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

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, 600 006
      • Sankara Nethralaya, Unit of Medical Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Photorefraction prototype device; - Photoretinoscopic images without cycloplegia

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Essilor International
• Investigators: Principal Investigator: Krishna Kumar, Sankara Nethralaya, Unit of Medical Research Foundation

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2024
• Primary Completion (Actual): December 10, 2024
• Study Completion (Actual): December 10, 2024

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: WS10364

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No