The Baerveldt Versus ClearPath Comparison Study

Study Overview
=================
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.

Official Title
-----------------
The Baerveldt Versus ClearPath Comparison Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Device: Baerveldt 350 implant
* Device: Ahmed ClearPath 350 implant


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baerveldt 350 implant<br> | Device: Baerveldt 350 implant<br>* The Baerveldt implant is an FDA-approved silicone, non-valved implant.<br>|
| Active Comparator: Ahmed ClearPath 350 implant<br> | Device: Ahmed ClearPath 350 implant<br>* The Ahmed ClearPath is a non-valved glaucoma drainage device.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure (IOP) |  | Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1 | 
| Complication rate |  | Baseline | 
| Complication rate |  | Day 1 | 
| Complication rate |  | Week 1 | 
| Complication rate |  | Week 4 | 
| Complication rate |  | Week 6 | 
| Complication rate |  | Month 3 | 
| Complication rate |  | Month 6 | 
| Complication rate |  | Year 1 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baerveldt 350 implant, Ahmed ClearPath implant