MedDataX Logo

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

NCT ID: NCT00478790

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glaucomas Pterygium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

ologen™ Collagen matrix implantation in glaucoma filtering surgery

Intervention Type DEVICE

ologen™ treatment is used, the collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Oculusgen™ (ologen™)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pro Top & Mediking Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qiang Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai sixth People's Hospital

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Qiang Wu, MD

Role: CONTACT

+86 21-64369181 ext. 8367

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Qiang Wu, MD

Role: primary

[email protected]
+86 21-64369181 ext. 8367

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 10937547 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mediking 0503

Identifier Type: -

Identifier Source: secondary_id

Mediking 0705

Identifier Type: -

Identifier Source: org_study_id