Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT00869141
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
• Study Start Date: Mar 1, 2009
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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); Subjects may receive glaucoma medications after Ahmed valve implantation; Other Names: 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); Subjects may receive glaucoma medications after Ahmed valve implantation; Other Names: Timolol, Brimonidine, Dorzolamide, Brinzolamide

Outcome Measures

Primary Outcome Measures

1. Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma [within 6 months after surgery]

   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

2. Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma [3 weeks after surgery]

   intraocular pressure comparison between groups after the Ahmed valve implantation

3. Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase [1 year after surgery]

   intraocular pressure of eyes with hypertensive phase versus without hypertensive phase

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: 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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juels Stein Eye Institute	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Simon K Law, MD, Jules Stein Eye Institute, University of California Los Angeles

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Jules Stein Eye Institute

Publications

None provided.

• Responsible Party: Simon Law, Clinical Associate Professor of Health Sciences, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT00869141
• Other Study ID Numbers: UCLA IRB#08-10-110-01
• First Posted: Mar 25, 2009
• Last Update Posted: Dec 30, 2015
• Last Verified: Jul 1, 2015

• Keywords provided by Simon Law, Clinical Associate Professor of Health Sciences, University of California, Los Angeles: Glaucoma tube shunt procedure
• Additional relevant MeSH terms: Glaucoma; Timolol; Brimonidine Tartrate; Dorzolamide; Brinzolamide

Study Results

Participant Flow

Arm/Group Title	Research Arm	Standard of Care Arm
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	26	26
COMPLETED	26	26
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Research Arm	Standard of Care Arm	Total
Arm/Group Description	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	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	Total of all reporting groups
Overall Participants	26	26	52
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.5 (11.6)	61.6 (15.3)	64.3 (13.8)
Sex: Female, Male (Count of Participants)
Female	13 50%	11 42.3%	24 46.2%
Male	13 50%	15 57.7%	28 53.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 11.5%	5 19.2%	8 15.4%
Not Hispanic or Latino	23 88.5%	21 80.8%	44 84.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	5 19.2%	10 38.5%	15 28.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 11.5%	0 0%	3 5.8%
White	18 69.2%	16 61.5%	34 65.4%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Arm	Standard of Care Arm
Arm/Group Description	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	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
Measure Participants	26	26
Number [participants]	9 34.6%	12 46.2%

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Eye pressure at postop 3-week is reported

Arm/Group Title	Research Arm	Standard of Care Arm
Arm/Group Description	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	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
Measure Participants	26	26
Mean (Standard Deviation) [mmHg at postop 3-week]	15.6 (3.6)	20.6 (8.9)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Hypertensive Phase Group	Non-hypertensive Phase Group
Arm/Group Description	Eyes that developed hypertensive phase after Ahmed valve implantation	Eyes that did not develop hypertensive phase after Ahmed valve implantation
Measure Participants	21	31
Mean (Standard Deviation) [mmHg in 1 year postop]	15.1 (5.2)	11.4 (4.3)

Adverse Events

Arm/Group Title	Research Arm		Standard of Care Arm
Arm/Group Description	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		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
All Cause Mortality
	Research Arm		Standard of Care Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Research Arm		Standard of Care Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Research Arm		Standard of Care Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/26 (3.8%)		2/26 (7.7%)
Eye disorders
Uveitis and conreal edema	0/26 (0%)	0	2/26 (7.7%)	2
Strabismus	1/26 (3.8%)	1	0/26 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.