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Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma tube shunt procedure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Juels Stein Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Research arm (postop IOP>10)

Standard of care arm (postop IOP>17)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
intraocular pressure comparison between groups after the Ahmed valve implantation
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

Secondary Outcome Measures

Full Information

First Posted
March 24, 2009
Last Updated
November 30, 2015
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00869141
Brief Title
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
Official Title
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Tube shunt procedures are a popular surgery for the control of glaucoma. Tube shunt devices are designed to drain eye fluid (aqueous humor) through a tube inserted into the front chamber of the eye (anterior chamber) to a plate secured to the mid-posterior section of the outer eyeball wall. The body then lays down collagen tissue and forms a capsule around the plate. The fluid filters through the capsule of collagen tissue and is reabsorbed into the ocular and systemic circulation. The collagen tissue continues to remodel itself over a long period of time (up to years). However, a well characterized, yet poorly understood, phenomenon occurs in many patients in the 4-8 weeks after the device's implantation, called the hypertensive phase. The pressure of the eye can increase from a desirable level of about 10 immediately after the tube shunt implantation to much higher levels, in the range of 20 to 30's, and then it may gradually return to less than 20. Such a high pressure phase can cause irreversible damage an eye with glaucoma. The usual management of a high pressure phase is to start glaucoma medications as soon as it is detected. A previous study we conducted showed that this high pressure phase resolves in about half of patients with medical therapy, but the other half may continue to have higher than expected pressures. The exact cause of this high pressure phase is unknown. However, it is postulated that the mechanism may involve a compaction collagen tissue layers under the eye's own fluid pressure while the collagen tissue is being laid down, which in turn creates a firm, dense capsule that makes escape of fluid difficult. Therefore, it is argued that if the formation of eye fluid is reduced by medication during this initial period when the collagen tissue is laid down, the compaction of collagen, and subsequently the high pressure phase may be avoided. 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. We 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. We believe that this study will have a very significant impact on the management of glaucoma with tube shut procedures. If it is true that the rate and pressure level of the hypertensive phase can be reduced by simply starting glaucoma medications to reduce the formation of eye fluid before the expected the high pressure phase begins, which is generally 4 weeks after implantation of the tube shunt device, glaucoma patients can be saved from exposure to the very high level of eye pressure, and the eventual pressure control may be better.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma tube shunt procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Research arm (postop IOP>10)
Arm Type
Experimental
Arm Description
Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
Arm Title
Standard of care arm (postop IOP>17)
Arm Type
Active Comparator
Arm Description
Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation
Intervention Type
Drug
Intervention Name(s)
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
Other Intervention Name(s)
Timolol, Brimonidine, Dorzolamide, Brinzolamide
Intervention Description
Subjects may receive glaucoma medications after Ahmed valve implantation
Primary Outcome Measure Information:
Title
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma
Description
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
Time Frame
within 6 months after surgery
Title
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
Description
intraocular pressure comparison between groups after the Ahmed valve implantation
Time Frame
3 weeks after surgery
Title
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
Description
intraocular pressure of eyes with hypertensive phase versus without hypertensive phase
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon K Law, MD
Organizational Affiliation
Jules Stein Eye Institute, University of California Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juels Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.jsei.org/
Description
Jules Stein Eye Institute

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Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

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