Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

NCT00869141 | Completed Phase 4 Results

• 1 other identifier: UCLA IRB#08-10-110-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the occurrence rate of the high pressure phase and the final pressure outcomes between patients treated with glaucoma medication prior to the expected onset of the high pressure phase to those patients who have glaucoma medication started at the onset of the high pressure phase. The investigators hypothesize that if glaucoma medications are started prior to the expected onset of high pressure phase, the high pressure phase will not occur as frequently and the ultimate pressure level will be lower than if the glaucoma medications are started at the onset of this phase.

Conditions

Glaucoma

Keywords

Glaucoma tube shunt procedure

Outcome Measures

Primary Outcomes (3)

• Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma

  Intraocular pressure more than 21 mmHg during the first 6 months after Ahmed valve implantation after the pressure has been reduced to less than 22 mmHg in the first postoperative week

  within 6 months after surgery

• Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma

  intraocular pressure comparison between groups after the Ahmed valve implantation

  3 weeks after surgery

• Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase

  intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

  1 year after surgery

Study Arms (2)

Research arm (postop IOP>10)

EXPERIMENTAL

Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation

Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)

Standard of care arm (postop IOP>17)

ACTIVE COMPARATOR

Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation

Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)

Interventions

glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) DRUG

Subjects may receive glaucoma medications after Ahmed valve implantation

Also known as: Timolol, Brimonidine, Dorzolamide, Brinzolamide

Research arm (postop IOP>10); Standard of care arm (postop IOP>17)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years.

You may not qualify if:

• Unwilling or unable to give consent or unwilling to accept randomization.
• Patient out of area and potentially unavailable for follow-up visits.
• Known allergic reaction to timolol, brimonidine, dorzolamide, brinzolamide, or sulfa drugs.
• Known medical contraindications to the use of beta-blockers, including congestive heart failure, heart block, asthma, and chronic obstructive pulmonary disease.
• Concurrent intraocular procedure with Ahmed glaucoma valve implantation
• Previous Ahmed glaucoma valve implantation

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Juels Stein Eye Institute

Los Angeles, California, 90095, United States

Location

Related Links

• Jules Stein Eye Institute

MeSH Terms

Conditions

Glaucoma

Interventions

Timolol; Brimonidine Tartrate; dorzolamide; brinzolamide

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

Results Point of Contact

• Title: Dr. Simon K. Law
• Organization: Stein Eye Institute

law@jsei.ucla.edu

(310)794-1477

Study Officials

• Simon K Law, MD

  Jules Stein Eye Institute, University of California Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor of Health Sciences

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: December 30, 2015
• Results First Posted: June 17, 2015

Record last verified: 2015-07

Locations

US (1)