Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves

Condition(s) targeted: Glaucoma

Intervention: Aqueous Suppressant Eye Drops (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Credit Valley EyeCare

Official(s) and/or principal investigator(s):
Devesh K Varma, MD FRCSC, Principal Investigator, Affiliation: University of Toronto
Ike K Ahmed, MD FRCSC, Principal Investigator, Affiliation: University of Toronto
Amandeep S Rai, MD, Study Director, Affiliation: University of Toronto

Overall contact:
Amandeep S Rai, MD, Phone: 647-987-4724, Email: amandeeprai85@gmail.com

After implantation of an Ahmed glaucoma valve in patients with glaucoma, hyperencapsulation phase is an unwanted postoperative phenomenon, typically occurring with the free 3 months postoperatively. When this does occur, it is treated with aqueous suppressant eye drops. This study aims to determine if it is possible to reduce the rate of hyperencapsulation phase. Patients in the treatment group will receive aqueous suppressant eye drops before the hyperencapsulation phase starts. Treatment will be initiated once their intraocular pressure is above a pre-defined level, and will target a pre-defined range.

Official title: Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Intraocular pressure

Secondary outcome:

Hyperencapsulation phase (HEP)

Qualified Ahmed Glaucoma Valve success

Absolute Ahmed Glaucoma Valve success

Number of glaucoma medications

Detailed description: Patients with glaucoma requiring tube shunt surgery, with or without simultaneous cataract surgery, will be enrolled in this prospective randomized controlled study at ten sites across Canada and the United States (to be determined). Patients with highly advanced glaucoma at high risk of fixation loss, neovascular glaucoma, chronic uveitis, marked corneal disease, sulfa allergy, renal disease or any contraindication to diamox use will be excluded. Patients scheduled for Ahmed glaucoma valve surgery, with or without cataract surgery, will be randomized using a stratified central block randomization approach to the treatment group or control group. Those scheduled for combined cataract and tube shunt will be randomized separately from those receiving tube shunt alone. Surgeons will be masked to the postoperative treatment or control group at the time of surgery since randomization will occur when the patient is one-week postoperative Those in the treatment group would receive short-term prophylactic aqueous suppression for the first 3 postoperative months to maintain intraocular pressure (IOP) between 7 and 10mmHg. The control group would not receive prophylactic aqueous suppression, but would be treated using a similar protocol as the treatment group in the event that an Hyperencapsulation phase (HEP) endpoint is met. Prophylactic aqueous suppression in the study group would only be given for the 1st 3 months postoperatively. At the 3 month visit, aqueous suppression will be stopped. The primary outcome measure is washout IOP at 4 months postoperative. Washout IOP will be checked one month after discontinuation (earlier if needed i. e., advanced glaucoma patients). Beyond 3 months, aqueous suppressants would be used at the clinician's discretion based on IOP. At the conclusion of the study, the 4-month postoperative washout IOP, the incidence of HEP, the 12-month IOP, the 13-month washout IOP, and medication requirement would be compared between the treatment and control arms.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- clinical diagnosis of glaucoma

- scheduled for Ahmed glaucoma valve surgery, with or without simultaneous cataract

surgery Exclusion Criteria:

- neovascular glaucoma

- uveitic glaucoma

- prior tube shunt surgery

- prior cyclodestruction procedure

- abnormal cornea that would make IOP measurements unreliable

- sulfa allergy

- systemic contraindication to acetazolamide use

- inability to attend follow up visits

- intraocular pressure greater than 21 at postoperative week 1 (represents primary

failure of the valve)

- anterior chamber fill within the first week postoperatively

Amandeep S Rai, MD, Phone: 647-987-4724, Email: amandeeprai85@gmail.com

Credit Valley Eye Care, Mississauga, Ontario L5L1W8, Canada; Recruiting
Amandeep S Rai, MD, Phone: 647-987-4724, Email: amandeeprai85@gmail.com
Devesh K Varma, MD FRCSC, Principal Investigator
Ike K Ahmed, MD FRCSC, Sub-Investigator

Starting date: February 2012
Last updated: July 27, 2015