Effects of Sustained Reading on the Ocular Surface (NCT02031172) | Clinical Trial Compass
TerminatedNot Applicable
Effects of Sustained Reading on the Ocular Surface
Stopped: PI is moving to a different institution.
United States34 participantsStarted 2014-03
Plain-language 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.
Who can participate
Age range
50 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General inclusion criteria for all subjects will include:
* Ages 50 to 89 years
* Capacity to give informed consent.
* Self-reported literacy (i.e. a "Yes" answer to the question "Have you learned how to read?")
Additional inclusion criteria for the dry eye group will include both of the below:
* A previous diagnosis of dry eye syndrome by an eyecare specialist
* Ocular Surface Disease Index total scoring of 13 or above
Additional inclusion criteria for the Sjögren's syndrome group will include:
\- A previous diagnosis of Sjögren's syndrome by an immunology specialist, per ACR criteria 22
Additional inclusion criteria for normal control subjects will include:
* No previous history of dry eye diagnosis
* Ocular Surface Disease Index total scoring of 12 or under
* Total corneal and conjunctival staining score of 0
Exclusion criteria will include:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To see if changes in visual reading function correlate with changes in optical and retinal image quality, secondary to changes in tear film dynamics
Timeframe: 30 minutes
2
To determine whether corneal sensation and corneal nerve morphology correlate with sustained reading function