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

Last updated: March 28, 2025
Sponsor: Essilor International
Overall Status: Completed

Phase

N/A

Condition

Eye Disorders/infections

Treatment

Comparator device, Closed-field autorefractometer

Clinical Study ID

NCT06295536
WS10363
  • Ages 6-13
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Voluntary, willing to follow the protocol, able to read and understand theinformation form and give free and informed consent (for parents/guardian ofchildren 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

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 withstudy assessment

  • Less than 6 years old, or 13 years old or above at time of informed consent andassent

  • Amblyopia, Cataract, Strabismus.

  • Aphakic or pseudophakic (intraocular implant)

  • Reported severe eye disease involving loss of visual field as in glaucoma, involvingloss of acuity and severe discomfort in low or overly bright environments as inretinitis pigmentosa or reported and treated dry eye.

  • Self-reported neurological deficits, including a history of epileptic pathology orsensory-motor coordination disorders, vestibular or cerebellar pathology (e.g.,balance disorders, nystagmus)

  • Any previous ocular surgery, which might have an influence on vision or interferewith 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

Total Participants: 121
Treatment Group(s): 1
Primary Treatment: Comparator device, Closed-field autorefractometer
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
August 23, 2024

Study 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.

Connect with a study center

  • Hong Kong Polytechnic University

    Hong Kong,
    Hong Kong

    Site Not Available

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