Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital

Pro Top & Mediking

Status and phase: Unknown; Phase 3

Conditions: Pterygium; Glaucomas

Treatments: Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478790

Mediking 0503

Mediking 0705

Details and patient eligibility

About

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.

Full 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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery