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

Primary Purpose

Cataract, Glaucoma

Status
Unknown status
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
Sponsored by
Pro Top & Mediking Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring patients with cataract and glaucoma, ologen, oculusgen, collagen matrix, Phacotrabeculectomy, Aeon Astron, trabeculectomy, tissue engineering, mitomycin-C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Singapore Eye Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

The primary endpoint is to prove the effectiveness via the reduction of IOP.

Secondary Outcome Measures

the secondary endpoint is to prove the safety via the reduction of complications.

Full Information

First Posted
May 28, 2008
Last Updated
June 17, 2008
Sponsor
Pro Top & Mediking Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00687791
Brief Title
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
Official Title
Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2008 (Anticipated)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Pro Top & Mediking Company Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Glaucoma
Keywords
patients with cataract and glaucoma, ologen, oculusgen, collagen matrix, Phacotrabeculectomy, Aeon Astron, trabeculectomy, tissue engineering, mitomycin-C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
Other Intervention Name(s)
OculusGen (ologen™)
Intervention Description
Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery
Primary Outcome Measure Information:
Title
The primary endpoint is to prove the effectiveness via the reduction of IOP.
Time Frame
180 days
Secondary Outcome Measure Information:
Title
the secondary endpoint is to prove the safety via the reduction of complications.
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aung Tin, PhD MD
Phone
+65-62277255
Email
aung.tin@snec.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aung Tin, PhD MD
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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