Back to resultsThe Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ripcord removal
Sponsored by
About this trial
This is an interventional prevention trial for Glaucoma focused on measuring Glaucoma drainage device, Baerveldt 350, Ripcord, Complications
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
Sites / Locations
- Duke Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Observation
Ripcord removal
Arm Description
Patients randomized to observation will be observed during the post-operative period for spontaneous Baerveldt-350 tube opening. The ripcord will not be removed unless deemed medically necessary by the study physician.
Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.
Outcomes
Primary Outcome Measures
Incidence of post-operative complications
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
Incidence of successful intraocular pressure control
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01915706
Brief Title
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
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
September 19, 2017 (Actual)
Study Completion Date
September 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma drainage device, Baerveldt 350, Ripcord, Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
No Intervention
Arm Description
Patients randomized to observation will be observed during the post-operative period for spontaneous Baerveldt-350 tube opening. The ripcord will not be removed unless deemed medically necessary by the study physician.
Arm Title
Ripcord removal
Arm Type
Experimental
Arm Description
Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.
Intervention Type
Procedure
Intervention Name(s)
Ripcord removal
Intervention Description
Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3. Ripcord removal will be performed by study PI at the slit lamp with standard of care sterile technique and topical/local anesthesia. Patients will be monitored 30 minutes following ripcord removal for intraocular pressure as well as complications.
Primary Outcome Measure Information:
Title
Incidence of post-operative complications
Description
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.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Incidence of successful intraocular pressure control
Description
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.
Time Frame
Post-operative month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Herndon, M.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30689608
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.
Results Reference
derived
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The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
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