N/A
N=10
Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India
Glaucoma · Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00477685 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Preoperative and Postoperative Intraocular Pressure — 20.1; 9 mm Hg — p=0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- OculusGen Biodegradable Collagen Matrix Implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pro Top & Mediking Company Limited
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preoperative and Postoperative Intraocular Pressure |
20.1; 9 | 0.01 sig |
| SECONDARY Number of Participants With Any Complications or Adverse Events. |
— | — |
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.
Eligibility Criteria
Subject inclusion criteria:
- 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.
Subject exclusion criteria:
- 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.
Data sourced from ClinicalTrials.gov (NCT00477685). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.