GlaucomaPhase 4NCT02681419
Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
A Phase 4 study testing Needle fenestration and Suture wick in people with Glaucoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Needle fenestration and Suture wick
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 17 Mar 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Needle fenestration, Suture wick
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle fenestrationProcedure or surgery
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
Suture wickProcedure or surgery
This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
| Study group | Role | What they receive |
|---|---|---|
| Needle fenestration | Active comparator | Needle fenestration Receives: Procedure: Needle fenestration |
| Suture wick | Active comparator | suture wick using 10-0 vicryl Receives: Procedure: Suture wick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (4)
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
Measured: 12 weeks
Peri-fenestration bleb volume prior to tube opening
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Measured: 3 weeks
Peri-fenestration bleb volume after the tube has opened
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2013
- Primary completion17 Mar 2017
- Study completion17 Mar 2017
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Responsible party
- Principal investigator, Robert Feldman, The University of Texas Health Science Center, Houston
- Investigators
- Lauren S. Blieden, MD, Principal investigator, Robert Cizik Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681419
- Sponsor's protocol ID
- HSC-MS-12-0800
- Status last verified
- Jan 2018
- First submitted
- 9 Feb 2016
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
- ClinicalTrials.gov ID
- NCT02681419
- Acronym / sponsor ID
- HSC-MS-12-0800
- Conditions
- Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Robert Cizik Eye Clinic
- Study start
- Jan 2013
- Primary completion
- 17 Mar 2017 (actual)
- Study completion
- 17 Mar 2017 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle fenestration | Active comparator | Procedure: Needle fenestrationNeedle fenestration |
| Suture wick | Active comparator | Procedure: Suture wicksuture wick using 10-0 vicryl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle fenestrationThis technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature | Procedure or surgery | Needle fenestration |
| Suture wickThis technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature | Procedure or surgery | Suture wick |
Primary outcome
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.
4 secondary outcomes
Duration of effect on intraocular pressure control
Time frame: 12 weeks
Peri-fenestration bleb volume prior to tube opening
Time frame: 3 weeks
Peri-fenestration bleb volume after the tube has opened
Time frame: 12 weeks
Intraocular pressure after the tube has opened
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren S. Blieden, MD principal investigator
Robert Cizik Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Needle fenestration and Suture wick in people with Glaucoma, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful control of intraocular pressure (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.