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

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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:
Information provided by (Responsible Party):

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
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Mitomycin
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538590


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:
Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00538590     History of Changes
Other Study ID Numbers: ologen-Koln
First Posted: October 2, 2007    Key Record Dates
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