Secondary subconjunctival implantation of a biodegradable collagen-glycosaminoglycan matrix to treat ocular hypotony following trabeculectomy with mitomycin C

Dietlein, Thomas S.; Lappas, Alexandra; Rosentreter, André

doi:10.1136/bjophthalmol-2013-303357

Cited by 23 publications

(30 citation statements)

References 20 publications

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“…These are possible reasons, why OLO implants are used to manage ocular hypotony after glaucoma filtration surgery (Dietlein et al. ; Tanito et al. ).…”

Section: Discussionmentioning

confidence: 99%

Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Właź

Rozegnał-Madej

Żarnowski

2019

Acta Ophthalmologica

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Purpose: To compare the efficacy and safety of collagen matrix implant (Ologen â ; OLO) with mitomycin C (MMC) in phacotrabeculectomy. Methods: Prospective, single-centre, nonblinded, randomized controlled trial. A total of 53 eyes of 45 patients were enrolled in the study protocol with 27 eyes randomly assigned to OLO and 26 to MMC. The follow-up was 12 months. The primary outcome measure was mean change from baseline intraocular pressure (IOP) in both groups after 12 months. The secondary outcome measures were cumulative success rates at 12 months with Kaplan-Meier analysis, change in number of medications, change in best corrected visual acuity (BCVA), and bleb morphology assessed using Moorfields Bleb Grading System and anterior segment swept-source optical coherence tomography. Results: The mean IOP decreased from 26.4 AE 6.1 mmHg to 13.7 AE 3.8 in the OLO group and from 23.4 AE 3.6 mmHg to 13.3 AE 2.8 in the MMC group at 1 year without significant intergroup differences. At 1 year, the overall success rates were 92.6% and 92.3% in the OLO and MMC groups, respectively. There were no significant differences in the overall success rates, BCVA, number of medications, morphology of the filtering blebs and rate of complications at the end of the follow-up. Conclusion: Ologen (OLO) provides similar surgical outcomes in phacotrabeculectomy compared with adjunctive MMC. It may be a new, safe and effective alternative to MMC for combined phacoemulsification and trabeculectomy surgery.

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“…These are possible reasons, why OLO implants are used to manage ocular hypotony after glaucoma filtration surgery (Dietlein et al. ; Tanito et al. ).…”

Section: Discussionmentioning

confidence: 99%

Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Właź

Rozegnał-Madej

Żarnowski

2019

Acta Ophthalmologica

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“…It is our impression the conjunctiva is thicker and less avascular in eyes that underwent trabeculectomy with CM, reducing the risk of late hypotony. Indeed, the use of Ologen CM implantation to treat post-trabeculectomy hypotony has been reported [23]. Paradoxically, frank hypotony maculopathy occurred as an adverse event in two cases in the CM group.…”

Section: Discussionmentioning

confidence: 99%

Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial

et al. 2016

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BackgroundAntifibrotic agents are commonly utilized to enhance the success rates of trabeculectomy. Novel approaches to further improve success rates and reduce the risks of complications are needed. The purpose of this study was to compare intraocular pressure (IOP)-lowering efficacy and safety of trabeculectomy or combined phacoemulsification and trabeculectomy with mitomycin-C (MMC) vs. Collagen Matrix (CM).MethodsA prospective, multicenter, randomized controlled trial was performed. Ninety-five eyes of 94 patients with uncontrolled glaucoma despite medical therapy, without previous incisional glaucoma surgery underwent trabeculectomy (85 eyes) or combined phacoemulsification and trabeculectomy (10 eyes) and were randomized to MMC or CM. One eye of each subject was analyzed. Patients were followed for 24 months. The criteria for complete success were IOP >5 and ≤21 mmHg with at least a 20% reduction below medicated baseline without additional glaucoma surgery or medications. The main outcome measures were complete success rates at 24 months with Kaplan-Meier analysis and incidence of adverse events.ResultsThe baseline IOPs were 20.4 ± 6.0 mmHg and 21.2 ± 6.1 (mean ± standard deviation, p = 0.49) on 3.2 ± 1.1 and 3.1 ± 1.0 medications (p = 0.53) compared to 11.8 ± 5.2 and 12.8 ± 3.7 (p = 0.36) on 0.5 ± 0.8 and 0.6 ± 1.0 medications (p = 0.63) at 2 years in the MMC and CM groups, respectively. Kaplan-Meier analysis demonstrated complete success rates were similar in both groups at 24 months: 38.4 ± 7.6% with MMC and 56.2 ± 7.9% with CM (mean ± standard error, p = 0.112, log rank test); however, a significantly higher incidence of failure due to persistent hypotony was observed with MMC (p = 0.002).ConclusionsUse of the CM implant at the time of trabeculectomy or combined phacoemulsification and trabeculectomy is associated with similar complete success rates compared to adjunctive MMC; however, the risk of persistent hypotony is higher with MMC.Trial registrationClinicalTrials.gov registration number NCT01440751.Registered 9/14/11Electronic supplementary materialThe online version of this article (doi:10.1186/s12886-016-0393-z) contains supplementary material, which is available to authorized users.

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“…In the study of M Tanito, Ologen can be a useful therapeutic option for ocular hypotony after glaucoma filtration surgery [43] . The study of Dietlein TS showed that subconjunctival implantation of collagen matrix may present an additional surgical tool in the treatment of symptomatic ocular hypotony after filtering surgery [44] . However, the meta-analysis In the present study , there was no statistically significant difference between the two groups in reducing the IOP.…”

Section: Discussionmentioning

confidence: 99%

Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

Liu¹,

Du²,

Mei³

et al. 2019

Preprint

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Objective To evaluate the effectiveness and safety of the biodegradable collagen matrix (Ologen) implant in trabeculectomy. Research design and methods We searched Pubmed, Cochrane library, Embase and Web of Science databases to find studies that met our pre-stated inclusion criteria. Reference lists of retrieved articles were also reviewed. The search was finished by February 2019. Study selection, data extraction, quality assessment, and data analyses were performed according to the Cochrane standards. Either a fixed or a random-effects model was used to calculate the overall combined risk estimates. The efficacy measures were the weighted mean differences (WMDs) for the intraocular pressure reduction (IOPR) and the glaucoma medications reduction, the odds ratio (OR) for the success rate and adverse events. Results Fifteen randomized controlled trials involved 682 eyes were included in the meta-analysis. There were no statistically differences between two groups in the IOPR at any time postoperatively. The MD of the IOPR was [MD= -0.45,95% Confidence Interval (CI), (-2.36,1.46), P=0.65] at one day, [MD= -0.82,95% CI, (-1.97, 0.33), P=0.16] at one week, [MD= -1.33, 95% CI,(-3.12, 0.47), P=0.15] at one month, [MD= 0.11,95% CI, (-1.87, 2.08), P=0.92] at three months, [MD= -0.60,95% CI, (-2.27, 1.06), P=0.48] at six months, [MD= -0.33,95% CI, (-1.99, 1.32), P=0.69] at one year, [MD= -0.13,95% CI, (-1.90, 1.65), P=0.89] at two years, [MD= 2.54,95% CI, (-2.83, 7.90), P=0.35] at three years, [MD= 3.04,95% CI, (-3.95, 10.03), P=0.39] at five years. There was no statistically significant difference between the Ologen groups and MMC groups concerned the complete success rate [OR=1.19, 95%CI, (0.83, 1.71), P=0.35]. With regard to the adverse events, no obvirously significance was observed. Seven studies reported the change of antiglaucoma medications. We found that the change of antiglaucoma medications is higher in MMC groups than that in Ologen groups [MD=-0.18, 95%CI, (-0.33, -0.03), P=0.02]. There is no significant difference in complications between the two groups. Conclusions From the current evidence, Ologen may be an alternative choice for trabeculectomy when considering the efficacy and safety. However, MMC might be the preferred choice concerned cost-effectiveness.

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Secondary subconjunctival implantation of a biodegradable collagen-glycosaminoglycan matrix to treat ocular hypotony following trabeculectomy with mitomycin C

Cited by 23 publications

References 20 publications

Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial

Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

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Secondary subconjunctival implantation of a biodegradable collagen-glycosaminoglycan matrix to treat ocular hypotony following trabeculectomy with mitomycin C

Cited by 23 publications

References 20 publications

Phacotrabeculectomy using collagen matrix implant (Ologen®) versus mitomycin C: a prospective randomized controlled trial

Phacotrabeculectomy using collagen matrix implant (Ologen®) versus mitomycin C: a prospective randomized controlled trial

Collagen matrix vs mitomycin-C in trabeculectomy and combined phacoemulsification and trabeculectomy: a randomized controlled trial

Comparison between Ologen implant and Mitomycin C in trabeculectomy: A Systematic Review and Meta-Analysis

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Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial

Phacotrabeculectomy using collagen matrix implant (Ologen^®) versus mitomycin C: a prospective randomized controlled trial