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Completed

NCT Number: NCT00320957

Ologen (OculusGen)-Glaucoma and Pterygium Historical Control Study in China Zhong-Shan Hospital

The purpose of this study is to determine whether the OculusGen Collagen Matrix are effective and safe to implant as an aid of glaucoma surgery.

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Key information

Conditions

Glaucomas Conjunctival Diseases Eye Diseases Glaucoma Ocular Hypertension Pterygium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Zhongshan Hospital Fudan University

Shanghai, 200032, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OculusGen Biodegradable Collagen Matrix Implant

Device

Primary outcomes

  1. the effectiveness via the reduction of IOP and the incidence of pterygium recurrence

    Time frame: 180 day

Secondary outcomes

  1. the safety via the incidence of complications and adverse events.

    Time frame: 180 day

Sponsors and collaborators

Lead sponsor

Pro Top & Mediking Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2006
First posted
May 3, 2006
Registry last updated
May 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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