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The Baerveldt Versus ClearPath Comparison Study

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Baerveldt 350 implant
Ahmed ClearPath 350 implant
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Baerveldt 350 implant, Ahmed ClearPath implant

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Baerveldt 350 implant

Ahmed ClearPath 350 implant

Arm Description

Outcomes

Primary Outcome Measures

Change in intraocular pressure (IOP)
Complication rate
Complication rate
Complication rate
Complication rate
Complication rate
Complication rate
Complication rate
Complication rate

Secondary Outcome Measures

Change in Best corrected visual acuity (BCVA)
Change in number of individual eyedrop medications that the patient is on (prescribed and actually taking)
Change in Slit lamp exam (SLE) findings
Change in Dilated fundus exam (DFE)
Change in Humphrey visual field (HVF)
Change in Ocular coherence tomography (OCT)
Change in Pachymetry
Change in Motility exam (9 gaze photos)
Change in Motility exam (stereo test)
If patient is binocular
Change in Motility exam (Worth 4-dot)
If patient is binocular
Change in Motility exam (Hess Screen Test)
If patient is binocular
Change in Self-report Dysesthesia Scale questionnaire
Quality of life, as measured by glaucoma utility index
Quality of life, as measured by glaucoma symptom scale
Quality of life, as measured by glaucoma related quality of life 15 questionnaire

Full Information

First Posted
July 9, 2020
Last Updated
August 3, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04468633
Brief Title
The Baerveldt Versus ClearPath Comparison Study
Official Title
The Baerveldt Versus ClearPath Comparison Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
June 29, 2023 (Actual)
Study Completion Date
June 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Baerveldt 350 implant, Ahmed ClearPath implant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Baerveldt 350 implant
Arm Type
Active Comparator
Arm Title
Ahmed ClearPath 350 implant
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Baerveldt 350 implant
Intervention Description
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
Intervention Type
Device
Intervention Name(s)
Ahmed ClearPath 350 implant
Intervention Description
The Ahmed ClearPath is a non-valved glaucoma drainage device.
Primary Outcome Measure Information:
Title
Change in intraocular pressure (IOP)
Time Frame
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Title
Complication rate
Time Frame
Baseline
Title
Complication rate
Time Frame
Day 1
Title
Complication rate
Time Frame
Week 1
Title
Complication rate
Time Frame
Week 4
Title
Complication rate
Time Frame
Week 6
Title
Complication rate
Time Frame
Month 3
Title
Complication rate
Time Frame
Month 6
Title
Complication rate
Time Frame
Year 1
Secondary Outcome Measure Information:
Title
Change in Best corrected visual acuity (BCVA)
Time Frame
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Title
Change in number of individual eyedrop medications that the patient is on (prescribed and actually taking)
Time Frame
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Title
Change in Slit lamp exam (SLE) findings
Time Frame
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Title
Change in Dilated fundus exam (DFE)
Time Frame
Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Title
Change in Humphrey visual field (HVF)
Time Frame
Baseline and Year 1
Title
Change in Ocular coherence tomography (OCT)
Time Frame
Baseline and Year 1
Title
Change in Pachymetry
Time Frame
Baseline and Year 1
Title
Change in Motility exam (9 gaze photos)
Time Frame
Baseline and Year 1
Title
Change in Motility exam (stereo test)
Description
If patient is binocular
Time Frame
Baseline and Year 1
Title
Change in Motility exam (Worth 4-dot)
Description
If patient is binocular
Time Frame
Baseline and Year 1
Title
Change in Motility exam (Hess Screen Test)
Description
If patient is binocular
Time Frame
Baseline and Year 1
Title
Change in Self-report Dysesthesia Scale questionnaire
Time Frame
Baseline and Year 1
Title
Quality of life, as measured by glaucoma utility index
Time Frame
Year 1
Title
Quality of life, as measured by glaucoma symptom scale
Time Frame
Year 1
Title
Quality of life, as measured by glaucoma related quality of life 15 questionnaire
Time Frame
Year 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Herndon, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Baerveldt Versus ClearPath Comparison Study

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