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Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00869141
Enrollment
52
Registered
2009-03-25
Start date
2009-03-31
Completion date
2013-03-31
Last updated
2015-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

Glaucoma tube shunt procedure

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.

Interventions

DRUGglaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)

Subjects may receive glaucoma medications after Ahmed valve implantation

Sponsors

University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucomawithin 6 months after surgeryIntraocular 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 Glaucoma3 weeks after surgeryintraocular pressure comparison between groups after the Ahmed valve implantation
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase1 year after surgeryintraocular pressure of eyes with hypertensive phase versus without hypertensive phase

Countries

United States

Participant flow

Participants by arm

ArmCount
Research Arm
Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
26
Standard of Care Arm
Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation
26
Total52

Baseline characteristics

CharacteristicStandard of Care ArmTotalResearch Arm
Age, Continuous61.6 years
STANDARD_DEVIATION 15.3
64.3 years
STANDARD_DEVIATION 13.8
67.5 years
STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants8 Participants3 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants44 Participants23 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
10 Participants15 Participants5 Participants
Race (NIH/OMB)
Black or African American
0 Participants3 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
16 Participants34 Participants18 Participants
Sex: Female, Male
Female
11 Participants24 Participants13 Participants
Sex: Female, Male
Male
15 Participants28 Participants13 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
1 / 262 / 26
serious
Total, serious adverse events
0 / 260 / 26

Outcome results

Primary

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

Population: Eye pressure at postop 3-week is reported

ArmMeasureValue (MEAN)Dispersion
Research ArmIntraocular Pressure Control After Ahmed Valve Implantation for Glaucoma15.6 mmHg at postop 3-weekStandard Deviation 3.6
Standard of Care ArmIntraocular Pressure Control After Ahmed Valve Implantation for Glaucoma20.6 mmHg at postop 3-weekStandard Deviation 8.9
Primary

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

Population: Please note that these two groups were different from those groups in previous comparison. The patients that developed hypertensive phase were compared to those that did not developed hypertensive phase, so the number of patients in these two groups and the mean pressure at 1 year +/-standard deviation results were different.

ArmMeasureValue (MEAN)Dispersion
Research ArmIntraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase15.1 mmHg in 1 year postopStandard Deviation 5.2
Standard of Care ArmIntraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase11.4 mmHg in 1 year postopStandard Deviation 4.3
Primary

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

ArmMeasureValue (NUMBER)
Research ArmRate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma9 participants
Standard of Care ArmRate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma12 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026