Algorithm-assisted Subjective Refraction Program Dedicated to Children

Essilor International166 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 6 and 12 years 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: 1. Vulnerability of the subject 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). -

Outcomes

Primary Outcomes

Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.

Time frame: Day 1

Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.

Time frame: Day 1

Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

Indicates the orientation of the Cylinder, measured in degrees (°)

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™)

Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.

Time frame: Six months after Day 1

Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

Indicates the orientation of the Cylinder, measured in degrees (°)

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™)

Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.

Time frame: Day 1

Subjective Axis (with conventional method, with Vision-R™)

Indicates the orientation of the Cylinder, measured in degrees (°)

Time frame: Day 1

Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)

Corrected visual acuity measure with Kids refraction software vA results

Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)

Corrected visual acuity measure with Kids refraction software vB results

Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

Visual acuity (with Conventionnal refraction method, with Vision-R™)

Corrected visual acuity measure with Conventionnal refraction method results

Time frame: From enrollment (Day 1) to the end of the study at 7,5 months

Algorithm-assisted Subjective Refraction Program Dedicated to Children

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts