Algorithm-assisted Subjective Refraction Program Dedicated to Children
NCT ID: NCT07046065
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
166 participants
INTERVENTIONAL
2025-05-23
2025-12-31
Brief Summary
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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.
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Detailed Description
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There are two phases in the investigation:
Phase A:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vA (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Phase B:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vB with additional attention and cooperation stages (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter
Measurement of the non-cycloplegic refraction with Vision-R™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-R™ phoropter and comparison with non-cycloplegic refraction with Vision-R™ phoropter.
Non-cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
Non-cycloplegic conventional subjective refraction
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)
Performed with Vision-R™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Performed with Vision-R™
Cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
Non-cycloplegic Retinoscopy
Performed with a retinoscope without cycloplegia
Cycloplegic retinoscopy
Performed with a retinoscope with cycloplegia
Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter
Measurement of the non-cycloplegic refraction with Vision-S™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-S™ phoropter and comparison with non-cycloplegic refraction with Vision-S™ phoropter.
Non-cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
Non-cycloplegic conventional subjective refraction
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Performed with Vision-S™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)
Performed with Vision-S™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Performed with Vision-S™
Cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
Non-cycloplegic Retinoscopy
Performed with a retinoscope without cycloplegia
Cycloplegic retinoscopy
Performed with a retinoscope with cycloplegia
Interventions
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Non-cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
Non-cycloplegic conventional subjective refraction
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Performed with Vision-S™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)
Performed with Vision-S™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
Performed with Vision-R™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
Performed with Vision-S™
Cycloplegic Objective refraction
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
Non-cycloplegic Retinoscopy
Performed with a retinoscope without cycloplegia
Cycloplegic retinoscopy
Performed with a retinoscope with cycloplegia
Eligibility Criteria
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Inclusion Criteria
2. Subject able to recognize and name the letters of the Latin alphabet
3. Pupillary distance (PD) not less than 49mm
4. 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
5. Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
6. Visual acuity difference \< 0.20 logMAR between right and left eyes at distance
Exclusion Criteria
2. Amblyopia
3. Strabismus
4. Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
5. Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
6. Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
7. Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
8. Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
9. Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
10. History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
11. Contraindications of cycloplegia (e.g. high Intra-ocular pressure - more than 22mmHg in either eye, narrow anterior angle, history of allergy to cycloplegic agents or seizures, etc)
12. Aphakic or pseudoaphakic (intraocular lens),
13. Prismatic prescription in either Right or Left eye (horizontal or vertical). -
6 Years
12 Years
ALL
Yes
Sponsors
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Essilor International
INDUSTRY
Responsible Party
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Principal Investigators
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José Manuel González- Meijome, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal)
Locations
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Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova de Famalicão, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIV-25-03-051757
Identifier Type: OTHER
Identifier Source: secondary_id
WS10374
Identifier Type: -
Identifier Source: org_study_id
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