The Baerveldt Versus ClearPath Comparison Study

Glaucoma Clinical Trial

Official title:

The Baerveldt Versus ClearPath Comparison Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04468633
• Other study ID #: PRO00105781
• Status: Completed
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: June 29, 2023

Study information

• Verified date: August 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 29, 2023
• Est. primary completion date: June 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Baerveldt 350 implant
The Baerveldt implant is an FDA-approved silicone, non-valved implant.
• Ahmed ClearPath 350 implant
The Ahmed ClearPath is a non-valved glaucoma drainage device.

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intraocular pressure (IOP)		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Primary	Complication rate		Baseline
Primary	Complication rate		Day 1
Primary	Complication rate		Week 1
Primary	Complication rate		Week 4
Primary	Complication rate		Week 6
Primary	Complication rate		Month 3
Primary	Complication rate		Month 6
Primary	Complication rate		Year 1
Secondary	Change in Best corrected visual acuity (BCVA)		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Secondary	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
Secondary	Change in Slit lamp exam (SLE) findings		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Secondary	Change in Dilated fundus exam (DFE)		Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Secondary	Change in Humphrey visual field (HVF)		Baseline and Year 1
Secondary	Change in Ocular coherence tomography (OCT)		Baseline and Year 1
Secondary	Change in Pachymetry		Baseline and Year 1
Secondary	Change in Motility exam (9 gaze photos)		Baseline and Year 1
Secondary	Change in Motility exam (stereo test)	If patient is binocular	Baseline and Year 1
Secondary	Change in Motility exam (Worth 4-dot)	If patient is binocular	Baseline and Year 1
Secondary	Change in Motility exam (Hess Screen Test)	If patient is binocular	Baseline and Year 1
Secondary	Change in Self-report Dysesthesia Scale questionnaire		Baseline and Year 1
Secondary	Quality of life, as measured by glaucoma utility index		Year 1
Secondary	Quality of life, as measured by glaucoma symptom scale		Year 1
Secondary	Quality of life, as measured by glaucoma related quality of life 15 questionnaire		Year 1