NCT04468633

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

December 17, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

September 5, 2024

Completed
Last Updated

September 5, 2024

Status Verified

August 1, 2024

Enrollment Period

2.5 years

First QC Date

July 9, 2020

Results QC Date

June 24, 2024

Last Update Submit

August 30, 2024

Conditions

Glaucoma

Keywords

Baerveldt 350 implantAhmed ClearPath implant

Outcome Measures

Primary Outcomes (2)

  • Intraocular Pressure (IOP)

    Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  • Number of Participants Who Experienced a Complication

    Up to Year 1

Secondary Outcomes (5)

  • Best Corrected Visual Acuity (BCVA)

    Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  • 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

  • Change in Humphrey Visual Field (HVF)

    Baseline and Year 1

  • Change in Thickness of the Cornea as Measured by Pachymetry

    Baseline and Year 1

  • Change in Retinal Nerve Fiber Layer (RNFL)

    Baseline and Year 1

Other Outcomes (8)

  • Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire

    Year 1

  • Quality of Life, as Measured by Glaucoma Symptom Scale

    Year 1

  • Quality of Life, as Measured by Glaucoma Utility Index

    Year 1

  • +5 more other outcomes

Study Arms (2)

Baerveldt 350 implant

ACTIVE COMPARATOR
Device: Baerveldt 350 implant

Ahmed ClearPath 350 implant

ACTIVE COMPARATOR
Device: Ahmed ClearPath 350 implant

Interventions

Baerveldt 350 implantDEVICE

The Baerveldt implant is an FDA-approved silicone, non-valved implant.

Baerveldt 350 implant
Ahmed ClearPath 350 implantDEVICE

The Ahmed ClearPath is a non-valved glaucoma drainage device.

Ahmed ClearPath 350 implant

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Results Point of Contact

Title
Andrew Gross, MD
Organization
Duke University
andrew.gross@duke.edu
919-684-8656

Study Officials

  • Leon Herndon, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 13, 2020

Study Start

December 17, 2020

Primary Completion

June 29, 2023

Study Completion

June 29, 2023

Last Updated

September 5, 2024

Results First Posted

September 5, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)