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CompletedNCT00869141Updated Dec 30, 2015Results posted

Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

A Phase 4 interventional study of glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) in Glaucoma, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-30.

Sponsored by University of California, Los Angeles · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Glaucoma

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Keywords

  • Glaucoma tube shunt procedure
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 52 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.

Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Research arm (postop IOP>10)

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

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

  • Active comparator
    Standard of care arm (postop IOP>17)

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

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

Interventions

  • Drugglaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)

    Subjects may receive glaucoma medications after Ahmed valve implantation

    Also known as: Timolol, Brimonidine, Dorzolamide, Brinzolamide

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What researchers measure

Primary outcomes

  1. 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

    Time frame: within 6 months after surgery

  2. Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma

    intraocular pressure comparison between groups after the Ahmed valve implantation

    Time frame: 3 weeks after surgery

  3. Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase

    intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

    Time frame: 1 year after surgery

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Results

Posted Jun 17, 2015

Participant flow

Participant flow — Overall Study
MilestoneResearch ArmStandard of Care Arm
Started2626
Completed2626
Not completed00

Outcome measures

PrimaryRate 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

Time frame:
within 6 months after surgery
Reported as:
Number · participants
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma
participantsResearch ArmStandard of Care Arm
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma912
PrimaryIntraocular Pressure Control After Ahmed Valve Implantation for Glaucoma

intraocular pressure comparison between groups after the Ahmed valve implantation

Time frame:
3 weeks after surgery
Reported as:
Mean · mmHg at postop 3-week
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
mmHg at postop 3-weekResearch ArmStandard of Care Arm
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma15.6 ± 3.620.6 ± 8.9
PrimaryIntraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase

intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

Time frame:
1 year after surgery
Reported as:
Mean · mmHg in 1 year postop
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
mmHg in 1 year postopHypertensive Phase GroupNon-hypertensive Phase Group
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase15.1 ± 5.211.4 ± 4.3

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Research Arm—0/26 (0%)1/26 (3.8%)
Standard of Care Arm—0/26 (0%)2/26 (7.7%)
Most frequent other events
Most frequent other events
EventResearch ArmStandard of Care Arm
Uveitis and conreal edemaEye disorders0/262/26
StrabismusEye disorders1/260/26

Baseline characteristics

Age, Continuous
Age, Continuous(years)Research ArmStandard of Care ArmTotal
Mean67.5 ± 11.661.6 ± 15.364.3 ± 13.8
Sex: Female, Male
Sex: Female, Male(Participants)Research ArmStandard of Care ArmTotal
Female131124
Male131528
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Research ArmStandard of Care ArmTotal
Hispanic or Latino358
Not Hispanic or Latino232144
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Research ArmStandard of Care ArmTotal
American Indian or Alaska Native000
Asian51015
Native Hawaiian or Other Pacific Islander000
Black or African American303
White181634
More than one race000
Unknown or Not Reported000
08

Study locations

1 site
  • Juels Stein Eye Institute
    Los Angeles, California 90095, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00869141
Lead sponsor
University of California, Los Angeles
Responsible party
Simon Law (Clinical Associate Professor of Health Sciences, University of California, Los Angeles) — Principal investigator
First posted
Mar 25, 2009
Start date
Mar 2009
Primary completion
Mar 2013
Completion
Mar 2013
Results posted
Jun 17, 2015
Last update
Dec 30, 2015

Study contacts

Simon K Law, MD
principal investigator · Jules Stein Eye Institute, University of California Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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