NCT00477685

Brief Summary

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 29, 2012

Completed
Last Updated

August 14, 2017

Status Verified

July 1, 2017

Enrollment Period

4.4 years

First QC Date

May 23, 2007

Results QC Date

October 24, 2011

Last Update Submit

July 1, 2017

Conditions

GlaucomaCataract

Keywords

GlaucomaCollagen matrixOculusGenPhacotrabeculectomyanti scarringtissue engineeringologenAeon Astron

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Any Complications or Adverse Events.

    180 day

Study Arms (1)

OculusGen Collagen Matrix

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

Device: OculusGen Biodegradable Collagen Matrix Implant

Interventions

OculusGen Biodegradable Collagen Matrix ImplantDEVICE

OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.

OculusGen Collagen Matrix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

10

You may qualify if:

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

You may not qualify if:

  • Known allergic reaction to collagen.
  • Subject is on Warfarin and discontinuation is not recommended.
  • Subject with normal tension glaucoma or aphakic glaucoma.
  • Subject with corneal disease.
  • Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
  • Ocular infection within 14 days prior to phacotrabeculectomy.
  • Pregnant or breast-feeding women.
  • Monocular subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grewal Eye Institute

Chandigarh, 500 034, India

Location

Related 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. doi: 10.1167/iovs.06-0378.

    PMID: 17122118RESULT

  • 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.

    PMID: 10937547RESULT

MeSH Terms

Conditions

GlaucomaCataract

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLens Diseases

Limitations and Caveats

Limited sample size.

Results Point of Contact

Title
S.P.S Grewal, MD
Organization
Grewal Eye Institute
drgrewal@gmail.com
+91-172-5056969

Study Officials

  • SPS Grewal, MD

    Grewal Eye Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

May 1, 2007

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 14, 2017

Results First Posted

March 29, 2012

Record last verified: 2017-07

Locations

IN(1)