The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
|ClinicalTrials.gov Identifier: NCT01915706|
Recruitment Status : Completed
First Posted : August 5, 2013
Last Update Posted : March 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Procedure: Ripcord removal||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||September 19, 2017|
|Actual Study Completion Date :||September 19, 2017|
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.
- Incidence of post-operative complications [ Time Frame: Up to 6 months ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915706
|United States, North Carolina|
|Duke Eye Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Leon Herndon, M.D.||Duke University|