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

NCT06524115 | Completed

• 1 other identifier: WS10364
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (1)

• Objective refractive error

  The refractive error is collected in sphere power (D), cylinder power (D) and cylinder axis (°) and converted in equivalent sphere, J0, J45 (power vector in D)

  One day (all measurements are taken during the single visit)

Study Arms (1)

Photorefraction prototype device

EXPERIMENTAL

\- Photoretinoscopic images without cycloplegia

Device: Comparator device, Closed-field autorefractometer without cycloplegia; Other: Distance visual acuity check using objective refraction without cycloplegia; Device: Comparator device, Closed-field autorefractometer with cycloplegia; Other: Distance visual acuity check using objective refraction with cycloplegia

Interventions

Comparator device, Closed-field autorefractometer without cycloplegia DEVICE

Objective refraction without cycloplegia

Photorefraction prototype device

Distance visual acuity check using objective refraction without cycloplegia OTHER

Distance visual acuity is checked, using objective refraction without cycloplegia

Photorefraction prototype device

Comparator device, Closed-field autorefractometer with cycloplegia DEVICE

Objective refraction with cycloplegia

Photorefraction prototype device

Distance visual acuity check using objective refraction with cycloplegia OTHER

Distance visual acuity is checked, using objective refraction with cycloplegia

Photorefraction prototype device

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Essilor International: lead

Study Sites (1)

Sankara Nethralaya, Unit of Medical Research Foundation

Chennai, Tamil Nadu, 600 006, India

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Krishna Kumar

  Sankara Nethralaya, Unit of Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: October 3, 2024
• Primary Completion: December 10, 2024
• Study Completion: December 10, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)