The Effect of Early Glasses on the Development of Amblyopia (NCT04740593) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The Effect of Early Glasses on the Development of Amblyopia
Netherlands601 participantsStarted 2021-05-10
Plain-language summary
In a randomized controlled trial, we will establish whether early glasses for high refractive error at age one reduce the development of amblyopia between age one and four. As a secondary outcome early literacy will be compared in groups with and without glasses.
Who can participate
Age range
12 Months – 18 Months
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:
* Registered at one of the participating CHCs;
* 12-18 months of age;
* Voluntary approval for participation by the parents or legal representative/guardian with provided written informed consent;
* Willingness of the parents/guardian(s) to comply with the study procedures
Exclusion Criteria:
* Congenital syndromes;
* Psychomotor retardation;
* Known hereditary defects;
* Known cardiac disease;
* Severe comorbidity;
* Children's whose parents do not agree to cyclopegia with the use of cyclopentolate 1% eye drops for orthoptic examination (retinacopy) by the study orthoptist;
* Refractive error higher than the AAPOS criteria twofold (i.e. hyperopia \>7 dioptres, anisometropia \>3 dioptres and astigmatism of \>3 dioptres at 90º or 180º and \>2 dioptres in oblique axis (\>10º eccentric to 90º or 180º);
* Strabismus;
* Amblyopia;
* Ptosis;
* Cataract or other media opacity;
* Other ophthalmic disease requiring immediate referral;
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
The occurrence of amblyopia at the final examination, stratified according to visual acuity of the amblyopic eye in the intervention group (group 1) and in the control group (group 2)