Steroid Induced Glaucoma
Conditions
Keywords
Trabeculectomy, Glaucoma, Steroids, Ologen, Viscoelastic
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.
Interventions
DEVICEOlogen 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.
DRUGProvisc
Provisc is an cohesive viscoelastic.
Sponsors
Aeon Astron Europe B.V.
National Centre of Ophthalmology named after academician Zarifa Aliyeva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure (IOP) | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | 2 years | 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. |
| Corrected distance visual acuity (CDVA) | 2 years | — |
| Appearance of the filtering bleb (FB) | 2 years | — |
Countries
Azerbaijan
Outcome results
None listed