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

• ClinicalTrials.gov Identifier: NCT00538590
• Recruitment Status: Completed
• First Posted: October 2, 2007
• Results First Posted: April 25, 2012
• Last Update Posted: April 25, 2012
• Sponsor: Pro Top & Mediking Company Limited
• Information provided by (Responsible Party): Pro Top & Mediking Company Limited

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Open Angle Glaucoma	Device: Collagen Matrix in Glaucoma Filtering Surgery; Drug: Mitomycin-C(MMC) and glaucoma filtering surgery	Phase 4

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
• Study Start Date: July 2007
• Actual Primary Completion Date: August 2010
• Actual Study Completion Date: August 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: MITOMYCIN-C; 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.	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.; Other Name: Mitomycin C
Experimental: ologen (Oculusgen); 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.	Device: Collagen Matrix in Glaucoma Filtering Surgery; Collagen Matrix implantation in Glaucoma Filtering Surgery; Other Name: ologen™

Outcome Measures

Primary Outcome Measures :

1. Postoperative Intraocular Pressure Change [ Time Frame: 360 days ]
   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.
2. Postoperative Intraocular Pressure Change [ Time Frame: 180 days ]
   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.
3. Postoperative Intraocular Pressure Change [ Time Frame: 90 days ]
   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.
4. Postoperative Intraocular Pressure Change [ Time Frame: 30 days ]
   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.

Secondary Outcome Measures :

1. Complications [ Time Frame: 360 days ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Germany

Hospital of Universität Köln

Koln, Germany, 50931

Sponsors and Collaborators

Pro Top & Mediking Company Limited

Investigators

• Principal Investigator: Thomas Dietlein, Ph. D, MD; Universität Köln

More Information

Additional Information:

ologen collagen matrix website. 

Publication on Eye 

• Responsible Party: Pro Top & Mediking Company Limited
• ClinicalTrials.gov Identifier: NCT00538590
• Other Study ID Numbers: ologen-Koln
• First Posted: October 2, 2007
• Results First Posted: April 25, 2012
• Last Update Posted: April 25, 2012
• Last Verified: April 2012

Keywords provided by Pro Top & Mediking Company Limited:

ologen; collagen matrix; glaucoma; trabeculectomy; Mitomycin-C

Additional relevant MeSH terms:

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