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OpenTrials
Completed

NCT Number: NCT06524115

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.

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sankara Nethralaya, Unit of Medical Research Foundation

Chennai, Tamil Nadu, 600 006, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Comparator device, Closed-field autorefractometer without cycloplegia

Device

Objective refraction without cycloplegia

Distance visual acuity check using objective refraction without cycloplegia

Other

Distance visual acuity is checked, using objective refraction without cycloplegia

Comparator device, Closed-field autorefractometer with cycloplegia

Device

Objective refraction with cycloplegia

Distance visual acuity check using objective refraction with cycloplegia

Other

Distance visual acuity is checked, using objective refraction with cycloplegia

Primary outcomes

  1. Objective refractive error

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Essilor International

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 29, 2024
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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