Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Comparator device, Closed-field autorefractometer

• Registration Number: NCT06295536
• Lead Sponsor: Essilor International

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.

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-06
• Study Start: 2024-03-28
• Primary Completion: 2024-08-23
• Study Completion: 2024-08-23
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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, +0.75]
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photorefraction prototype device	Comparator device, Closed-field autorefractometer	- Photoretinoscopic images without cycloplegia

Primary Outcome Measures

Name	Time	Method
Objective refractive error	One day (all measurements are taken during the single visit)	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)

Trial Locations

Locations (1)

Hong Kong Polytechnic University; 🇭🇰 Hong Kong, Hong Kong