Ologen (OculusGen)-Glaucoma MMC Control in Pakistan

Comparative Study of the Safety and Effectiveness Between Ologen (OculusGen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00472810

Enrollment

Registered

2007-05-14

Start date

2007-03-31

Completion date

Unknown

Last updated

2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Trabeculectomy

Keywords

Glaucoma, Collagen matrix, ologen, OculusGen, Antifibrotic, Trabeculectomy, anti scarring, tissue engineering, high risk patient for trabeculectomy, Aeon Astron

Brief summary

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.

Detailed description

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.

Interventions

DEVICEologen collagen matrix in glaucoma filtering surgery

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

DRUGMMC in glaucoma filtering surgery

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
the effectiveness via the reduction of IOP	180 day

Secondary

Measure	Time frame
the safety via the incidence of complications and adverse events.	180 day

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026