Clinical trial NCT01915706: The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
Official title: The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma drainage device
Baerveldt 350
Ripcord
Complications
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Incidence of post-operative complications
timeFrame: Up to 6 months
Secondary outcomes:
measure: Incidence of successful intraocular pressure control
timeFrame: Post-operative month 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Leon Herndon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: An SJ, Wen JC, Quist MS, Mathenge EW, Vin A, Herndon LW. Scheduled Postoperative Ripcord Removal in Baerveldt 350 Implants: A Prospective, Randomized Trial. J Glaucoma. 2019 Feb;28(2):165-171. doi: 10.1097/IJG.0000000000001133.