Algorithm-assisted Subjective Refraction Program Dedicated to Children

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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). -

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Скрининг

Центры проведения

Португалия · 1 центр

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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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