Cataract, Glaucoma
Conditions
Keywords
patients with cataract and glaucoma, ologen, oculusgen, collagen matrix, Phacotrabeculectomy, Aeon Astron, trabeculectomy, tissue engineering, mitomycin-C
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
Interventions
DEVICEologen™ 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
Sponsors
Pro Top & Mediking Company Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to prove the effectiveness via the reduction of IOP. | 180 days |
Secondary
| Measure | Time frame |
|---|---|
| the secondary endpoint is to prove the safety via the reduction of complications. | 180 days |
Countries
Singapore
Contacts
Primary ContactAung Tin, PhD MD
Outcome results
None listed