Three Dimension Tomography of Eye Structures by White Light Imaging Device (NCT02424266) | Clinical Trial Compass
UnknownNot Applicable
Three Dimension Tomography of Eye Structures by White Light Imaging Device
60 participantsStarted 2015-04
Plain-language summary
The purpose of this study is to investigate the ability of an imaging device, developed by AdOM Advanced Optical Technologies Ltd. ("AdOM"). The device allows a three-dimensional imaging of the ocular tissues, specifically the tear film layers and the retinal layers. The device is based on the use of white light.
In this initial study, the device will be used to assess the tear film which coats the corneal surface in healthy subjects as well as in moderate-to-severe Keratoconjunctivitis Sicca (KCS) or Dry Eye Syndrome (DES). The ability of the device to assess the retinal layers will be evaluated in the second phase of the study.
Who can participate
Age range
18 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.
Inclusion criteria
. The presence of at least one ocular symptom of dryness scored at \> 2 (where 0 = none and 4 = very severe /interferes with normal activities)
. Positive Schirmer test (ST without anesthesia) \< 7 mm/5 min in either eye
. Positive fluorescein stainig (FS), defined as a corneal punctate fluorescein staining score of \> 1 in either eye, where 0 = none and 3 = severe.
Exclusion criteria
. Stevens-Johnson Syndrome
. Post-burn ocular injury
. Chronic ocular disease other than KCS requiring topical treatment
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.
1This trial is looking at a white light imaging device to take 3D pictures of eye structures — can you explain how this type of imaging works and whether it might be useful for evaluating my dry eye condition?
2Since this study is enrolling both healthy people and those with moderate to severe dry eye or keratoconjunctivitis sicca, would my specific diagnosis and severity level make me a reasonable candidate to discuss with the research team?
3The trial's main outcome is measuring ocular safety symptoms — what kinds of eye discomfort or reactions should I watch for if I were to participate, and how would those be monitored during the study?
4The recruitment status for this trial is listed as unknown, which could mean it's no longer actively enrolling — can you help me find out whether this study is still open and accepting participants before I get my hopes up?
5If this imaging study doesn't directly offer treatment for my dry eye syndrome, would participating still give us useful diagnostic information about my eyes, or would standard clinical exams already tell us what we need to know?
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.