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

Phase 1

Completed

• Conditions: Steroid Induced Glaucoma
• Interventions: Device: Ologen Collagen Matrix; Drug: Provisc

• Registration Number: NCT01912638
• Lead Sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva

Brief 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-07-31
• Status Verified: 2015-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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
• Preliminary conjunctival damage (trauma, vitreo-retinal surgery, previous glaucoma or strabismus surgery, etc)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implantation of Ologen in trabeculectomy	Ologen Collagen Matrix	Ologen Collagen Matrix is implanted in primary limbal-based trabeculectomy. It should be placed on the top of the loosely-sutured scleral flap before suturing of the conjunctiva thus preventing the collapse of the subconjunctival space.
Provisc in trabeculectomy	Provisc	Provisc is used in primary limbal-based trabeculectomy. At the end of the surgery cohesive viscoelastic (Provisc) is injected under the scleral flap to prevent early hypotony.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure (IOP)	2 years	The absolute success was defined as an IOP less than 21 mmHg with no glaucoma medications.; Follow-up visits were and will arranged at 1 and 2 first weeks, then every month during first 6 months, then every 3 months during 2.5 years after surgery.

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	2 years	Complications were defined as follows: hypotony,shallow anterior chamber,serous or hemorrhagic choroidal detachment, hyphema,anterior chamber inflammation,persistent hypotonus maculopathy,corneal epithelial toxicity, "snuff" syndrome,blebitis or endophthalmitis,formation of Tenon's cyst.
Corrected distance visual acuity (CDVA)	2 years
Appearance of the filtering bleb (FB)	2 years

Trial Locations

Locations (1)

National Centre of Ophthalmology named after academician Zarifa Aliyeva; 🇦🇿 Baku, Azerbaijan