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

January 31, 2018 updated by: Robert Feldman, The University of Texas Health Science Center, Houston
This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Robert Cizik Eye Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Needle fenestration
Procedure: Needle fenestration
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
ACTIVE_COMPARATOR: Suture wick
suture wick using 10-0 vicryl
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with successful control of intraocular pressure
Time Frame: 3 weeks
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
Time Frame: 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
12 weeks
Peri-fenestration bleb volume prior to tube opening
Time Frame: 3 weeks
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
3 weeks
Peri-fenestration bleb volume after the tube has opened
Time Frame: 12 weeks
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
12 weeks
Intraocular pressure after the tube has opened
Time Frame: 12 weeks
Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications at 12 weeks postop
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Robert Cizik Eye Clinic

Investigators

  • Principal Investigator: Lauren S. Blieden, MD, Robert Cizik Eye Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

March 17, 2017

Study Completion (ACTUAL)

March 17, 2017

Study Registration Dates

First Submitted

February 9, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (ESTIMATE)

February 12, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-12-0800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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