Clinical trial NCT06524115: Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India
Official title: Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Essilor International
Sponsor class: INDUSTRY
First posted: 2024-07-29
Enrollment: 122
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective is to compare the refractive parameters of the photorefraction prototype device without cycloplegia with the refractive parameters of reference device, an autorefractometer with and without cycloplegia.

Detailed description: A single visit will be necessary. After informed consent, and checking of the inclusion and exclusion criteria, investigators will perform measurements with an autorefractometer and with the photorefraction prototype device without cycloplegia followed by an objective refraction with an autorefractometer under cyclopegia.

Eligibility criteria: Inclusion Criteria:

* Voluntary, willing to follow the protocol, able to read and understand the information form and give free and informed consent (for parents/guardian of children subjects) and assent (for subjects aged 6-12 years old
* At least 6 years old and up to 12 years old at time of informed consent and assent
* Average of the equivalent sphere(Sph+Cyl/2) of both eye included in the interval \[-10.00, +8.00\]
* Cylindrical refractive error between 0 and 4.00 D on both eyes
* Corrected binocular visual acuity in distance vision at least 6/9

Exclusion Criteria:

* Incapable of expressing consent
* All categories of persons particularly protected by law
* Subject in another study which might have an influence on vision or interfere with study assessment
* Less than 6 years old, or 13 years old or above at time of informed consent and assent
* Amblyopia, Cataract, Strabismus.
* Aphakic or pseudophakic (intraocular implant)
* Reported severe eye disease involving loss of visual field as in glaucoma, involving loss of acuity and severe discomfort in low or overly bright environments as in retinitis pigmentosa or reported and treated dry eye.
* Self-reported neurological deficits, including a history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (e.g., balance disorders, nystagmus)
* Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...),
* Any myopia control solutions that could affect refractive status of the eye (e.g. Atropine eye drops, Orthokeratology)

Primary outcomes:
measure: Objective refractive error
timeFrame: One day (all measurements are taken during the single visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Sankara Nethralaya, Unit of Medical Research Foundation
state: Tamil Nadu
Study officials:
affiliation: Sankara Nethralaya, Unit of Medical Research Foundation
name: Krishna Kumar
role: PRINCIPAL_INVESTIGATOR
References: