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