Status:
COMPLETED
The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
Lead Sponsor:
Duke University
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
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-oper...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2017
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT01915706
Start Date
September 1 2013
End Date
September 19 2017
Last Update
March 1 2018
Active Locations (1)
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1
Duke Eye Center
Durham, North Carolina, United States, 27710