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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Pro Top & Mediking Company Limited.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier:
NCT00478790
First received: May 24, 2007
Last updated: October 6, 2011
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Glaucomas
Pterygium
Device: ologen™ Collagen matrix implantation in glaucoma filtering surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Safety and Effectiveness of the Ologen(OculusGen) Collagen Matrix Implant as an Aid in Glaucoma and Pterygium Surgery

Resource links provided by NLM:


Further study details as provided by Pro Top & Mediking Company Limited:

Primary Outcome Measures:
  • the effectiveness via the reduction of IOP and the incidence of pterygium recurrence [ Time Frame: 180 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the safety via the incidence of complications and adverse events. [ Time Frame: 180 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oculusgen™ (ologen™)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478790

Contacts
Contact: Qiang Wu, MD +86 21-64369181 ext 8367

Locations
China
Shanghai sixth People's Hospital Recruiting
Shanghai, China, 200233
Contact: Qiang Wu, MD    +86 21-64369181 ext 8367    wyan559@hotmail.com   
Principal Investigator: Qiang Wu, MD         
Sponsors and Collaborators
Pro Top & Mediking Company Limited
Investigators
Principal Investigator: Qiang Wu, MD Shanghai Sixth People's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Pro Top & Mediking Company Limited
ClinicalTrials.gov Identifier: NCT00478790     History of Changes
Other Study ID Numbers: Mediking 0705, Mediking 0503
Study First Received: May 24, 2007
Last Updated: October 6, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Pro Top & Mediking Company Limited:
Glaucoma
Pterygium
collagen matrix
OculusGen
trabeculectomy
Anti scarring
pterygium recurrence
tissue engineering
ologen
Aeon Astron

Additional relevant MeSH terms:
Glaucoma
Pterygium
Ocular Hypertension
Eye Diseases
Conjunctival Diseases

ClinicalTrials.gov processed this record on July 22, 2014