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The Baerveldt Versus ClearPath Comparison Study

Sponsor
Duke University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04468633
Collaborator
(none)
76
Enrollment
1
Location
2
Arms
28.4
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.

Condition or Disease Intervention/Treatment Phase
  • Device: Baerveldt 350 implant
  • Device: Ahmed ClearPath 350 implant
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
76 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
The Baerveldt Versus ClearPath Comparison Study
Actual Study Start Date :
Dec 17, 2020
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Baerveldt 350 implant

Device: Baerveldt 350 implant
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Active Comparator: Ahmed ClearPath 350 implant

Device: Ahmed ClearPath 350 implant
The Ahmed ClearPath is a non-valved glaucoma drainage device.

Outcome Measures

Primary Outcome Measures

  1. Change in intraocular pressure (IOP) [Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1]

  2. Complication rate [Baseline]

  3. Complication rate [Day 1]

  4. Complication rate [Week 1]

  5. Complication rate [Week 4]

  6. Complication rate [Week 6]

  7. Complication rate [Month 3]

  8. Complication rate [Month 6]

  9. Complication rate [Year 1]

Secondary Outcome Measures

  1. Change in Best corrected visual acuity (BCVA) [Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1]

  2. Change in number of individual eyedrop medications that the patient is on (prescribed and actually taking) [Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1]

  3. Change in Slit lamp exam (SLE) findings [Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1]

  4. Change in Dilated fundus exam (DFE) [Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1]

  5. Change in Humphrey visual field (HVF) [Baseline and Year 1]

  6. Change in Ocular coherence tomography (OCT) [Baseline and Year 1]

  7. Change in Pachymetry [Baseline and Year 1]

  8. Change in Motility exam (9 gaze photos) [Baseline and Year 1]

  9. Change in Motility exam (stereo test) [Baseline and Year 1]

    If patient is binocular

  10. Change in Motility exam (Worth 4-dot) [Baseline and Year 1]

    If patient is binocular

  11. Change in Motility exam (Hess Screen Test) [Baseline and Year 1]

    If patient is binocular

  12. Change in Self-report Dysesthesia Scale questionnaire [Baseline and Year 1]

  13. Quality of life, as measured by glaucoma utility index [Year 1]

  14. Quality of life, as measured by glaucoma symptom scale [Year 1]

  15. Quality of life, as measured by glaucoma related quality of life 15 questionnaire [Year 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Men or women with age at screening ≥ 18 years and ≤ 90 years

  • Inadequately controlled glaucoma

  • Valve-less aqueous shunt as the planned surgical procedure

  • Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.

  • Primary tubes included

  • Investigators to recruit consecutively all eligible patients from their clinics.

  • Superotemporal or inferonasal placement of the tube

  • Capable and willing to provide consent

Exclusion Criteria:

  • NLP

  • Unable/unwilling to provide informed consent

  • Unavailable for regular follow up

  • Previous cyclodestructive procedure

  • Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation

  • Presence of silicone oil

  • Vitreous in the anterior chamber sufficient to require a vitrectomy

  • Uveitic glaucoma

  • Neovascular glaucoma

  • Nanophthalmos

  • Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure

  • Procedure combined with other surgery

  • Any abnormality other than glaucoma in the study eye that could affect tonometry.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Eye Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Leon Herndon, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04468633
Other Study ID Numbers:
  • PRO00105781
First Posted:
Jul 13, 2020
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Duke University
Baerveldt 350 implant
Ahmed ClearPath implant
Additional relevant MeSH terms:
Glaucoma

Study Results

No Results Posted as of Jul 14, 2022