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

Phase 4TerminatedNCT02681419

The University of Texas Health Science Center, Houston18 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma

Interventions

Needle fenestrationPROCEDURE

This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature

Suture wickPROCEDURE

This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Robert Cizik Eye Clinic

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of participants with successful control of intraocular pressure

Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications within 3 weeks postop.

Time frame: 3 weeks

Secondary Outcomes

Duration of effect on intraocular pressure control

The duration of effect is defined as elapsed time from surgery to the time that intraocular pressure (IOP) \>5 mmHg or \<21 mmHg

Time frame: 12 weeks

Peri-fenestration bleb volume prior to tube opening

Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)

Time frame: 3 weeks

Peri-fenestration bleb volume after the tube has opened

Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)

Time frame: 12 weeks

Intraocular pressure after the tube has opened

Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications at 12 weeks postop

Time frame: 12 weeks

Data from ClinicalTrials.gov

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