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

Primary Purpose

Glaucoma

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Needle fenestration
Suture wick
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert Cizik Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Needle fenestration

Suture wick

Arm Description

Needle fenestration

suture wick using 10-0 vicryl

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Peri-fenestration bleb volume prior to tube opening
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Peri-fenestration bleb volume after the tube has opened
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
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

Full Information

First Posted
February 9, 2016
Last Updated
January 31, 2018
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Robert Cizik Eye Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02681419
Brief Title
Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
Official Title
Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
Investigator left institution
Study Start Date
January 2013 (undefined)
Primary Completion Date
March 17, 2017 (Actual)
Study Completion Date
March 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Robert Cizik Eye Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Needle fenestration
Arm Type
Active Comparator
Arm Description
Needle fenestration
Arm Title
Suture wick
Arm Type
Active Comparator
Arm Description
suture wick using 10-0 vicryl
Intervention Type
Procedure
Intervention Name(s)
Needle fenestration
Intervention Description
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
Intervention Type
Procedure
Intervention Name(s)
Suture wick
Intervention Description
This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
Primary Outcome Measure Information:
Title
Number of participants with successful control of intraocular pressure
Description
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 Outcome Measure Information:
Title
Duration of effect on intraocular pressure control
Description
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
Title
Peri-fenestration bleb volume prior to tube opening
Description
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Time Frame
3 weeks
Title
Peri-fenestration bleb volume after the tube has opened
Description
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Time Frame
12 weeks
Title
Intraocular pressure after the tube has opened
Description
Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications at 12 weeks postop
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren S. Blieden, MD
Organizational Affiliation
Robert Cizik Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Cizik Eye Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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