Open Angle GlaucomaRiGORNCT01645319
Comparative Effectiveness of Treatment Strategies for Primary Open-Angle Glaucoma
An observational study of Open Angle Glaucoma, run by Agency for Healthcare Research and Quality (AHRQ) at 1 site in United States.
Trial summary
The primary objectives of the study are: 1. To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- How many people
- 2,597 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jul 2013
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the United States, the prevalence of open-angle glaucoma for all adults 40 years old and older is estimated to be 1.86%. Open-angle glaucoma affects an estimated 2.22 million people, and that will rise to 3.3 million in 2020 as the population ages in the United States. Worldwide, it is estimated that 66.8 million people have glaucoma. Glaucoma of all types is one of the leading causes of legal blindness in the country.
Who may be able to join
- All adult patients with open-angle glaucoma who have a new or change in therapy (decision to proceed to laser or incisional surgery or initiate a new or additional course of medication).
- Includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation.
- Patients willing to complete visual function and quality of life questionnaires
Who cannot join
- Patients currently treated with four or more glaucoma medications (at time of enrollment).
- Patients with no light perception, or otherwise not eligible for further treatment
- Patients who have neovascular glaucoma, patients with uveitis-associated glaucoma, or patients with angle recession glaucoma.
- Patients with primary angle-closure or secondary angle-closure glaucoma
- Patients who have had prior incisional surgery for glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma
The primary objectives of the study are:
- To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation.
- To compare the proportion of patients who achieve a successful response to treatment (reduction in IOP of >15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation.
The study is a prospective, observational cohort study and will not provide or recommend any treatment. Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up after enrollment targets have been reached.
- Conditions
- Open Angle Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| White, non-hispanic - Medication Treatment Pathway | Not described | |
| White, non-Hispanic - Laser Surgery Treatment Pathway | Not described | |
| White, non-Hispanic - Incisional/Other Treatment Pathway | Not described | |
| Hispanic - Medication Treatment Pathway | Not described | |
| Hispanic - Laser Surgery Treatment Pathway | Not described | |
| Hispanic - Incisional/Other Surgery Treatment Pathway | Not described | |
| Asian - Medication Treatment Pathway | Not described | |
| Asian - Laser Surgery Treatment Pathway | Not described | |
| Asian - Incisional/Other Surgery Treatment Pathway | Not described | |
| Black - Medication Treatment Pathway | Not described | |
| Black - Laser Surgery Treatment Pathway | Not described | |
| Black - Incisional/Other Surgery Treatment Pathway | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcomes of interest are IOP, visual function, and quality of life.
Measured: 12 Months
Secondary outcomes (1)
Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startFeb 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,597 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)
- Sponsor type
- US federal agency
- Collaborators
- American Academy of Ophthalmology, Jules Stein Eye Institute
- Responsible party
- Sponsor
- Investigators
- Rich Gliklich, MD, Principal investigator, Outcome DEcIDE Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645319
- Sponsor's protocol ID
- HHSA29020050035I
- Acronym
- RiGOR
- Status last verified
- Jul 2012
- First submitted
- 20 Oct 2011
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study Comparing the Effectiveness of Treatment Strategies for Open-Angle Glaucoma
- ClinicalTrials.gov ID
- NCT01645319
- Acronym / sponsor ID
- RiGOR / HHSA29020050035I
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,597 participants (actual)
- Lead sponsor
- Agency for Healthcare Research and Quality (AHRQ)US federal agency
- Collaborators
- American Academy of Ophthalmology, Jules Stein Eye Institute
- Study start
- Feb 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 20 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of the study are:
- To compare the proportion of patients who achieve a successful response to treatment (reduction in Intraocular Pressure (IOP) of >15%) between patients treated with laser surgery (including argon laser trabeculectomy, and selective laser trabeculoplasty) with patients receiving additional medications, at 1-year post-treatment initiation.
- To compare the proportion of patients who achieve a successful response to treatment (reduction in IOP of >15%) between patients treated with other procedures (including incisional surgery, drainage device procedures, and other glaucoma procedures) with patients receiving additional medications, at 1-year-post-treatment initiation.
The study is a prospective, observational cohort study and will not provide or recommend any treatment. Patients who have failed initial medical therapy with two glaucoma medications will be identified and enrolled at the time of scheduling of a laser surgery procedure or other procedure such as incisional surgery or drainage device, or initiation of an additional course of therapy with medication as determined by their physician. This inception cohort of new initiators of laser surgical treatment, other procedures, or additional medical therapy will be followed for 12 months. All decisions regarding treatment are solely at the discretion of the physician in accordance with their usual practice. Enrollment is expected to begin in February 2011 and continue through 12 months of follow-up after enrollment targets have been reached.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| White, non-hispanic - Medication Treatment Pathway | – | – |
| White, non-Hispanic - Laser Surgery Treatment Pathway | – | – |
| White, non-Hispanic - Incisional/Other Treatment Pathway | – | – |
| Hispanic - Medication Treatment Pathway | – | – |
| Hispanic - Laser Surgery Treatment Pathway | – | – |
| Hispanic - Incisional/Other Surgery Treatment Pathway | – | – |
| Asian - Medication Treatment Pathway | – | – |
| Asian - Laser Surgery Treatment Pathway | – | – |
| Asian - Incisional/Other Surgery Treatment Pathway | – | – |
| Black - Medication Treatment Pathway | – | – |
| Black - Laser Surgery Treatment Pathway | – | – |
| Black - Incisional/Other Surgery Treatment Pathway | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the United States, the prevalence of open-angle glaucoma for all adults 40 years old and older is estimated to be 1.86%. Open-angle glaucoma affects an estimated 2.22 million people, and that will rise to 3.3 million in 2020 as the population ages in the United States. Worldwide, it is estimated that 66.8 million people have glaucoma. Glaucoma of all types is one of the leading causes of legal blindness in the country.
Key inclusion criteria (3 listed)
- All adult patients with open-angle glaucoma who have a new or change in therapy (decision to proceed to laser or incisional surgery or initiate a new or additional course of medication).
- Includes patients with normal-tension glaucoma, pigmentary glaucoma and pseudoexfoliation.
- Patients willing to complete visual function and quality of life questionnaires
Key exclusion criteria (5 listed)
- Patients currently treated with four or more glaucoma medications (at time of enrollment).
- Patients with no light perception, or otherwise not eligible for further treatment
- Patients who have neovascular glaucoma, patients with uveitis-associated glaucoma, or patients with angle recession glaucoma.
- Patients with primary angle-closure or secondary angle-closure glaucoma
- Patients who have had prior incisional surgery for glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcomes of interest are IOP, visual function, and quality of life.
Time frame: 12 Months
1 secondary outcome
Secondary outcomes of interest include visual field assessment, visual acuity, treatment complications and repeat surgeries.
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2014.
Related trials for Open Angle Glaucoma
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)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
Rich Gliklich, MD principal investigator
Outcome DEcIDE Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, run by Agency for Healthcare Research and Quality (AHRQ) 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 3 inclusion and 5 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 8 Jan 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcomes of interest are IOP, visual function, and quality of life. (time frame: 12 Months). 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 8 Jan 2014.