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

NCT01912638 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-09-21

No results posted yet for this study

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.

Conditions

  • Steroid Induced Glaucoma

Interventions

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.

Sponsors & Collaborators

  • Aeon Astron Europe B.V.

    collaborator INDUSTRY

  • National Centre of Ophthalmology named after academician Zarifa Aliyeva

    lead OTHER_GOV

Principal Investigators

  • Elmar Kasimov, Professor · Director of National Centre of Ophthalmology

  • Fidan Aghayeva, MD · Glaucoma consultant at National Centre of Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Azerbaijan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01912638 on ClinicalTrials.gov