Heidelberg In Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Di… (NCT04025801) | Clinical Trial Compass
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Heidelberg In Vivo Confocal Microscopy to Evaluate the Ocular Surface Disorders of Healthy and Diseased Individuals
Taiwan400 participantsStarted 2019-07-31
Plain-language summary
In vivo confocal microscopy (IVCM) has been used in clinical settings for more than 25 years, and is noninvasive, rapid and easily repeatable technique to investigate ocular surface disorders. It enables morphological and quantitative analysis of ocular surface microstructure. \[1-3\] As the technology advances, new IVCM machine, Heidelberg Retinal Tomograph with Rostock Corneal Module (HRT-RCM), was developed. Hardware and software modifications and acquisition techniques continue to expand the applications of the HRT-RCM for quantitative in vivo corneal imaging at the cellular level. The new software can access the corneal nerve more accurate. Here the investigators proposed this Institutional Review Board (IRB) to collect healthy persons and cases of different systematic diseases as well as etiologies of ocular surface diseases.
Who can participate
Age range
20 Years – 40 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
. healthy individuals
. patient with systematic diseases: diabetes, hypertension, Fabry disease, metabolic diseases, Alzheimer's disease and dementia \[15\]…etc.
. patient with ocular surface problems: a. limbal insufficiency b. phlyctenulosis c. ocular rosacea e. ocular graft-versus-host disease (GVHD) f. dry eye syndrome (both aqueous deficiency or increased evaporative forms of dry eyes) h. after corneal transplantation i. other ocular surface diseases (long term use of anti-glaucoma eye drops)
Exclusion criteria
. Age \< 20-year-old.
. Pregnancy.
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
Confocal microscopy exam of sub-basal corneal nerve fibre density (NFD) by using the CCMetrics software
Timeframe: Baseline, 3 months and 6 months.
2
Confocal microscopy exam of sub-basal corneal nerve branch density (NBD) by using the CCMetrics software
Timeframe: Baseline, 3 months and 6 months.
3
Confocal microscopy exam of sub-basal corneal nerve fibre length (NFL) by using the CCMetrics software
Timeframe: Baseline, 3 months and 6 months.
4
Confocal microscopy exam of sub-basal corneal nerve fibre tortuosity (NFT) by using the CCMetrics software