CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Mitomycin-C(MMC) and glaucoma filtering surgery +1 moredrug
Likely dose
Mitomycin-C(MMC) and 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/NCT00538590
NCT00538590Phase 4Completed
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Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Pro Top & Mediking Company Limited·interventional·Posted Oct 2, 2007·Updated Apr 25, 2012

In Brief

A Phase 4 clinical trial evaluating Collagen Matrix in Glaucoma Filtering Surgery and Mitomycin-C(MMC) and glaucoma filtering surgery for Open Angle Glaucoma. Completed, enrolled 20 participants across 1 site.

Detailed Summary

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpen Angle Glaucoma
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2, 2007
Enrollment StartJul 1, 2007
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.8 years ago

Interventions

Collagen Matrix in Glaucoma Filtering Surgerydevice

Collagen Matrix implantation in Glaucoma Filtering Surgery

Mitomycin-C(MMC) and glaucoma filtering surgerydrug

If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(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.