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Search / Trial NCT06524115

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

Launched by ESSILOR INTERNATIONAL · Jul 23, 2024

Trial Information

Current as of July 22, 2025

Completed

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • 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)

About Essilor International

Essilor International is a global leader in the ophthalmic optics industry, dedicated to improving vision and enhancing quality of life through innovative eyewear solutions. With a strong commitment to research and development, Essilor focuses on advancing technologies in lens design, manufacturing, and distribution, ensuring that vision care is accessible to all. The company collaborates with healthcare professionals and partners worldwide to conduct clinical trials that evaluate the efficacy and safety of its products, ultimately driving advancements in eye health and vision correction. Through its comprehensive approach, Essilor aims to address the growing global vision challenges and contribute to a healthier, more visually capable society.

Locations

Chennai, Tamil Nadu, India

Patients applied

0 patients applied

Trial Officials

Krishna Kumar

Principal Investigator

Sankara Nethralaya, Unit of Medical Research Foundation

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported