Trial Outcomes & Findings for Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India (NCT NCT00477685)

Results Overview

The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.

Recruitment status

COMPLETED

Target enrollment

10 participants

Primary outcome timeframe

baseline and 90 days

Results posted on

2017-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	OculusGen Collagen Matrix OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ologen (OculusGen)-Phacotrabeculectomy Historical Control Study in India

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OculusGen Collagen Matrix n=10 Participants OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	65 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment India	10 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 90 days

The preoperative and postoperative intraocular pressure is measured as mmHg at baseline and 90 days.

Outcome measures

Outcome measures
Measure	OculusGen Collagen Matrix n=10 Participants OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Preoperative and Postoperative Intraocular Pressure Preoperative intraocular pressure	20.1 mm Hg Standard Deviation 8.02
Preoperative and Postoperative Intraocular Pressure Postoperative intraocular pressure	9 mm Hg Standard Deviation 3.32

SECONDARY outcome

Timeframe: 180 day

Observation of the incidence of complications, including transient shallow anterior chamber, hyphema, choroidal detachment, hypotony or endophthalmitis.

Outcome measures

Outcome measures
Measure	OculusGen Collagen Matrix n=10 Participants OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
Number of Participants With Any Complications or Adverse Events.	0 participants

Adverse Events

OculusGen Collagen Matrix

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

S.P.S Grewal, MD

Grewal Eye Institute

Phone: +91-172-5056969

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place