Oculusgen (Ologen) Collagen Matrix Implant for Phaco-Trabeculectomy in Primary Glaucoma: A Case-Control Study

NCT00687791 | Unknown Phase 3 DMC

• 1 other identifier: Mediking 0706
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the safety and effectiveness of the OculusGen™ (ologen) Biodegradable Collagen Matrix Implant in hacotrabeculectomy surgery. The primary endpoint is to prove the effectiveness via the reduction of IOP, and the secondary endpoint is to prove the safety via the incidence of complications and adverse events.

Conditions

Cataract; Glaucoma

Keywords

patients with cataract and glaucoma; ologen; oculusgen; collagen matrix; Phacotrabeculectomy; Aeon Astron; trabeculectomy; tissue engineering; mitomycin-C

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is to prove the effectiveness via the reduction of IOP.

  180 days

Secondary Outcomes (1)

• the secondary endpoint is to prove the safety via the reduction of complications.

  180 days

Study Arms (1)

1

EXPERIMENTAL

20 enrolled patients will be chosen according to the enrollment acceptance criteria. The evidence for the determination of enrolled patients shall be recorded, reviewed and approved. 2\> Phacotrabeculectomy is performed.3\> After completing phacotrabeculectomy, implant/place ologen™ Collagen Matrix on top of the scleral flap under the conjunctiva. For every inspection and observation, the detailed description and/or inspection data shall be recorded. If any unwanted adverse event is observed during inspection and observation, it shall be recorded and be reported to the investigation conductor.

Device: ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Interventions

ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery DEVICE

Study of the safety and effectiveness of the ologen™ Collagen Matrix Implant as an aid in phacotrabeculectomy surgery

Also known as: OculusGen (ologen™)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or over.
• At least one eye diagnosed with glaucoma and receiving maximally tolerated medical therapy.
• Visually significant cataract with visual acuity of less than or equal to 6/12.
• Subject able and willing to cooperate with investigation plan.
• Subject willing to sign informed consent form.

You may not qualify if:

• Known allergic reaction to collagen.
• Subject is on Warfarin and discontinuation is not recommended.
• Subject with normal tension glaucoma or aphakic glaucoma.
• Subject with corneal disease.
• Participation in an investigational study during the 30 days proceeding phacotrabeculectomy.
• Ocular infection within 14 days prior to phacotrabeculectomy.
• Pregnant or breast-feeding women.
• Monocular subject.

Sponsors & Collaborators

• Pro Top & Mediking Company Limited: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, 168751, Singapore

RECRUITING

MeSH Terms

Conditions

Cataract; Glaucoma

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• Aung Tin, PhD MD

  Singapore Eye Research Institute

  STUDY CHAIR

Central Study Contacts

Aung Tin, PhD MD

CONTACT

+65-62277255; aung.tin@snec.com.sg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 18, 2008

Record last verified: 2008-06

Locations

SG (1)