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| Name | Class |
|---|---|
| Robert Cizik Eye Clinic | OTHER |
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This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Needle fenestration | Active Comparator | Needle fenestration |
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| Suture wick | Active Comparator | suture wick using 10-0 vicryl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Needle fenestration | Procedure | This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Peri-fenestration bleb volume prior to tube opening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren S. Blieden, MD | Robert Cizik Eye Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Cizik Eye Clinic | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Suture wick | Procedure | This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature |
|
Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)
| 3 weeks |
| Peri-fenestration bleb volume after the tube has opened | Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT) | 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 | 12 weeks |