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Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT06295536•Essilor International

View on ClinicalTrials.gov

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

Age

6 - 13 years

Sex

ALL

Healthy Volunteers

Yes

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)

Locations (1)

Hong Kong Polytechnic University

Hong Kong, Hong Kong

Key Dates

Start Date

March 28, 2024

Primary Completion Date

August 23, 2024

Completion Date

August 23, 2024

Last Updated

April 2, 2025

Enrollment

121

ACTUAL participants

Conditions

Ametropia

Interventions

Comparator device, Closed-field autorefractometer

DEVICE

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

NCT07322211

Refractive Ametropia

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RECRUITINGNA

The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.

NCT06882408

AmetropiaMyopia; Refractive Error+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses

The Objective of This Study is to Evaluate the Perfomance of a Photorefraction Device for Screening Ametropia in Children. Eligible Participants Will Undergo Multiple Refractive Error Measurements, Visual Acuity and Strabismus Assessments During a Single Evaluation Visit.

Performance of Refractometers With Self-adjusting Lenses Compared to Cycloplegia in Children (REFRALENS)

Comparative Analysis of the Visual Performance and Patient Satisfaction After Cataract Surgery With Implantation of a Medicontur Monofocal (877PAY) or a Medicontur Extended Depth of Focus (877PEY) IOL

Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues

1-Week Dispensing Evaluation of REVIVE™ Toric Soft Contact Lenses