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Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00477685
First received: May 23, 2007
Last updated: February 24, 2014
Last verified: February 2014
  Purpose
  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.

Condition Intervention Phase
Glaucoma
Cataract
Device: OculusGen Biodegradable Collagen Matrix Implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • Preoperative and Postoperative Intraocular Pressure [ Time Frame: baseline and 90 days ] [ Designated as safety issue: No ]
    The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.


Secondary Outcome Measures:
  • Number of Participants With Any Complications or Adverse Events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]
    Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.


Enrollment: 10
Study Start Date: May 2007
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OculusGen Collagen Matrix
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Device: OculusGen Biodegradable Collagen Matrix Implant
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Subject inclusion criteria:

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

Subject exclusion criteria:

  1. Known allergic reaction to collagen.
  2. Subject is on Warfarin and discontinuation is not recommended.
  3. Subject with normal tension glaucoma or aphakic glaucoma.
  4. Subject with corneal disease.
  5. Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
  6. Ocular infection within 14 days prior to phacotrabeculectomy.
  7. Pregnant or breast-feeding women.
  8. Monocular subject.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477685

Locations
India
Grewal Eye Institute
Chandigarh, India, 500 034
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: SPS Grewal, MD Grewal Eye Institute
  More Information

Publications:
Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00477685     History of Changes
Other Study ID Numbers: Mediking 0704, OculusGen-2007-04-20
Study First Received: May 23, 2007
Results First Received: October 24, 2011
Last Updated: February 24, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Pro Top & Mediking Company Limited:
Glaucoma
Collagen matrix
OculusGen
Phacotrabeculectomy
anti scarring
tissue engineering
ologen
Aeon Astron

Additional relevant MeSH terms:
Glaucoma
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 23, 2014