Glaucoma
Conditions
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.
Interventions
PROCEDURENeedle fenestration
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
PROCEDURESuture wick
This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
Sponsors
Robert Cizik Eye Clinic
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with successful control of intraocular pressure | 3 weeks | Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications within 3 weeks postop. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of effect on intraocular pressure control | 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 |
| Peri-fenestration bleb volume prior to tube opening | 3 weeks | Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT) |
| Peri-fenestration bleb volume after the tube has opened | 12 weeks | Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT) |
| Intraocular pressure after the tube has opened | 12 weeks | Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications at 12 weeks postop |
Countries
United States
Outcome results
None listed