Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.
Full 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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
18 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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