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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538590
First Posted: October 2, 2007
Last Update Posted: April 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
September 29, 2007
October 2, 2007
January 19, 2012
April 25, 2012
April 25, 2012
July 2007
August 2010   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
  • 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.
IOP<18mmHg at 180 days after surgery without anti-glaucoma medication
Complete list of historical versions of study NCT00538590 on ClinicalTrials.gov Archive Site
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.
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Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
Ologen Collagen Matrix Safety and Effective Comparison With Mitomycin-C(MMC) in Glaucoma Surgery
To compare the safety and effectiveness of oculusgen (ologen) collagen matrix implantation and Mitomycin-C(MMC) in glaucoma surgery.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Open Angle Glaucoma
  • Device: Collagen Matrix in Glaucoma Filtering Surgery
    Collagen Matrix implantation in Glaucoma Filtering Surgery
    Other Name: ologen™
  • 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
  • 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.
    Intervention: Drug: Mitomycin-C(MMC) and glaucoma filtering surgery
  • 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.
    Intervention: Device: Collagen Matrix in Glaucoma Filtering Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2010
August 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00538590
ologen-Koln
Yes
Not Provided
Not Provided
Pro Top & Mediking Company Limited
Pro Top & Mediking Company Limited
Not Provided
Principal Investigator: Thomas Dietlein, Ph. D, MD Universität Köln
Pro Top & Mediking Company Limited
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP