NCT01912638

Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Provisc in Steroid Induced Glaucoma

Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this prospective randomized study is to assess and compare the clinical efficacy and safety of primary trabeculectomy with Ologen® collagen implant and cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically uncontrolled steroid induced glaucoma.

Detailed description

Steroid induced glaucoma is a well known and widely described disastrous clinical condition. However the subject of selection of most effective and safe treatment modality is still being discussed. Sihota R et al reported that 26.5% cases required surgical treatment to control IOP. Unfortunately survival rate of successful blebs in 10 years after trabeculectomy varies from 40% to 60%. Anti-fibrotic agent MMC as adjunct to filtration surgery was used to prevent postoperative scarring that could compromise surgical success of trabeculectomy. Additional use of MMC in trabeculectomy leads to low final IOP but could be associated with such complications as cataract formation, intraocular toxicity, avascular filtering blebs, wound leakage, subsequent blebitis and endophthalmitis. Tissue-engineered biodegradable and biocompatible implant Ologen® Collagen Matrix may be used as an alternative to MMC. Ologen® is CE Mark and FDA approved artificial porcine extracellular matrix for modulating wound healing. Ologen® has been tested in animal models and has triple action: 1. prevent the collapse of the subconjunctival space; 2. guides the fibroblast to grow through the matrix pores thus preventing scar formation; 3. may act as an aqueous reservoir (avoids post-op hyperfiltration and shallow anterior chamber). The filtering blebs scoring was performed by using Moorfields Bleb Grading System and Visante anterior segment optical coherence tomography.

Conditions

• Steroid Induced Glaucoma

Interventions

Type	Name	Description
DEVICE	Ologen Collagen Matrix	Ologen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed.
DRUG	Provisc	Provisc is an cohesive viscoelastic.

Timeline

• Start date: 2012-07-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2013-07-31
• Last updated: 2016-09-21

Locations

1 site across 1 country: Azerbaijan