Dry Eye SyndromesNCT02031172
Effects of Sustained Reading on the Ocular Surface
An observational study of Dry Eye Syndromes and Sjogren's Syndrome, run by University of Rochester at 1 site in United States.
Trial summary
This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function. People with or without dry eye syndrome may enroll. Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes, Sjogren's Syndrome
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2016
- 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 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to recruit 50 subjects from 3 populations (dry eye, Sjogren's, and healthy controls). Subjects will be recruited regardless of gender, race, or ethnicity; and enrollment will based on specific criteria as described below.
Who may be able to join
None listed.
Who cannot join
- A binocular vision below 20/25 (with habitual correction)
- Any ocular surgery within the last 3 months.
- Mental issues, illiteracy, or language problems which might possibly interfere with reading ability
- History of taking or current use of topical prescription anti-inflammatory eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops). Subjects who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash out period" as per the discretion of the investigator and subject safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, subjects on these medications will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function.
People with or without dry eye syndrome may enroll.
- Conditions
- Dry Eye Syndromes, Sjogren's Syndrome
- Keywords
- Dry Eye Disease, Sjogren's Syndrome, Tear Film, Ocular Surface, Aqueous Tear Deficiency
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
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 |
|---|---|---|
| Subjects with Dry Eye Disease | Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. | |
| Subjects with Sjogren's Syndrome | Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. | |
| Healthy Controls | Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
Measured: 30 minutes
To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: PI is moving to a different institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Hindman, University of Rochester
- Investigators
- Holly B Hindman, MD, Principal investigator, University of Rochester, Flaum Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031172
- Sponsor's protocol ID
- 00048640
- Status last verified
- Aug 2016
- First submitted
- 2 Dec 2013
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sustained Reading on the Ocular Surface
- ClinicalTrials.gov ID
- NCT02031172
- Acronym / sponsor ID
- 00048640
- Conditions
- Dry Eye Syndromes, Sjogren's Syndrome
- Keywords
- Dry Eye Disease, Sjogren's Syndrome, Tear Film, Ocular Surface, Aqueous Tear Deficiency
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI is moving to a different institution.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Jan 2014 (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.
This research is being done to to see if changes in visual reading function correlate with changes in optical and retinal image quality. We hypothesize that changes and deterioration in tear film quality and dynamics may have a negative effect on reading function.
People with or without dry eye syndrome may enroll.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with Dry Eye Disease | – | –Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. |
| Subjects with Sjogren's Syndrome | – | –Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. |
| Healthy Controls | – | –Measures tear film stability, and visual function will be taken before and after a sustained silent reading task. The reading task will take place over 30 minutes, and a comprehension assessment will be given after reading. After completion of the reading task, measures of corneal sensation and structural imaging will be performed. The results from each of 3 cohorts will be compared to ascertain the differences between those populations with and without dry eye. |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit 50 subjects from 3 populations (dry eye, Sjogren's, and healthy controls). Subjects will be recruited regardless of gender, race, or ethnicity; and enrollment will based on specific criteria as described below.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- A binocular vision below 20/25 (with habitual correction)
- Any ocular surgery within the last 3 months.
- Mental issues, illiteracy, or language problems which might possibly interfere with reading ability
- History of taking or current use of topical prescription anti-inflammatory eyedrops (including, cyclosporine and steroids as well as any glaucoma eyedrops). Subjects who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash out period" as per the discretion of the investigator and subject safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, subjects on these medications 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
To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
Time frame: 30 minutes
To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function
Time frame: 30 minutes
Results and safety
The study was stopped early (reason given: PI is moving to a different institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
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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.
Holly B Hindman, MD principal investigator
University of Rochester, Flaum Eye Institute
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 Dry Eye Syndromes and Sjogren's Syndrome, run by University of Rochester 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 0 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Aug 2016. 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 stopped early (reason given: PI is moving to a different institution.). 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?
To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics (time frame: 30 minutes). The study lists 2 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 22 Aug 2016.