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Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Mitomycin C and Provisc in Steroid Induced Glaucoma

Information source: National Centre of Ophthalmology named after academician Zarifa Aliyeva
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Steroid Induced Glaucoma

Intervention: Ologen Collagen Matrix (Device); Mitomycin C (MMC) and Provisc (Drug)

Phase: Phase 1/Phase 2

Status: Enrolling by invitation

Sponsored by: National Centre of Ophthalmology named after academician Zarifa Aliyeva

Official(s) and/or principal investigator(s):
Elmar Kasimov, Professor, Study Director, Affiliation: Director of National Centre of Ophthalmology
Fidan Aghayeva, MD, Principal Investigator, Affiliation: Glaucoma consultant at National Centre of Ophthalmology

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 Mitomycin C

(MMC)-cohesive viscoelastic (Provisc®) - augmented trabeculectomy in patients with medically

uncontrolled steroid induced glaucoma.

Clinical Details

Official title: Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Mitomycin-C and Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Intraocular Pressure (IOP)

Secondary outcome:

Postoperative complications

Corrected distance visual acuity (CDVA)

Appearance of the filtering bleb (FB)

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.

Eligibility

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age > 16 years (inclusive)

- Patients with medically uncontrolled steroid induced glaucoma

Exclusion Criteria:

- Primary open angle glaucoma, angle-closure glaucoma, post-traumatic, uveitic,

neovascular, or dysgenetic glaucoma

- Known allergic reaction to porcine collagen or MMC

- Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or

strabismus surgery, etc)

Locations and Contacts

National Centre of Ophthalmology named after academician Zarifa Aliyeva, Baku AZ1114, Azerbaijan
Additional Information

Starting date: July 2012
Last updated: July 18, 2015

Page last updated: August 23, 2015

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