The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|