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NCT Number: NCT00538590

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of Universität Köln

Cologne, 50931, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen Matrix in Glaucoma Filtering Surgery

Device

Collagen Matrix implantation in Glaucoma Filtering Surgery

Other names: ologen™

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.

Other names: Mitomycin C

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pro Top & Mediking Company Limited

Industry

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 2, 2007
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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