Effect of Prophylactic Aqueous Suppression on Hyperencapsulation of Ahmed Glaucoma Valves

NCT01535768 | Unknown Phase 4 DMC

• 1 other identifier: PASAGV2012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  The primary outcome measure is intraocular pressure (IOP) at 4 months postoperative. This will be a washout IOP (i.e. all glaucoma eye drops will be stopped at 3 months postoperative in all study patients)

  4 months postoperative

Secondary Outcomes (4)

• Hyperencapsulation phase (HEP)

  first 3 months postoperative

• Qualified Ahmed Glaucoma Valve success

  12 months

• Absolute Ahmed Glaucoma Valve success

  13 months

• Number of glaucoma medications

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Drug: Aqueous Suppressant Eye Drops

Control Group

NO INTERVENTION

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 DRUG

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)

Also known as: Timoptic, Trusopt, Azopt, Alphagan-P, Xalatan, Travatan Z, Lumigan, Diamox

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of glaucoma
• scheduled for Ahmed glaucoma valve surgery, with or without simultaneous cataract surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Credit Valley EyeCare: lead
• Canadian Glaucoma Clinical Research Council: collaborator

Study Sites (1)

Credit Valley Eye Care

Mississauga, Ontario, L5L1W8, Canada

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; dorzolamide; brinzolamide; Brimonidine Tartrate; Latanoprost; Travoprost; Bimatoprost; Acetazolamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cloprostenol; Amides

Study Officials

• Devesh K Varma, MD FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Ike K Ahmed, MD FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Amandeep S Rai, MD

  University of Toronto

  STUDY DIRECTOR

Central Study Contacts

Amandeep S Rai, MD

CONTACT

647-987-4724; amandeeprai85@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Glaucoma and Advanced Anterior Segment Surgery Research Fellow, Principal Investigator

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 20, 2012
• Study Start: February 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2020
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

CA (1)