GlaucomaPhase 4NCT00869141
Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
A Phase 4 study testing glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) in people with Glaucoma, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Juels Stein Eye Institute
Los Angeles, California, 90095
About this study
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.
- Conditions
- Glaucoma
- Being tested
- glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)
- Keywords
- Glaucoma tube shunt procedure
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)Drug
Also called Timolol, Brimonidine, Dorzolamide, Brinzolamide
Subjects may receive glaucoma medications after Ahmed valve implantation
| Study group | Role | What they receive |
|---|---|---|
| Research arm (postop IOP>10) | Experimental | Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation Receives: Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) |
| Standard of care arm (postop IOP>17) | Active comparator | Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation Receives: Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 6 months after surgery
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
intraocular pressure comparison between groups after the Ahmed valve implantation
Measured: 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
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Law, University of California, Los Angeles
- Investigators
- Simon K Law, MD, Principal investigator, Jules Stein Eye Institute, University of California Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869141
- Sponsor's protocol ID
- UCLA IRB#08-10-110-01
- Status last verified
- Jul 2015
- First submitted
- 24 Mar 2009
- Last updated
- 30 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Earlier Intraocular Pressure Control After Ahmed Glaucoma Valve Implantation for Glaucoma
- ClinicalTrials.gov ID
- NCT00869141
- Acronym / sponsor ID
- UCLA IRB#08-10-110-01
- Conditions
- Glaucoma
- Keywords
- Glaucoma tube shunt procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 25 Mar 2009 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Research arm (postop IOP>10) | Experimental | Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation |
| Standard of care arm (postop IOP>17) | Active comparator | Drug: glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring Ahmed glaucoma valve implantation to control intraocular pressure between the ages of 18 and 85 years.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide)Also: Timolol, Brimonidine, Dorzolamide, BrinzolamideSubjects may receive glaucoma medications after Ahmed valve implantation | Drug | Research arm (postop IOP>10), Standard of care arm (postop IOP>17) |
Primary outcome
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma
Time frame: 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
Intraocular Pressure Control After Ahmed Valve Implantation for Glaucoma
Time frame: 3 weeks after surgery
intraocular pressure comparison between groups after the Ahmed valve implantation
Intraocular Pressure of Eyes With Hypertensive Phase Versus Without Hypertensive Phase
Time frame: 1 year after surgery
intraocular pressure of eyes with hypertensive phase versus without hypertensive phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Jules Stein Eye InstituteLink provided by the sponsor.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon K Law, MD principal investigator
Jules Stein Eye Institute, University of California Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide) in people with Glaucoma, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Hypertensive Phase After Ahmed Valve Implantation for Glaucoma (time frame: within 6 months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.