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

National Centre of Ophthalmology named after academician Zarifa Aliyeva

Status and phase: Completed; Phase 2; Phase 1

Conditions: Steroid Induced Glaucoma

Treatments: Device: Ologen Collagen Matrix; Drug: Provisc

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01912638

Trab-Olo-SG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Implantation of Ologen in trabeculectomy

Experimental group

Description:

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.

Treatment:

Device: Ologen Collagen Matrix

Provisc in trabeculectomy

Active Comparator group

Description:

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.

Treatment:

Drug: Provisc