search
Back to results

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

Primary Purpose

Glaucomas, Pterygium

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
ologen™ Collagen matrix implantation in glaucoma filtering surgery
Sponsored by
Pro Top & Mediking Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucomas focused on measuring Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, ologen, Aeon Astron

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shanghai sixth People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the safety via the incidence of complications and adverse events.

Full Information

First Posted
May 24, 2007
Last Updated
October 6, 2011
Sponsor
Pro Top & Mediking Company Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT00478790
Brief Title
Ologen(Oculusgen)-Glaucoma and Pterygium Historical Control Study in China Shanghai Sixth People's Hospital
Official Title
Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pro Top & Mediking Company Limited

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucomas, Pterygium
Keywords
Glaucoma, Pterygium, collagen matrix, OculusGen, trabeculectomy, Anti scarring, pterygium recurrence, tissue engineering, ologen, Aeon Astron

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Intervention Type
Device
Intervention Name(s)
ologen™ Collagen matrix implantation in glaucoma filtering surgery
Other Intervention Name(s)
Oculusgen™ (ologen™)
Intervention Description
ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
Primary Outcome Measure Information:
Title
the effectiveness via the reduction of IOP and the incidence of pterygium recurrence
Time Frame
180 day
Secondary Outcome Measure Information:
Title
the safety via the incidence of complications and adverse events.
Time Frame
180 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Wu, MD
Phone
+86 21-64369181
Ext
8367
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiang Wu, MD
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai sixth People's Hospital
City
Shanghai
ZIP/Postal Code
200233
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiang Wu, MD
Phone
+86 21-64369181
Ext
8367
Email
wyan559@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qiang Wu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10937547
Citation
Hsu WC, Spilker MH, Yannas IV, Rubin PA. Inhibition of conjunctival scarring and contraction by a porous collagen-glycosaminoglycan implant. Invest Ophthalmol Vis Sci. 2000 Aug;41(9):2404-11.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs