Glaucoma, Open-AngleNCT01254058
Saccadic Eye Movements Are Impaired In Glaucoma
An observational study of Glaucoma, Open-Angle, run by Unity Health Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether rapid eye movements called saccades are impaired in glaucoma, a neurodegenerative disease of visual pathways. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Glaucoma, Open-Angle
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Apr 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 19 glaucoma patients and 21 age-matched controls will be identified and consented.
Who may be able to join
- Ages from 40-80 years. Primary open angle glaucoma is defined by characteristic glaucomatous optic nerve head findings and the presence of corresponding visual field deficits in one or both eyes. All control subjects will be age-matched, with no ocular medical or surgical history, and a completely normal eye examination. Age-matched controls will be recruited from local hospital personnel and accompanying relatives.
Who cannot join
- Any patient with a history of other eye disease, neurological disease or neurodegenerative disorder, or history of incisional ocular surgery within the previous month will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Vision Testing Paradigms for Patients With Glaucoma
The purpose of this study is to determine whether rapid eye movements called saccades are impaired in glaucoma, a neurodegenerative disease of visual pathways.
Read the detailed description
Eye movements that quickly scan a visual scene are critical to a number of daily activities including driving. It is not known whether rapid eye movement called saccades, are altered in glaucoma.
- Conditions
- Glaucoma, Open-Angle
- 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 |
|---|---|---|
| Glaucoma Group | Not described | |
| Age-Matched Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay in saccades
Measured: April 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neeru Gupta, MD, PhD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254058
- Sponsor's protocol ID
- REB 06-056
- Status last verified
- Sep 2019
- First submitted
- 2 Dec 2010
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Gupta N, Krishnadev N, Hamstra SJ, Yucel YH. Depth perception deficits in glaucoma suspects. Br J Ophthalmol. 2006 Aug;90(8):979-81. doi: 10.1136/bjo.2006.091025. Epub 2006 May 3.
PubMed 16672326Kanjee R, Yucel YH, Steinbach MJ, Gonzalez EG, Gupta N. Delayed saccadic eye movements in glaucoma. Eye Brain. 2012 Nov 26;4:63-68. doi: 10.2147/EB.S38467. eCollection 2012.
PubMed 28539782
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Vision Testing Paradigms for Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT01254058
- Acronym / sponsor ID
- REB 06-056
- Conditions
- Glaucoma, Open-Angle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 6 Dec 2010 (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 purpose of this study is to determine whether rapid eye movements called saccades are impaired in glaucoma, a neurodegenerative disease of visual pathways.
Detailed description
Eye movements that quickly scan a visual scene are critical to a number of daily activities including driving. It is not known whether rapid eye movement called saccades, are altered in glaucoma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glaucoma Group | – | – |
| Age-Matched Controls | – | – |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 19 glaucoma patients and 21 age-matched controls will be identified and consented.
Key inclusion criteria (1 listed)
- Ages from 40-80 years. Primary open angle glaucoma is defined by characteristic glaucomatous optic nerve head findings and the presence of corresponding visual field deficits in one or both eyes. All control subjects will be age-matched, with no ocular medical or surgical history, and a completely normal eye examination. Age-matched controls will be recruited from local hospital personnel and accompanying relatives.
Key exclusion criteria (1 listed)
- Any patient with a history of other eye disease, neurological disease or neurodegenerative disorder, or history of incisional ocular surgery within the previous month will be excluded.
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
Delay in saccades
Time frame: April 2014
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 16672326Gupta N, Krishnadev N, Hamstra SJ, Yucel YH. Depth perception deficits in glaucoma suspects. Br J Ophthalmol. 2006 Aug;90(8):979-81. doi: 10.1136/bjo.2006.091025. Epub 2006 May 3.
- Results publication: PubMed 28539782Kanjee R, Yucel YH, Steinbach MJ, Gonzalez EG, Gupta N. Delayed saccadic eye movements in glaucoma. Eye Brain. 2012 Nov 26;4:63-68. doi: 10.2147/EB.S38467. eCollection 2012.
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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.
Neeru Gupta, MD, PhD principal investigator
Unity Health Toronto
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 Glaucoma, Open-Angle, run by Unity Health Toronto at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Sep 2019. 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 Canada. 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?
Results are not available in the source record.
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?
Delay in saccades (time frame: April 2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01254058, which also lists 2 linked publications.
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 25 Sep 2019.