The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants|
- Incidence of post-operative complications [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]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.
- Incidence of successful intraocular pressure control [ Time Frame: Post-operative month 6 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
No Intervention: Observation
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.
Experimental: Ripcord removal
Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.
Procedure: Ripcord removal
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915706
|Contact: Leon Herndon, M.D.||(919) firstname.lastname@example.org|
|United States, North Carolina|
|Duke Eye Center||Recruiting|
|Durham, North Carolina, United States, 27710|
|Principal Investigator: Leon Herndon, M.D.|
|Principal Investigator:||Leon Herndon, M.D.||Duke University|