Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

NCT ID: NCT00477685

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-10-31

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.

Detailed Description

ologen collagen matrix is applied for the phacotrabec surgery.

Conditions

Glaucoma; Cataract

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

OculusGen Collagen Matrix

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

OculusGen Biodegradable Collagen Matrix Implant

Intervention Type: DEVICE

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Interventions

OculusGen Biodegradable Collagen Matrix Implant

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pro Top & Mediking Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SPS Grewal, MD

Role: PRINCIPAL_INVESTIGATOR

Grewal Eye Institute

Locations

Grewal Eye Institute

Chandigarh, , India

Countries

India

References

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. doi: 10.1167/iovs.06-0378.

Reference Type: RESULT

PMID: 17122118 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10937547 (View on PubMed)

Other Identifiers

OculusGen-2007-04-20

Identifier Type: OTHER

Identifier Source: secondary_id

Mediking 0704

Identifier Type: -

Identifier Source: org_study_id