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Completed

NCT Number: NCT00477685

Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

1. . Study Objective: The objective of this study is to determine the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in phacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of Intraocular Pressure, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events. 2. . Study Design: The study is designed as a historical controlled study. Patient who meet the inclusion/exclusion criteria and sign the informed consent form will be included for this study. The allocation of subjects is non-randomized, and there is a single group for assignment. 3. . Follow-Up: This investigation is including 7 post-operative visits and follow-up within 6 months from the date of surgery. Patients should be seen at postoperative days 1, 7, 14, 30, 60, 90 and 180. The visit window of ± 7 days is allowed for the 30, 60, 90 and 180 day visits. The further follow-up of subject after trial is continually tracked by the investigator.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grewal Eye Institute

Chandigarh, 500 034, India

About this study

ologen collagen matrix is applied for the phacotrabec surgery.

Who can participate

Healthy volunteers accepted: No

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

Subject inclusion criteria:

  • Age 18 years or over.
  • At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
  • Visually significant cataract with visual acuity of less than or equal to 6/12.
  • Subject able and willing to cooperate with investigation plan.
  • Subject willing to sign informed consent form.

Subject exclusion criteria:

  • Known allergic reaction to collagen.
  • Subject is on Warfarin and discontinuation is not recommended.
  • Subject with normal tension glaucoma or aphakic glaucoma.
  • Subject with corneal disease.
  • Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
  • Ocular infection within 14 days prior to phacotrabeculectomy.
  • Pregnant or breast-feeding women.
  • Monocular subject.

Treatment and study plan

OculusGen Biodegradable Collagen Matrix Implant

Device

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Primary outcomes

  1. Preoperative and Postoperative Intraocular Pressure

    Time frame: baseline and 90 days

    The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.

Secondary outcomes

  1. Number of Participants With Any Complications or Adverse Events.

    Time frame: 180 day

    Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.

Sponsors and collaborators

Lead sponsor

Pro Top & Mediking Company Limited

Industry

Registry information

Official study title

Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
May 24, 2007
Registry last updated
Aug 14, 2017

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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