Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery

Pro Top & Mediking

Status and phase: Completed; Phase 4

Conditions: Open Angle Glaucoma

Treatments: Device: Collagen Matrix in Glaucoma Filtering Surgery; Drug: Mitomycin-C(MMC) and glaucoma filtering surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00538590

ologen-Koln

Details and patient eligibility

About

To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.

Full description

To compare the safety and effectiveness in between oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) for glaucoma surgery. The surgery is performed by the gold standard of trabeculectomy. Mitomycin-C(MMC) is applied for those who not collagen matrix implanted.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Open angle glaucoma
• Maxima anti-glaucoma medication failed
• Age>18
• Able to complete the follow up

Exclusion criteria

• Topical eye inflammation
• Angle closure glaucoma
• Deformity glaucoma
• One eye glaucoma
• Previous conjunctiva opened
• Allergy to collagen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

MITOMYCIN-C

Active Comparator group

Description:

Following ethics committee approval, 20 patients with uncontrolled glaucoma will be will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with Mitomycin-C.

Treatment:

Drug: Mitomycin-C(MMC) and glaucoma filtering surgery

ologen (Oculusgen)

Experimental group

Description:

20 patients will be recruited according to the enrollment acceptance criteria. Randomisation is performed and patients are allocated for trabeculectomy with ologen implant. The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

Treatment:

Device: Collagen Matrix in Glaucoma Filtering Surgery