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
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.
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.
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 →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.
Exclusion Criteria:
Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation
Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
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
Also known as: Timolol, Brimonidine, Dorzolamide, Brinzolamide
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
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
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
| Milestone | Research Arm | Standard of Care Arm |
|---|---|---|
| Started | 26 | 26 |
| Completed | 26 | 26 |
| Not completed | 0 | 0 |
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
| participants | Research Arm | Standard of Care Arm |
|---|---|---|
| Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma | 9 | 12 |
intraocular pressure comparison between groups after the Ahmed valve implantation
| mmHg at postop 3-week | Research Arm | Standard of Care Arm |
|---|---|---|
| Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma | 15.6 ± 3.6 | 20.6 ± 8.9 |
intraocular pressure of eyes with hypertensive phase versus without hypertensive phase
| mmHg in 1 year postop | Hypertensive Phase Group | Non-hypertensive Phase Group |
|---|---|---|
| Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase | 15.1 ± 5.2 | 11.4 ± 4.3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Research Arm | — | 0/26 (0%) | 1/26 (3.8%) |
| Standard of Care Arm | — | 0/26 (0%) | 2/26 (7.7%) |
| Event | Research Arm | Standard of Care Arm |
|---|---|---|
| Uveitis and conreal edemaEye disorders | 0/26 | 2/26 |
| StrabismusEye disorders | 1/26 | 0/26 |
| Age, Continuous(years) | Research Arm | Standard of Care Arm | Total |
|---|---|---|---|
| Mean | 67.5 ± 11.6 | 61.6 ± 15.3 | 64.3 ± 13.8 |
| Sex: Female, Male(Participants) | Research Arm | Standard of Care Arm | Total |
|---|---|---|---|
| Female | 13 | 11 | 24 |
| Male | 13 | 15 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Research Arm | Standard of Care Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 23 | 21 | 44 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Research Arm | Standard of Care Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 10 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 18 | 16 | 34 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Los Angeles