OculusGen™ Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: a Case-Control Study
|First Received Date ICMJE||December 4, 2009|
|Last Updated Date||December 4, 2009|
|Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To assess the safety and effectiveness of the OculusGenTM Biodegradable Collagen Matrix Implant in Phaco-Trabeculectomy surgeries in patients with Primary Glaucoma [ Designated as safety issue: Yes ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||OculusGen™ Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: a Case-Control Study|
|Official Title ICMJE||Not Provided|
Frequently glaucoma is not controlled with clinical treatment ("eyedrops") or laser surgery to control your eye pressure. If this raised pressure is sustained over a long period of time it can lead to permanent damage to the optic nerve (glaucoma) and in severe cases it can result in blindness. You also have cataracts, an opacification of the natural lens inside the eye that is impairing your vision. To prevent further vision loss due to glaucoma, your doctor has recommended glaucoma filtration surgery to lower your eye pressure, and cataract surgery at the same time to improve your sight.
The use of the anti-metabolite (Mitomycin-C) during the operation is currently the drug of choice to improve surgical outcome for glaucoma filtration surgery. Mitomycin-C is a potent antiscarring agent that reduces the amount of scar tissue produced after surgery which leads to better control of eye pressure. Although this potent drug is effective in increasing surgical success, its use is related to a higher risk of post surgical complications, some of which are sight threatening.
The Collagen Matrix Implant is a biodegradable implant (absorbed naturally by tissue), made from porcine collagen, which reduces scar tissue formed after glaucoma filtration surgery without the use of Mitomycin-C. This means that you could be less likely to have a failed glaucoma filtration surgery, and consequently, a poor eye pressure control. In addition, the risk of surgical failure may be reduced because with this technique, we will not be using potent drugs. However, the long-term effect of the OculusGenTm implant in glaucoma filtration surgery is not fully known.
The aim of the study is to determine whether the OculusGenTm implant can equal the success rate of Mitomycin-C in controlling eye pressure, without the potentially sight threatening complications associated with Mitomycin use. And at the same time, this study aim to determine if the implant can reduce potential complications related to glaucoma surgery when compared to the combined surgery augmented with anti-proliferative agents.
This study will recruit 66 subjects from patients attending the Singapore National Eye Centre over a period of 12-24 months.
|Detailed Description||Not Provided|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Not Provided|
|Intervention ICMJE||Device: Ologen TM|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||21 Years to 85 Years|
|Accepts Healthy Volunteers||Not Provided|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Not Provided|
|NCT Number ICMJE||NCT01027247|
|Other Study ID Numbers ICMJE||R539/27/2007|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Singapore National Eye Centre|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||Singapore National Eye Centre|
|Verification Date||December 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP