Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study - Full Text View

Sponsored by:	Pro Top & Mediking Company Limited
Information provided by:	Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:	NCT00687791

Purpose

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

Condition	Intervention	Phase
Cataract Glaucoma	Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Cataract Glaucoma

Drug Information available for: Mitomycin Mitomycins

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:

The primary endpoint is to prove the effectiveness via the reduction of IOP. [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the secondary endpoint is to prove the safety via the reduction of complications. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor.	Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Arms

Assigned Interventions

1: Experimental

20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2> Phacotrabeculectomy is performed.3> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor.

Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Detailed Description:

Ologen™ Collagen Matrix is indicated for creating a mature bleb structure to facilitate aqueous outflow for the reduction of elevated intraocular pressure in patients with glaucoma, following traditional filtering surgery (trabeculectomy)

Within 60 days from the time of implantation, ologen™ Collagen Matrix is totally degraded. Postoperatively, mild inflammation may be seen and anti- inflammatory agents are prescribed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00687791

Contacts

Contact: Aung Tin, PhD MD

+65-62277255

aung.tin@snec.com.sg

Locations

Singapore
Singapore Eye Research Institute	Recruiting
Singapore, Singapore, 168751

Sponsors and Collaborators

Pro Top & Mediking Company Limited

Investigators

Study Chair:

Aung Tin, PhD MD

Singapore Eye Research Institute

More Information

Product background and description This link exits the ClinicalTrials.gov site

Responsible Party:	Singapore Eye Research Institute ( Assoc. Prof. Aung Tin )
Study ID Numbers:	Mediking 0706
Study First Received:	May 28, 2008
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00687791
Health Authority:	Singapore: Ministry of Health

Keywords provided by Pro Top & Mediking Company Limited:

patients with cataract and glaucoma
ologen
oculusgen
collagen matrix
Phacotrabeculectomy

Aeon Astron
trabeculectomy
tissue engineering
mitomycin-C

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Cataract
Mitomycin

Lens Diseases
Mitomycins
Hypertension
Ocular Hypertension

ClinicalTrials.gov processed this record on January 16, 2009