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| Sponsored by: |
Pro Top & Mediking Company Limited |
|---|---|
| Information provided by: | Pro Top & Mediking Company Limited |
| ClinicalTrials.gov Identifier: | NCT00478790 |
Purpose
The purpose of this study is to determine whether the ologen (OculusGen) Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery and pterygium excision surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucomas Pterygium |
Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery |
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | June 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
ologen™ collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy. After operation with ologen™ Collagen Matrix, anti-inflammatory eye-drops will be prescribed
|
Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery
ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
|
ologen (OculusGen) Collagen Matrix is a porous, scaffold matrix. It is to be implanted on the top of the scleral flap and beneath the conjunctiva and Tenon's capsule at the end of trabeculectomy. The pores in the scaffold matrix range from 20 to 200µm, a size that is suitable for fibroblasts to grow randomly, through the body of the matrix without causing scarring. The space occupied by the collagen matrix scaffold creates room for the development of a filtration bleb. Immediately after implantation, the collagen matrix is absorbed with the aqueous humor that bring a certain pressure press on the top of scleral flap which makes the dynamic balance for the aqueous system to keep the IOP in the right side. The collagen matrix is bio-degraded within 90 days and will leave a physiologic space for the filtration bleb to facilitate control of intraocular pressure (IOP).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Qiang Wu, MD | +86 21-64369181 ext 8367 |
| China | |
| Shanghai sixth People's Hospital | Recruiting |
| Shanghai, China, 200233 | |
| Contact: Qiang Wu, MD +86 21-64369181 ext 8367 wyan559@hotmail.com | |
| Principal Investigator: Qiang Wu, MD | |
| Principal Investigator: | Qiang Wu, MD | Shanghai Sixth People's Hospital |
More Information
| Responsible Party: | Pro Top & Mediking Company Limited |
| Study ID Numbers: | Mediking 0705, Mediking 0503 |
| Study First Received: | May 24, 2007 |
| Last Updated: | June 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00478790 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
Glaucoma Pterygium collagen matrix OculusGen trabeculectomy |
Anti scarring pterygium recurrence tissue engineering ologen Aeon Astron |
|
Glaucoma Eye Diseases Pterygium of the Conjunctiva Pterygium Conjunctival Diseases |
Recurrence Hypertension Ocular Hypertension Cicatrix |
|
Glaucoma Eye Diseases Pterygium Conjunctival Diseases Ocular Hypertension |
