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Oculusgen (Ologen) Glaucoma MMC Control in Estonia

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00524758
Enrollment
20
Registered
2007-09-05
Start date
2007-07-31
Completion date
2011-10-31
Last updated
2017-06-27

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

Conditions

Angle Closure Glaucoma, High Risk Patient, Neovascular Glaucoma, Open Angle Glaucoma, Uveitis Glaucoma, Young Age Glaucoma

Keywords

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

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.

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.

Interventions

DEVICEologen (oculusgen) collagen matrix

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

DRUGMMC in Trabeculectomy

MMC in Trabeculectomy

Sponsors

Pro Top & Mediking Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Max anti glaucoma medication failed,

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
IOP <21mmHg without anti glaucoma medication180 days

Secondary

MeasureTime frame
IOP<21mmHg or IOP drops more than 30% with anti glaucoma medication180-day

Countries

Estonia

Outcome results

None listed

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