The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants

This study is currently recruiting participants.
Verified February 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01915706
First received: July 31, 2013
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Glaucoma
Procedure: Ripcord removal

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915706

Contacts
Contact: Leon Herndon, M.D. (919) 684-6622 leon.herndon@duke.edu

Locations
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Principal Investigator: Leon Herndon, M.D.         
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Leon Herndon, M.D. Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01915706     History of Changes
Other Study ID Numbers: Pro00047845
Study First Received: July 31, 2013
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Glaucoma drainage device
Baerveldt 350
Ripcord
Complications

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014