Algorithm-assisted Subjective Refraction Program Dedicated to Children (NCT07046065) | Clinical Trial Compass
RecruitingNot Applicable
Algorithm-assisted Subjective Refraction Program Dedicated to Children
Portugal166 participantsStarted 2025-05-23
Plain-language summary
Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software.
Two different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB).
The software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.
Who can participate
Age range
6 Years – 12 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
. Age between 6 and 12 years
. Subject able to recognize and name the letters of the Latin alphabet
. Pupillary distance (PD) not less than 49mm
. Distance refractive error for spherical equivalence (SE) within the range of \[-6.00 to +6.00 D\] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D
. Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
. Visual acuity difference \< 0.20 logMAR between right and left eyes at distance
Exclusion criteria
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
Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Timeframe: Day 1
2
Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Timeframe: Day 1
3
Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Timeframe: Day 1
4
Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Timeframe: Six months after Day 1
5
Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Timeframe: Six months after Day 1
6
Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Timeframe: Six months after Day 1
7
Subjective Sphere (with conventional method with Vision-R™)
. Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
. Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
. Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
. Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
. Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
8
Subjective Cylinder (with conventional method, with Vision-R™)
Timeframe: Day 1
9
Subjective Axis (with conventional method, with Vision-R™)
Timeframe: Day 1
10
Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Timeframe: From enrollment (Day 1) to the end of the study at 7,5 months
11
Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Timeframe: From enrollment (Day 1) to the end of the study at 7,5 months
12
Visual acuity (with Conventionnal refraction method, with Vision-R™)
Timeframe: From enrollment (Day 1) to the end of the study at 7,5 months