Open Angle GlaucomaNCT01994564
Prevalence of Dyschromatopsia in Glaucoma Patients
An observational study of Open Angle Glaucoma, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jan 2014
- 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: Patients with a diagnosis of open-angle glaucoma of the Glaucoma Department at Massachusetts Eye \& Ear Infirmary, Boston, MA 02114, US
Who may be able to join
- diagnosis of open angle glaucoma
- visual acuity >/= 20/50
- age >/= 18 (no upper limit)
- male or female gender
Who cannot join
- other type of glaucoma
- age <18
- other retinal disease (e.g. age related macular degeneration)
- other disease affecting the optic nerve or the retinal nerve fibers
- known color blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
About this study
Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. Furthermore, the retinal nerve fiber layers from different receptors for different colors are ordered in a special manner as well. Thus, it is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).
At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or only in end-stage glaucoma.
By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma and in different stages of the disease will be investigated.
- Conditions
- Open Angle Glaucoma
- Keywords
- OAG
- Medical subject headings
- Glaucoma, Open-Angle
What is being measured
The primary outcome is the main question the study is designed to answer.
Result from Ishihara Test
Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.
Measured: Visit 1
Secondary outcomes (1)
Glaucoma stage
Visual field will be tested with 30-2 Humphrey visual field full threshold test. Visual field defects will we graded following the Hodapp-Anderson-Parrish Scale (Hodapp E, Parrish RK, Anderson DR. Classification of Defects in Clinical Decisions in Glaucoma. St. Louis: Mosby, 1993:52-61).
Measured: Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas J. Rhee, M.D., Principal investigator, Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994564
- Sponsor's protocol ID
- 356715-1 Dyschromatopsia
- Status last verified
- Jul 2012
- First submitted
- 19 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Dyschromatopsia in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT01994564
- Acronym / sponsor ID
- 356715-1 Dyschromatopsia
- Conditions
- Open Angle Glaucoma
- Keywords
- OAG
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 26 Nov 2013 (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.
Glaucoma is a progressive disease resulting in loss of retinal nerve cells and their axons (retinal nerve fibers). Retinal nerve fibers are ordered in a special manner when they enter the optic nerve. Hence, damage to the retinal nerve fibers by glaucoma results in visual field defects at certain locations. Furthermore, the retinal nerve fiber layers from different receptors for different colors are ordered in a special manner as well. Thus, it is possible that glaucomatous damage causes color vision dysfunction (dyschromatopsia).
At the moment there is disagreement whether dyschromatopsia occurs at early- to mid-stage or only in end-stage glaucoma.
By testing color vision in glaucoma patients the prevalence of dyschromatopsia in glaucoma and in different stages of the disease will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of open-angle glaucoma of the Glaucoma Department at Massachusetts Eye \& Ear Infirmary, Boston, MA 02114, US
Key inclusion criteria (4 listed)
- diagnosis of open angle glaucoma
- visual acuity >/= 20/50
- age >/= 18 (no upper limit)
- male or female gender
Key exclusion criteria (5 listed)
- other type of glaucoma
- age <18
- other retinal disease (e.g. age related macular degeneration)
- other disease affecting the optic nerve or the retinal nerve fibers
- known color blindness
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
Result from Ishihara Test
Time frame: Visit 1
Color vision will be tested once by Ishihara plates. Both eyes will be tested separately.
1 secondary outcome
Glaucoma stage
Time frame: Visit 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
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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.
Douglas J. Rhee, M.D. principal investigator
Massachusetts Eye & Ear Infirmary, Harvard Medical School, Boston, MA, US
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 Massachusetts Eye and Ear Infirmary 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 4 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: withdrawn, as of the sponsor's last update on 26 Nov 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Result from Ishihara Test (time frame: Visit 1). 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 26 Nov 2013.