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

Study Overview
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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.

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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: Needle fenestration
* Procedure: Suture wick


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle fenestration<br>Needle fenestration | Procedure: Needle fenestration<br>* This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature<br>|
| Active Comparator: Suture wick<br>suture wick using 10-0 vicryl | Procedure: Suture wick<br>* This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Peri-fenestration bleb volume prior to tube opening | Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT) | 3 weeks | 
| Peri-fenestration bleb volume after the tube has opened | Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT) | 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 | 12 weeks |