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

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

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-03-17

Brief Summary

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

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Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Needle fenestration

Group Type ACTIVE_COMPARATOR

Needle fenestration

Intervention Type PROCEDURE

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

Suture wick

suture wick using 10-0 vicryl

Group Type ACTIVE_COMPARATOR

Suture wick

Intervention Type PROCEDURE

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

Interventions

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Needle fenestration

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

Intervention Type PROCEDURE

Suture wick

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No