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

NCT00538590 | Completed Phase 4 Results DMC

• 1 other identifier: ologen-Koln
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Open Angle Glaucoma

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (1)

• Complications

  360 days

Study Arms (2)

MITOMYCIN-C

ACTIVE COMPARATOR

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

ologen (Oculusgen)

EXPERIMENTAL

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

Interventions

Collagen Matrix in Glaucoma Filtering Surgery DEVICE

Collagen Matrix implantation in Glaucoma Filtering Surgery

Also known as: ologen™

ologen (Oculusgen)

Mitomycin-C(MMC) and glaucoma filtering surgery DRUG

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.

Also known as: Mitomycin C

MITOMYCIN-C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pro Top & Mediking Company Limited: lead

Study Sites (1)

Hospital of Universität Köln

Cologne, 50931, Germany

Location

Related Publications (1)

• Park J, Rittiphairoj T, Wang X, E JY, Bicket AK. Device-modified trabeculectomy for glaucoma. Cochrane Database Syst Rev. 2023 Mar 13;3(3):CD010472. doi: 10.1002/14651858.CD010472.pub3.

  PMID: 36912740 DERIVED

Related Links

• Publication on Eye

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Stat Methods and limited sample size.

Results Point of Contact

• Title: Thomas Dietlein, Ph. D., MD
• Organization: Hospital of Universität Köln

thomas.dietlein@uk-koeln.de

+49 221 4785862

Study Officials

• Thomas Dietlein, Ph. D, MD

  Universität Köln

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2007
• First Posted: October 2, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 25, 2012
• Results First Posted: April 25, 2012

Record last verified: 2012-04

Locations

DE (1)