Comparison between Ologen implant and different concentrations of Mitomycin C as an adjuvant to trabeculectomy surgery

Abstract

Context: Trabeculectomy is the most common surgical procedure for treatment of glaucoma. To improve success rates, adjuvants were utilized as Mitomycin C (MMC) and Ologen implant.

Aims: This study aims to establish efficacy and safety of Ologen implant versus MMC in trabeculectomy.

Setting and design: A prospective, comparative clinical study was conducted at the Department of Ophthalmology, Assiut University, between December 2014 and April 2016.

Subjects and methods: Patients with primary open-angle glaucoma (OAG), primary narrow-angle glaucoma and secondary OAG were assigned equally to trabeculectomy with Ologen, 0.4 mg/mL or 0.2 mg/mL MMC. The study outcome measures were reduction in intra-ocular pressure (IOP), success rates, survival analysis, and rate of complications.

Statistical analysis used: SPSS software Version 17.0 (SPSS, Inc., IL, USA) was utilized.

Results: Thirty eyes were included in the study. Mean baseline IOP in Ologen, MMC 0.4 and MMC 0.2 groups were 27.43 ± 2.97, 28.4 ± 3.24, and 27.56 ± 2.69 mmHg, respectively. At week 24 follow-up, mean IOP in Ologen, MMC 0.4 and MMC 0.2 groups were 18.55 ± 3.18, 16.2 ± 3.22, and 16.93 ± 3.04 mmHg, respectively. No significant inter-group difference was noticed at any visits. Complete success was achieved in 10%, 40%, and 30%, whereas incomplete success in 70%, 50%, and 60%, respectively in Ologen, MMC 0.4 and MMC 0.2 groups. No treatment group difference was reported by Kaplan-Meier analysis. Shallow anterior chamber occurred more in Ologen and MMC 0.4 groups. A single case of serous choroidal effusion had occurred in MMC 0.4 group.

Conclusion: Ologen implant is a promising alternative to MMC for improving the success rate of trabeculectomy.

Keywords: Antimetabolite; filtering surgery; intraocular pressure.

Figure 1

Mean intraocular pressure change at follow-up visits in the study

Figure 2

Success rates (number of cases) at week 24 follow-up end point in the treatment groups at two target intraocular pressure levels

Figure 3

Kaplan–Meier cumulative probability curve of complete success at 15 mmHg target intraocular pressure in all treatment groups

Figure 4

Ultrasonography of the right eye revealed serous choroidal effusion (top). Two weeks later, follow-up US revealed resolution of choroidal effusion (bottom)

Figure 5

Slit-lamp photography of trabeculectomy 1 and and 6 months post-operatively. Top: Ologen, middle: MMC 0.2 mg/ml & bottom: MMC 0.4 mg/mlgroup