Recruiting

Prophylactic Aqueous Suppression

Sponsor:

Credit Valley EyeCare

Code:

NCT01535768

Conditions

Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aqueous Suppressant Eye Drops

Study Details

Brief summary:

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.

Conditions

Glaucoma

Study ID

NCT01535768

Start date

Feb, 2012

Status verified date

Jul, 2017

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

Patients randomized to the intervention group will receive aqueous suppressant eyedrops in a stepwise fashion in order to maintain their intraocular pressure between 7-10mmHg.

no intervention: Control Group

Patients randomized to the control group will receive standard of care treatment. They will not be aqueous suppressed within the first three postoperative months unless the bleb hyperencapsulates.

(If they experience the hyperencapsulation phase, they will continue to receive standard of care treatment, which would then be aqueous suppressant eye drops added in a stepwise fashion)

Interventions

Aqueous Suppressant Eye Drops

Aqueous suppressant eye drops added stepwise to achieve IOP between 7-10mmHg. First, a beta blocker eye drop (timolol 0.25% 1 gtts in study eye BID OR timolol 0.5% 1 gtts in study eye BID).

Next, a topical carbonic anhydrase inhibitor eye drop. (brinzolamide 1% 1 gtts in study eye TID OR dorzolamide 2% 1 gtts in study eye TID) Next, a topical alpha agonist eye drop. (brimonidine 0.1% 1 gtts in study eye TID OR brimonidine 0.15% 1 gtts in study eye TID).

Next, a topical prostaglandin analogue eye drop. (latanoprost 0.005% 1 gtts in study eye qhs OR travoprost 0.004% 1 gtts in study eye qhs OR bimatoprost 0.01% 1 gtts in study eye qhs OR bimatoprost 0.03% 1 gtts in study eye qhs) Finally, stop the topical carbonic anhydrase inhibitor eye drop and start oral acetazolamide. (acetazolamide 250mg PO OD)

Primary outcome measure

  • Intraocular pressure [ Time Frame: 4 months postoperative ]

Central Contacts and Locations

Central contacts

Amandeep S Rai, MD

647-987-4724amandeeprai85@gmail.com

Locations

Credit Valley Eye Care

Recruiting

Mississauga, Ontario, Canada, L5L1W8

Contacts

Amandeep S Rai, MD

647-987-4724amandeeprai85@gmail.com

Principal Investigator:

Devesh K Varma, MD FRCSC

More Information

Sponsor

Credit Valley EyeCare

Last update posted

Jul 21, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Credit Valley EyeCare on 2017-07-21.