Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period

Glaucoma Clinical Trial

Official title:

Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02681419
• Other study ID #: HSC-MS-12-0800
• Status: Terminated
• Phase: Phase 4
• First received: February 9, 2016
• Last updated: January 31, 2018
• Start date: January 2013
• Est. completion date: March 17, 2017

Study information

• Verified date: January 2018
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 17, 2017
• Est. primary completion date: March 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Needle fenestration
This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
• Suture wick
This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature

Locations

Country	Name	City	State
United States	Robert Cizik Eye Clinic	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Robert Cizik Eye Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Peri-fenestration bleb volume prior to tube opening	Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)	3 weeks
Secondary	Peri-fenestration bleb volume after the tube has opened	Bleb volume will be measured by the anterior segment optical coherence tomography (ASOCT)	12 weeks
Secondary	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