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Randomized Controlled Trial
. 2013 Jul;61(7):338-42.
doi: 10.4103/0301-4738.109520.

Comparison of outcomes of trabeculectomy with mitomycin C vs. ologen implant in primary glaucoma

Sirisha Senthil  1 , Harsha L Rao, Jonnadula G Babu, Anil K Mandal, Chandra Sekhar Garudadri
Affiliations
Randomized Controlled Trial

Comparison of outcomes of trabeculectomy with mitomycin C vs. ologen implant in primary glaucoma

Sirisha Senthil et al. Indian J Ophthalmol. 2013 Jul.

Abstract

Purpose: To compare the safety and efficacy of trabeculectomy with Ologen implant vs. trabeculectomy with Mitomycin C (MMC).

Materials and methods: In a prospective, randomized, pilot study, 39 eyes of 33 subjects with medically uncontrolled primary glaucoma, aged 18 years or above underwent trabeculectomy either with MMC (20 eyes) or with Ologen implant (19 eyes). The primary outcome measure was cumulative success probability, defined as complete if the intraocular pressure (IOP) was > 5 and ≤ 21 mm Hg without anti-glaucoma medications or additional surgery and qualified if an IOP was > 5 and ≤ 21 mm Hg with or without anti-glaucoma medications.

Results: Mean (± standard deviation) follow-up in Ologen group was 19.1 ± 8.1 months, and in MMC group was 18.0 ± 8.4 months. Mean IOP reduction at 6 months was significantly lower (P = 0.01) in the MMC group (11.9 ± 2.9 mm Hg) as compared to Ologen group (14.6 ± 2.7 mm Hg). However, at 12 months (P = 0.81) and 24 months (P = 0.32), the mean IOP was similar between the 2 groups. Complete success probability at the end of 6 months in Ologen group was 100% (95% confidence interval: 59.1 - 99.0) was similar (P = 0.53) to that in MMC group (93.8%, 95% CI: 63.2 - 99.1). The incidences of early post-operative complications were similar in the 2 groups, except hyphema, which was significantly more in Ologen group (P = 0.02).

Conclusion: In this pilot study, the success of trabeculectomy and complications were similar in both Ologen and MMC groups at the end of 6 months.

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Conflict of interest statement

Conflict of Interest: None declared.

Figures

Figure 1
Figure 1
Biodegradable collagen matrix implant positioned directly above the scleral flap. Note the laser peripheral iridotomy at 11’0 clock and a surgical PI at 12’0 clock
Figure 2
Figure 2
2-week postoperative slitlamp photograph following trabeculectomy with Mitomycin C, showing a diffuse well formed bleb
Figure 3
Figure 3
2-week post-operative slitlamp photograph following trabeculectomy with collagen implant, showing an elevated bleb and sub-conjunctival implant
Figure 4
Figure 4
Kaplan-Meier survival analysis showing the survival probability of the 2 groups considering complete (a) and qualified (b) success criteria separately. The number of eyes at risk in both the groups at each time point is given below the graph
Figure 5
Figure 5
8-week postoperative slit lamp photograph of an eye with partially absorbed sub-conjunctival collagen implant
See this image and copyright information in PMC

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