Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477685
• Other study ID #: Mediking 0704
• Secondary ID: OculusGen-2007-0
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2007
• Last updated: February 24, 2014
• Start date: May 2007
• Est. completion date: October 2011

Study information

• Verified date: February 2014
• Source: Pro Top & Mediking Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Glaucoma

Intervention

Device:
• OculusGen Biodegradable Collagen Matrix Implant
OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Locations

Country	Name	City	State
India	Grewal Eye Institute	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Pro Top & Mediking Company Limited

Country where clinical trial is conducted

India, 

References & Publications (2)

Chen HS, Ritch R, Krupin T, Hsu WC. Control of filtering bleb structure through tissue bioengineering: An animal model. Invest Ophthalmol Vis Sci. 2006 Dec;47(12):5310-4. Erratum in: Invest Ophthalmol Vis Sci. 2007 Feb;48(2):485. — View Citation

Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preoperative and Postoperative Intraocular Pressure	The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.	baseline and 90 days	No
Secondary	Number of Participants With Any Complications or Adverse Events.	Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.	180 day	Yes