Clinical trial NCT04468633: The Baerveldt Versus ClearPath Comparison Study
Official title: The Baerveldt Versus ClearPath Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Baerveldt 350 implant
Ahmed ClearPath implant
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-07-13
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Number of Participants Who Experienced a Complication
timeFrame: Up to Year 1
Secondary outcomes:
measure: Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)
timeFrame: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
measure: Change in Humphrey Visual Field (HVF)
timeFrame: Baseline and Year 1
measure: Change in Thickness of the Cornea as Measured by Pachymetry
timeFrame: Baseline and Year 1
measure: Change in Retinal Nerve Fiber Layer (RNFL)
timeFrame: Baseline and Year 1
Other outcomes:
measure: Quality of Life, as Measured by Glaucoma Related Quality of Life 15 Questionnaire
timeFrame: Year 1
measure: Quality of Life, as Measured by Glaucoma Symptom Scale
timeFrame: Year 1
measure: Quality of Life, as Measured by Glaucoma Utility Index
timeFrame: Year 1
measure: Change in Self-report Dysesthesia Scale Questionnaire
timeFrame: Baseline and Year 1
measure: Change in Motility Exam (Hess Screen Test)
timeFrame: Baseline and Year 1
measure: Change in Motility Exam (Worth 4-dot)
timeFrame: Baseline and Year 1
measure: Change in Motility Exam (Stereo Test)
timeFrame: Baseline and Year 1
measure: Change in Motility Exam (9 Gaze Photos)
timeFrame: Baseline and Year 1
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Leon Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: