Clinical trial NCT01912638: Trabeculectomy With Ologen Collagen Implant vs Trabeculectomy With Provisc in Steroid Induced Glaucoma
Official title: Comparative Study of the Efficacy and Safety of Ologen Collagen Implant Versus Cohesive Viscoelastic in Trabeculectomy Performed for Steroid Induced Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Steroid Induced Glaucoma
Keywords: Trabeculectomy
Glaucoma
Steroids
Ologen
Viscoelastic
Lead sponsor: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Sponsor class: OTHER_GOV
Collaborators: name: Aeon Astron Europe B.V.
First posted: 2013-07-31
Enrollment: 17
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 2 years
Secondary outcomes:
measure: Postoperative complications
timeFrame: 2 years
measure: Corrected distance visual acuity (CDVA)
timeFrame: 2 years
measure: Appearance of the filtering bleb (FB)
timeFrame: 2 years
Other outcomes:
Locations:
city: Baku
country: Azerbaijan
facility: National Centre of Ophthalmology named after academician Zarifa Aliyeva
Study officials:
affiliation: Director of National Centre of Ophthalmology
name: Elmar Kasimov, Professor
role: STUDY_DIRECTOR
affiliation: Glaucoma consultant at National Centre of Ophthalmology
name: Fidan Aghayeva, MD
role: PRINCIPAL_INVESTIGATOR
References: