Spectacle Prescribing in Early Childhood (NCT04728451) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Spectacle Prescribing in Early Childhood
United States88 participantsStarted 2021-03-25
Plain-language summary
The purpose of this study is to compare developmental outcome for young children (12 to 35 months of age) with astigmatism meeting American Academy of Ophthalmology spectacle prescribing guidelines and who are prescribed and provided spectacles for either Full-Time wear (encouraged and reinforced) or Ad Lib wear (wear dependent on child acceptance).
Who can participate
Age range
12 Months – 35 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:
* Parent/guardian provision of signed and dated informed consent form for Baseline/Eligibility Examination.
* Completion of Baseline/Eligibility Examination with cycloplegia.
* Bilateral astigmatism: Astigmatism ≥2.25D in the most astigmatic eye and ≥1.75D in the fellow eye based on manual cycloplegic retinoscopy conducted at Baseline/Eligibility Examination.
* Parent/guardian willing to accept assignment to either randomized group.
* Parent/guardian provision of signed and dated informed consent form for randomized SPEC Study.
* Parent willing to commit to study visits every 180 days, to be contacted (phone, email, or text) for reports of spectacle wear, and to allow their child to wear the TheraMon® sensor on the spectacle headband.
* Child and Family are primarily English or Spanish speaking.
* Parent/guardian does not anticipate moving out of Tucson area prior to their child reaching age 1275 days (approximately age 3 ½ years).
* Parent/guardian has not enrolled another child in the SPEC trial.
Exclusion Criteria:
* Gestational age \<32 weeks (per parent report).
* Anisometropia ≥1.50 D spherical equivalent per manual cycloplegic retinoscopy conducted at the Baseline/Eligibility Examination.
* Current manifest strabismus per Baseline/Eligibility Examination.
* Ocular pathology per Baseline/Eligibility Examination (H44\* or H25\* diagnosis code).
* Previously diagnosed manifest strabismus or other ocular abnormalities (per parent report and per medic…
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
Cognitive Development
Timeframe: Measured at the Developmental and Visual Assessment Visit (when the child is age 1155-1275 days)