Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analys… (NCT07290829) | Clinical Trial Compass
CompletedNot Applicable
Conformity of Conjunctival Hyperemia Assessment in Soft Contact Lens Wearers Using Image J Analysis and Efron Degree System
Indonesia52 participantsStarted 2019-03-28
Plain-language summary
Soft Contact Lens (SCL) use all over the world is still increasing. Ocular surface inflammatory reaction is the most common risk of using SCL. Currently, the standard used to assess this complication is the Efron Degree System (EDS), but it has high variability due its subjectivity. ImageJ gives more objective result with conjunctival vasodilation and vascular density assessment, so that complication management can be given earlier.
Purpose: Evaluate the suitability of SDE with ImageJ analysis in assessing conjunctival hyperemia in SCL use within 2 weeks.
Who can participate
Age range
18 Years – 45 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:
* subject with mild to moderate myopia (-0.50 to -6.00 D)
* age between 18-45 years old
* subject who refuse refractive correction with glasses or surgery
* patient with astigmatism refractive error no more than -1 Diopter
Exclusion Criteria:
* subject with previous intraocular surgery
* subject who is wearing SCL continuously
* subject with history of dry eyes, uveitis, glaucoma, or corneal and conjunctival disorders
* subject with history of allergic reaction to contact lens material or lens wetting solution used in this study
* subject with ongoing eye drop treatment
* female subject with ongoing pregnancy or on breastfeeding
* subject with too improper lens fitting
* subject who work around exposure of chemical substance, smoke, hazardous gas, or fire sparks
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
Efron degree system for hyperemia degree
Timeframe: on day 0 (before using SCL), day 7, and day 14
2
Image J analysis of hyperemia degree
Timeframe: on day 0 (before using SCL), day 7, and day 14