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

Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00478790

Enrollment

Registered

2007-05-25

Start date

2007-02-28

Completion date

2011-10-31

Last updated

2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucomas, Pterygium

Keywords

Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, ologen, Aeon Astron

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).

Interventions

DEVICEologen™ 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence	180 day

Secondary

Measure	Time frame
the safety via the incidence of complications and adverse events.	180 day

Countries

China

Contacts

Primary ContactQiang Wu, MD

+86 21-64369181

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026