Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
- Conditions
- GlaucomasPterygium
- Interventions
- Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery
- Registration Number
- NCT00478790
- Lead Sponsor
- Pro Top & Mediking Company Limited
- Brief Summary
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.
- 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- Known allergic reactions to collagen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 ologen™ Collagen matrix implantation in glaucoma filtering surgery 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
- Primary Outcome Measures
Name Time Method the effectiveness via the reduction of IOP and the incidence of pterygium recurrence 180 day
- Secondary Outcome Measures
Name Time Method the safety via the incidence of complications and adverse events. 180 day
Trial Locations
- Locations (1)
Shanghai sixth People's Hospital
🇨🇳Shanghai, China