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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Pro Top & Mediking Company Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00687791
First received: May 28, 2008
Last updated: June 17, 2008
Last verified: June 2008
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

Resource links provided by NLM:


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
Experimental: 1
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
Other Name: OculusGen (ologen™)

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:

  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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Cataract
Glaucoma
Eye Diseases
Lens Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on October 20, 2014