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Oculusgen (Ologen) Glaucoma MMC Control in Estonia

P

Pro Top & Mediking

Status and phase

Completed
Phase 3

Conditions

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

Treatments

Device: ologen (oculusgen) collagen matrix
Drug: MMC in Trabeculectomy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00524758
oculusgen 2006-02-20

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Max anti glaucoma medication failed,

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Ologen in Trabeculectomy
Experimental group
Description:
Ologen in Trabeculectomy
Treatment:
Device: ologen (oculusgen) collagen matrix
MMC in Trabeculectomy
Active Comparator group
Description:
MMC in Trabeculectomy
Treatment:
Drug: MMC in Trabeculectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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