CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
MMC in glaucoma filtering surgery +1 moredrug
Likely dose
MMC in glaucoma filtering surgery 0.2mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00472810
NCT00472810Phase 3Completed
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Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Pro Top & Mediking Company Limited·interventional·Posted May 14, 2007·Updated Oct 7, 2011

In Brief

A Phase 3 clinical trial evaluating ologen collagen matrix in glaucoma filtering surgery and MMC in glaucoma filtering surgery for Glaucoma and Trabeculectomy. Completed, enrolled 40 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Trabeculectomy
CountriesPakistan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 14, 2007
Enrollment StartMar 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 19.1 years ago

Interventions

ologen collagen matrix in glaucoma filtering surgerydevice

If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

MMC in glaucoma filtering surgerydrug

If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.