Study Stopped
Investigator left institution
Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 9, 2016
CompletedFirst Posted
Study publicly available on registry
February 12, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2017
CompletedFebruary 5, 2018
January 1, 2018
4.2 years
February 9, 2016
January 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Duration of effect on intraocular pressure control
12 weeks
Peri-fenestration bleb volume prior to tube opening
3 weeks
Peri-fenestration bleb volume after the tube has opened
12 weeks
Intraocular pressure after the tube has opened
12 weeks
Study Arms (2)
Needle fenestration
ACTIVE COMPARATORNeedle fenestration
Suture wick
ACTIVE COMPARATORsuture wick using 10-0 vicryl
Interventions
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Robert Cizik Eye Clinic
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lauren S. Blieden, MD
Robert Cizik Eye Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department Chair
Study Record Dates
First Submitted
February 9, 2016
First Posted
February 12, 2016
Study Start
January 1, 2013
Primary Completion
March 17, 2017
Study Completion
March 17, 2017
Last Updated
February 5, 2018
Record last verified: 2018-01
Data Sharing
- IPD Sharing
- Will not share