Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

Pro Top & Mediking Company Limited40 enrolled

Overview

The purpose of this study is to compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery.

1. Study Objective: To compare the safety and effectiveness of the ologen (OculusGen) Biodegradable Collagen Matrix Implant and the MMC group in filtration surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. Study Design: The study is designed as an open-label, randomized, parallel, comparative study. Patients who meet the inclusion/exclusion criteria and sign informed consent will be included. After enrollment, patients will be randomized into two groups: trabeculectomy with OculusGen implant or trabeculectomy with mitomycin-C. 3. Follow-Up: There will be 7 post-operative and follow-up visits within 6 months of surgery: postoperative days 1, 7, 14, 30, 60, 90 and 180. A window of ± 7 days is allowed for the 30, 60, 90 day visits and ± 14 days for the 180 day visits. Further follow-up of subjects after the trial will be the responsibility of the investigator.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma Trabeculectomy

Interventions

ologen collagen matrix in glaucoma filtering surgeryDEVICE

If ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

MMC in glaucoma filtering surgeryDRUG

If mitomycin -C is applied, a single cellulose sponge soaked with MMC (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or over. * Uncontrolled glaucoma, with failed medical and laser treatment, requiring trabeculectomy. * Subject able and willing to cooperate with investigation plan. * Subject able and willing to complete postoperative follow-up requirements. * Subject willing to sign informed consent form. Exclusion Criteria: * Known allergic reaction to mitomycin-C or Bovine collagen. * Subject is on warfarin and discontinuation is not recommended. * Normal tension glaucoma. * Participation in an investigational study during the 30 days preceding trabeculectomy. * Ocular infection within 14 days prior to trabeculectomy. * Pregnant or breast-feeding women.

Locations (1)

RMC & Allied Hospital

Rawalpindi, Punjab Province, Pakistan

Outcomes

Primary Outcomes

the effectiveness via the reduction of IOP

Time frame: 180 day

Secondary Outcomes

the safety via the incidence of complications and adverse events.

Time frame: 180 day

Data from ClinicalTrials.gov

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