Trabeculectomy With Ologen

Glaucoma Clinical Trial

Official title:

Trabeculectomy With Ologen-Pilot

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01753492
• Other study ID #: NL42312.068.12/METC12-2-073
• Status: Terminated
• Phase: N/A
• First received: December 12, 2012
• Last updated: May 22, 2015
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.

Recently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.

This is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.

The study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: March 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.

• Indication for trabeculectomy with mitomycin-C

Exclusion Criteria:

• Unability to discontinue oral anticoagulants

• Difficulty in reading or speaking Dutch

• Previous ocular surgery (cataract surgery allowed)

• Pregnant and breastfeeding women

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Ologen

Locations

Country	Name	City	State
Netherlands	University Eye Clinic	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Aeon Astron Europe B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)		3 months	No
Other	surgery time		3 months	No
Other	complexity of surgical procedure		3 months	No
Other	number of patients withdrawn from study because of failure		3 months	No
Primary	Postoperative intraocular pressure level		3 months	No
Secondary	Number of glaucoma medications		3 months	No