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OpenTrials
Completed

NCT Number: NCT00524758

Oculusgen (Ologen) Glaucoma MMC Control in Estonia

To compare the safety and effectiveness between ologen collagen matrix and mitomycin-C (MMC) in glaucoma surgery.

The ologen collagen matrix implantation procedure is same as traditional trabeculectomy except implant the ologen collagen matrix on the top of sclera flap after one loose stich the sclera flap. The MMC application is as the standard.

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Key information

Conditions

Open Angle Glaucoma Angle Closure Glaucoma Eye Diseases Glaucoma Glaucoma, Angle-Closure Glaucoma, Neovascular Glaucoma, Open-Angle High Risk Patient Neovascular Glaucoma Ocular Hypertension Uveitis Glaucoma Young Age Glaucoma

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tartu University Clinics

Tartu, Estonia

About this study

Ologen collagen matrix is implanted on the top of sclera flap after the loose stich sclera flap is done for the filtering surgery. The concept of ologen collagen matrix is to creat the subconjunctiva bleb and modulate the wound healing for the surgery. By implanting ologen collagen matrix in the place, subconjuctival and trabdoor scars might be prevented. This is because the ologen collagen matrix is a 3-D scaffold porous structure that can guide fibroblast to grow randomly, instead of linear alignment. This can reduce the scar formation.

Doctors apply MMC for the glaucoma surgery is also trying to inhibite the scar formation. But MMC has been long time used and glaucoma specialists have not found anything to replace it.

Ologen collagen matrix concept is not INHIBITION, it is guiding and creating a physiological tissue. The successful of ologen collagen matrix may be on par with MMC but the safety and side effects will be much less.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Max anti glaucoma medication failed,

Exclusion criteria

  • Age less than 18, woman in pregnant, hemodialysis patient

Treatment and study plan

ologen (oculusgen) collagen matrix

Device

Implant ologen collagen matrix on the top of sclera flap after loose stiched the sclera flap. The traditional trabeculectomy is performed.

Other names: ologen collagen matrix, oculusgen collagen matrix

MMC in Trabeculectomy

Drug

MMC in Trabeculectomy

Primary outcomes

  1. IOP <21mmHg without anti glaucoma medication

    Time frame: 180 days

Secondary outcomes

  1. IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication

    Time frame: 180-day

Sponsors and collaborators

Lead sponsor

Pro Top & Mediking Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 5, 2007
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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