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

NCT ID: NCT01912638

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-09-30

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.

Conditions

Steroid Induced Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implantation of Ologen in trabeculectomy

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.

Group Type: EXPERIMENTAL

Ologen Collagen Matrix

Intervention Type: DEVICE

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.

Provisc in trabeculectomy

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.

Group Type: ACTIVE_COMPARATOR

Provisc

Intervention Type: DRUG

Provisc is an cohesive viscoelastic.

Interventions

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.

Intervention Type: DEVICE

Provisc

Provisc is an cohesive viscoelastic.

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aeon Astron Europe B.V.

INDUSTRY

Sponsor Role: collaborator

National Centre of Ophthalmology named after academician Zarifa Aliyeva

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elmar Kasimov, Professor

Role: STUDY_DIRECTOR

Director of National Centre of Ophthalmology

Fidan Aghayeva, MD

Role: PRINCIPAL_INVESTIGATOR

Glaucoma consultant at National Centre of Ophthalmology

Locations

National Centre of Ophthalmology named after academician Zarifa Aliyeva

Baku, , Azerbaijan

Countries

Azerbaijan

References

Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

Reference Type: DERIVED

PMID: 36912740 (View on PubMed)

Other Identifiers

Trab-Olo-SG

Identifier Type: -

Identifier Source: org_study_id