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Recruiting NCT07046065

Algorithm-assisted Subjective Refraction Program Dedicated to Children

No phase Interventional Refractive Assessment Refractive Disorders Hyperopia and Myopia Astigmatism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-cycloplegic Objective refraction, Non-cycloplegic conventional subjective refraction, Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™), Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™).
Who it may be relevant to
Registry conditions: Refractive Assessment, Refractive Disorders, Hyperopia and Myopia, Astigmatism. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Portugal
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

The goal of the investigation is to evaluate the accuracy of the Kids refraction software results performed with the phoropters Vision-R™700 and Vision-S™700 compared to the conventional subjective refraction method results performed with Vision-R™700. Phase A of the investigation will focus on the validation of the first version (Kids refraction software vA), and phase B will involve the second version (Kids refraction software vB).

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.

Interventions

  • Device Non-cycloplegic Objective refraction
    Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
  • Device Non-cycloplegic conventional subjective refraction
    Performed with Vision-R™
  • Device Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
    Performed with Vision-R™
  • Device Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
    Performed with Vision-S™
  • Device Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)
    Performed with Vision-R™
  • Device Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)
    Performed with Vision-S™
  • Device Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
    Performed with Vision-R™
  • Device Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)
    Performed with Vision-S™
  • Device Cycloplegic Objective refraction
    Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
  • Device Non-cycloplegic Retinoscopy
    Performed with a retinoscope without cycloplegia

Primary outcome measures

  • Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™) [Time frame: Day 1]
  • Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™) [Time frame: Day 1]
  • Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™) [Time frame: Day 1]
  • Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™) [Time frame: Six months after Day 1]
  • Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™) [Time frame: Six months after Day 1]
  • Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™) [Time frame: Six months after Day 1]
  • Subjective Sphere (with conventional method with Vision-R™) [Time frame: Day 1]
  • Subjective Cylinder (with conventional method, with Vision-R™) [Time frame: Day 1]
  • Subjective Axis (with conventional method, with Vision-R™) [Time frame: Day 1]
  • Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™) [Time frame: From enrollment (Day 1) to the end of the study at 7,5 months]

Eligibility criteria

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

  • Vulnerability of the subject
  • Amblyopia
  • Strabismus
  • 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
  • Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
  • History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
  • 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)
  • Aphakic or pseudoaphakic (intraocular lens),
  • Prismatic prescription in either Right or Left eye (horizontal or vertical). -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

Portugal · 1 center
  • Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão — Vila Nova de Famalicão

Identifiers

NCT: NCT07046065 · WS10374 · CIV-25-03-051757

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗