The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants

Not Applicable

Completed

• Conditions: Glaucoma
• Interventions: Procedure: Ripcord removal

• Registration Number: NCT01915706
• Lead Sponsor: Duke University

Brief Summary

The purpose of this study is to compare the post-operative complication rates and surgical outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350 implant will be recruited and randomized at the time of enrollment to either scheduled ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications will be documented and compared between the 2 groups. The final intraocular pressure control between the 2 groups will also be compared in a secondary outcome analysis. This study will help to establish post-operative management guidelines to minimize complications and improve intraocular pressure lowering success following Baerveldt 350 implantation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-31
• Study First Submitted QC: 2013-08-01
• Study First Posted: 2013-08-05
• Study Start: 2013-09
• Primary Completion: 2017-09-19
• Study Completion: 2017-09-19
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Men or women aged 18 years and older at screening. There is no upper age limit.
• Inadequately controlled glaucoma refractory to maximum therapy
• Suitable candidate for Baerveldt-350 implant in the superotemporal quadrant in the study eye, which the physician deems as medically necessary.
• Capable and willing to provide consent

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Exclusion Criteria

• Unable or unwilling to provide consent
• Any previous ocular surgery other than cataract extraction or trabeculectomy
• Any previous ocular surgeries in the study eye preventing placement of the Baerveldt-350 implant in the superotemporal quadrant
• Any abnormality other than glaucoma in the study eye that could affect tonometry.
• Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
• Monocularity (where best corrected visual acuity in the non-operative eye is worse than 20/200)
• Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• Known pregnant or breastfeeding women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ripcord removal	Ripcord removal	Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.

Primary Outcome Measures

Name	Time	Method
Incidence of post-operative complications	Up to 6 months	Incidence of complications (including but not limited to shallowing of the anterior chamber, hypotony, choroidal effusion and choroidal hemorrhage) will be documented and compared between the 2 groups.

Secondary Outcome Measures

Name	Time	Method
Incidence of successful intraocular pressure control	Post-operative month 6	Final intraocular pressure at post-operative month 6 will be assessed and incidence of successful intraocular pressure control will be compared. Successful intraocular pressure control is defined as unqualified when the intraocular pressure is between 6 and 18 mmHg or a 25% reduction from the pre-surgical intraocular pressure without medication and qualified when pressure-lowering therapies are required to maintain intraocular pressure at that level.

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States