months, and remained at that level for the 9th and 12th months of follow-up. While in the Ologen group, the cumulative success probability at three months was 85.7% and remained at the same level during the 6th, 9th, and 12th months of follow-up, with p value = 0.862 using the logrank test.
CONCLUSION:
CTT is a safe and effective primary surgical intervention in patients with PCG without the need for augmentation while preserving the augmented procedure's use for recurrent cases.
