CompletedNot Applicable

Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

United States249 participantsStarted 2012-02-23

Plain-language summary

The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to \<72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.

Who can participate

Age range

12 Months – 71 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

. Age 12 to \< 72 months
. Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
. Astigmatism \< 1.50D in both eyes
. Spherical equivalent anisometropia ≤ +1.50D
. For children 36 to \<72 months of age:
. No evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to \<48 months,20/40 or better for age 48 to \<60 months, and 20/32 or better for ages 60 to \<72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol

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

Number of Participants With Confirmation of Failure Criteria

Timeframe: 36 months after randomization

Trial details

NCT IDNCT01515475

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-02

Results submitted2019-03-21

View on ClinicalTrials.gov More Hyperopia trials

Plain-language summary

Who can participate

Age range

12 Months – 71 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

. Age 12 to \< 72 months
. Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
. Astigmatism \< 1.50D in both eyes
. Spherical equivalent anisometropia ≤ +1.50D
. For children 36 to \<72 months of age:
. No evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to \<48 months,20/40 or better for age 48 to \<60 months, and 20/32 or better for ages 60 to \<72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol

Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria