Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
Recruitment status was Recruiting
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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 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: | Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery |
- the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [ Time Frame: 180 day ] [ Designated as safety issue: No ]
- the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2007 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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.
Other Name: Oculusgen™ (ologen™)
|
Detailed Description:
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:
- Age 18 years or over
- Patient able to cooperate with study procedures and able to perform tests reliably
- Patient willing to sign informed consent
- Patient able and willing to complete postoperative follow-up requirements
- Glaucoma：one/both eyes are affected by glaucoma
- Pterygium： patient with pterygium
Exclusion Criteria:
- Known allergic reactions to collagen
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
Additional Information:
Publications:
| Responsible Party: | Pro Top & Mediking Company Limited |
| ClinicalTrials.gov Identifier: | NCT00478790 History of Changes |
| Other Study ID Numbers: | Mediking 0705, Mediking 0503 |
| Study First Received: | May 24, 2007 |
| Last Updated: | October 6, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Pro Top & Mediking Company Limited:
|
Glaucoma Pterygium collagen matrix OculusGen trabeculectomy |
Anti scarring pterygium recurrence tissue engineering ologen Aeon Astron |
Additional relevant MeSH terms:
|
Glaucoma Pterygium Ocular Hypertension Eye Diseases Conjunctival Diseases |
ClinicalTrials.gov processed this record on June 17, 2013