Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India

NCT ID: NCT06524115

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-03
• Study Completion Date: 2024-12-10

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.

Conditions

Ametropia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Photorefraction prototype device

\- Photoretinoscopic images without cycloplegia

Group Type: EXPERIMENTAL

Comparator device, Closed-field autorefractometer without cycloplegia

Intervention Type: DEVICE

Objective refraction without cycloplegia

Distance visual acuity check using objective refraction without cycloplegia

Intervention Type: OTHER

Distance visual acuity is checked, using objective refraction without cycloplegia

Comparator device, Closed-field autorefractometer with cycloplegia

Intervention Type: DEVICE

Objective refraction with cycloplegia

Distance visual acuity check using objective refraction with cycloplegia

Intervention Type: OTHER

Distance visual acuity is checked, using objective refraction with cycloplegia

Interventions

Comparator device, Closed-field autorefractometer without cycloplegia

Objective refraction without cycloplegia

Intervention Type: DEVICE

Distance visual acuity check using objective refraction without cycloplegia

Distance visual acuity is checked, using objective refraction without cycloplegia

Intervention Type: OTHER

Comparator device, Closed-field autorefractometer with cycloplegia

Objective refraction with cycloplegia

Intervention Type: DEVICE

Distance visual acuity check using objective refraction with cycloplegia

Distance visual acuity is checked, using objective refraction with cycloplegia

Intervention Type: OTHER

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essilor International

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Krishna Kumar

Role: PRINCIPAL_INVESTIGATOR

Sankara Nethralaya, Unit of Medical Research Foundation

Locations

Sankara Nethralaya, Unit of Medical Research Foundation

Chennai, Tamil Nadu, India

Countries

India

Other Identifiers

WS10364

Identifier Type: -

Identifier Source: org_study_id