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

Completed · Not applicable

Conditions studied: Glaucoma

In brief

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.

Key facts

Study ID

NCT01915706

Run by

Duke University

People needed

81

Starts

2013-09-01

Expected to finish

2017-09-19

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke Eye Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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