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

Steroid Induced Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912638
• Other study ID #: Trab-Olo-SG
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 29, 2013
• Last updated: September 20, 2016
• Start date: July 2012
• Est. completion date: September 2016

Study information

• Verified date: July 2015
• Source: National Centre of Ophthalmology named after academician Zarifa Aliyeva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Azerbaijan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Glaucoma
• Steroid Induced Glaucoma

Intervention

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.

Locations

Country	Name	City	State
Azerbaijan	National Centre of Ophthalmology named after academician Zarifa Aliyeva	Baku

Sponsors (2)

Lead Sponsor	Collaborator
National Centre of Ophthalmology named after academician Zarifa Aliyeva	Aeon Astron Europe B.V.

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure (IOP)	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.	2 years	No
Secondary	Postoperative complications	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.	2 years	Yes
Secondary	Corrected distance visual acuity (CDVA)		2 years	No
Secondary	Appearance of the filtering bleb (FB)		2 years	Yes