Oculusgen (Ologen) Glaucoma MMC Control in Estonia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma; Angle Closure Glaucoma; Uveitis Glaucoma; Young Age Glaucoma; Neovascular Glaucoma; High Risk Patient	Device: ologen (oculusgen) collagen matrix; Drug: MMC in Trabeculectomy	Phase 3

Detailed Description:

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comprative Study of the Safety and Effectiveness Between Oculusgen (Ologen) Collagen Matrix Implant and Mitomycin-C in Glaucoma Filtering Surgery
Study Start Date :	July 2007
Actual Primary Completion Date :	October 2011
Actual Study Completion Date :	October 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Ologen in Trabeculectomy; Ologen in Trabeculectomy	Device: ologen (oculusgen) collagen matrix; 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
Active Comparator: MMC in Trabeculectomy; MMC in Trabeculectomy	Drug: MMC in Trabeculectomy; MMC in Trabeculectomy

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. IOP <21mmHg without anti glaucoma medication [ Time Frame: 180 days ]

Secondary Outcome Measures :

1. IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication [ Time Frame: 180-day ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Max anti glaucoma medication failed,

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Estonia
Tartu University Clinics
Tartu, Estonia

Sponsors and Collaborators

Pro Top & Mediking Company Limited

Investigators

Principal Investigator:	Kuldar Kaljurand, MD	University of Tartu

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:	NCT00524758 History of Changes
Other Study ID Numbers:	oculusgen 2006-02-20
First Posted:	September 5, 2007
Last Update Posted:	June 27, 2017
Last Verified:	June 2017

Keywords provided by Pro Top & Mediking Company Limited:

ologen; oculusgen; collagen matrix; trabeculectomy	filtering surgery; mitomycin-C; MMC; Aeon Astron

Additional relevant MeSH terms:

Glaucoma; Glaucoma, Open-Angle; Uveitis; Glaucoma, Angle-Closure; Glaucoma, Neovascular; Ocular Hypertension; Eye Diseases; Uveal Diseases	Mitomycins; Mitomycin; Antibiotics, Antineoplastic; Antineoplastic Agents; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors