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Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

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.
ClinicalTrials.gov Identifier: NCT00477685
Recruitment Status : Completed
First Posted : May 24, 2007
Results First Posted : March 29, 2012
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
  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 or disease Intervention/treatment
Glaucoma Cataract Device: OculusGen Biodegradable Collagen Matrix Implant

Detailed Description:
ologen collagen matrix is applied for the phacotrabec surgery.

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Study of the Safety and Effectiveness of the OculusGenTM Collagen Matrix Implant as an Aid in Phacotrabeculectomy Surgery
Study Start Date : May 2007
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
OculusGen Collagen Matrix
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Device: OculusGen Biodegradable Collagen Matrix Implant
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


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
Sampling Method:   Non-Probability Sample
Study Population
10
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

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): 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 ( Other Identifier: Aeon Astron Europe B.V. )
First Posted: May 24, 2007    Key Record Dates
Results First Posted: March 29, 2012
Last Update Posted: August 14, 2017
Last Verified: July 2017

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
Cataract
Ocular Hypertension
Eye Diseases
Lens Diseases