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NCT00538590 Clinical Trial

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

Open Angle Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00538590
Other study ID # ologen-Koln
Secondary ID
Status Completed
Phase Phase 4
First received September 29, 2007
Last updated April 1, 2012
Start date July 2007
Est. completion date August 2010

Study information
Verified date April 2012
Source Pro Top & Mediking Company Limited
Contact n/a
Is FDA regulated No
Health authority Bundesinstitut für Arzneimittel und Medizinprodukte in Bonn: Germany
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Collagen Matrix in Glaucoma Filtering Surgery
Collagen Matrix implantation in Glaucoma Filtering Surgery
Drug:
• Mitomycin-C(MMC) and glaucoma filtering surgery
If mitomycin -C is applied, a single cellulose sponge soaked with Mitomycin-C(MMC) (0.2mg/ml - 0.4mg/ml) is fashioned into an approximate 2.0 × 4.0 mm rectangular shape and applied to the scleral bed and subconjunctival space taking care to avoid exposure to the conjunctival wound edge. Application time is 2 minutes for MMC. Then, the area treated is copiously irrigated with balanced salt solution. After operation, appropriate anti-inflammatory and antibiotic eye-drops will be prescribed.

Locations
Country Name City State
Germany Hospital of Universität Köln Koln

Sponsors (1)
Lead Sponsor Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative Intraocular Pressure Change Postoperative intraocular pressure change at 360 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. 360 days No
Primary Postoperative Intraocular Pressure Change Postoperative intraocular pressure change at 180 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. 180 days No
Primary Postoperative Intraocular Pressure Change Postoperative intraocular pressure change at 90 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. 90 days No
Primary Postoperative Intraocular Pressure Change Postoperative intraocular pressure change at 30 days compared to baseline (preoperative) intraocular pressure measured in mmHg. Calculated as postoperative intraocular pressure minus baseline (preoperative) intraocular pressure. 30 days No
Secondary Complications Incidence (percentage) for complications recorded: Hyphema, early hypotony(<7days), late hypotony(>7days), shallow anterior chamber, choroidal detachment, early leak(<7days), late leak(>7days), Tenon's cysts, and revision surgery for up to 360 days. 360 days Yes
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