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Completed

NCT Number: NCT04468633

The Baerveldt Versus ClearPath Comparison Study

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Baerveldt 350 implant

Device

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

Ahmed ClearPath 350 implant

Device

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

Primary outcomes

  1. Intraocular Pressure (IOP)

    Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  2. Number of Participants Who Experienced a Complication

    Time frame: Up to Year 1

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1

  2. 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

  3. Change in Humphrey Visual Field (HVF)

    Time frame: Baseline and Year 1

    The Humphrey visual field test measures the entire area of peripheral vision that can be seen while the eye is focused on a central point. A positive value indicates an increase in visual field while a negative value indicates a decrease.

  4. Change in Thickness of the Cornea as Measured by Pachymetry

    Time frame: Baseline and Year 1

    Pachymetry is an ophthalmological test that measures the thickness of the cornea.

  5. Change in Retinal Nerve Fiber Layer (RNFL)

    Time frame: Baseline and Year 1

    The retinal nerve fiber layer (RNFL) is formed by retinal ganglion cell axons, which collect the visual impulses that begin with the rods and cones.

Other outcomes

  1. Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire

    Time frame: Year 1

  2. Quality of Life, as Measured by Glaucoma Symptom Scale

    Time frame: Year 1

  3. Quality of Life, as Measured by Glaucoma Utility Index

    Time frame: Year 1

  4. Change in Self-report Dysesthesia Scale Questionnaire

    Time frame: Baseline and Year 1

  5. Change in Motility Exam (Hess Screen Test)

    Time frame: Baseline and Year 1

    If patient is binocular

  6. Change in Motility Exam (Worth 4-dot)

    Time frame: Baseline and Year 1

    If patient is binocular

  7. Change in Motility Exam (Stereo Test)

    Time frame: Baseline and Year 1

    If patient is binocular

  8. Change in Motility Exam (9 Gaze Photos)

    Time frame: Baseline and Year 1

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2020
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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