Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period

Phase 4

Terminated

• Conditions: Glaucoma
• Interventions: Procedure: Needle fenestration; Procedure: Suture wick

• Registration Number: NCT02681419
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.

Detailed Description

This is a prospective, randomized control study of glaucomatous eye undergoing tube shunt implantation using a nonvalved implant for poorly controlled glaucoma of any type. Eyes scheduled to receive a nonvalved tube shunt implant will be randomized to receive either needle fenestration(s) or a suture wick using a single 10-0 vicryl anterior to the ligature. The operative quadrant will be imaged using anterior-segment optical coherence tomography at pre- and post-operative visits.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Primary Completion: 2017-03-17
• Study Completion: 2017-03-17
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 18 years of age or older
• Eyes that have poorly controlled glaucoma requiring a tube shunt implantation
• Willingness to participate in the study and sign informed consent

Exclusion Criteria

• Concurrent surgery except phaco/intraocular lens
• Any abnormality preventing reliable applanation tonometry
• Eyes with exposure limitation (tight lids, deep orbits) that would make performing the anterior segment optical coherence tomography difficult

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Needle fenestration	Needle fenestration	Needle fenestration
Suture wick	Suture wick	suture wick using 10-0 vicryl

Primary Outcome Measures

Name	Time	Method
Number of participants with successful control of intraocular pressure	3 weeks	Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications within 3 weeks postop.

Secondary Outcome Measures

Name	Time	Method
Duration of effect on intraocular pressure control	12 weeks	The duration of effect is defined as elapsed time from surgery to the time that intraocular pressure (IOP) \>5 mmHg or \<21 mmHg
Peri-fenestration bleb volume prior to tube opening	3 weeks	Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Peri-fenestration bleb volume after the tube has opened	12 weeks	Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Intraocular pressure after the tube has opened	12 weeks	Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications at 12 weeks postop

Trial Locations

Locations (1)

Robert Cizik Eye Clinic; 🇺🇸 Houston, Texas, United States