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

October 6, 2011 updated by: Pro Top & Mediking Company Limited

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Qiang Wu, MD
  • Phone Number: 8367 +86 21-64369181

Study Locations

  • China
      • Shanghai, China, 200233
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
        • Principal Investigator:
          • Qiang Wu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Oculusgen™ (ologen™)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
Time Frame: 180 day
180 day

Secondary Outcome Measures

Outcome Measure
Time Frame
the safety via the incidence of complications and adverse events.
Time Frame: 180 day
180 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pro Top & Mediking Company Limited

Investigators

  • Principal Investigator: Qiang Wu, MD, Shanghai 6th People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (ANTICIPATED)

October 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (ESTIMATE)

May 25, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2011

Last Update Submitted That Met QC Criteria

October 6, 2011

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mediking 0705
  • Mediking 0503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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