Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

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

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Cataract
• Intervention / Treatment: Device: OculusGen Biodegradable Collagen Matrix Implant

Detailed Description

ologen collagen matrix is applied for the phacotrabec surgery.

• Study Type: Observational
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 500 034
    • Grewal Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

10

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative and Postoperative Intraocular Pressure	The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.	baseline and 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Pro Top & Mediking Company Limited
• Investigators: Principal Investigator: SPS Grewal, MD, Grewal Eye Institute

Publications and helpful links

General Publications

• 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. Erratum In: Invest Ophthalmol Vis Sci. 2007 Feb;48(2):485.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (Estimate): May 24, 2007

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: July 1, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Glaucoma; tissue engineering; ologen; Phacotrabeculectomy; Aeon Astron; Collagen matrix; OculusGen; anti scarring
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Lens Diseases; Glaucoma; Cataract
• Other Study ID Numbers: Mediking 0704; OculusGen-2007-04-20 (Other Identifier: Aeon Astron Europe B.V.)