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

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06295536
• Other study ID #: WS10363
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Essilor International
• Contact: Julien Andoche
• Phone: +330633602300
• Email: andochej[@]essilor.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 115
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• Comparator device, Closed-field autorefractometer
Objective refraction without cycloplegia Distance visual acuity with objective refraction without cycloplegia Objective refraction with cycloplegia Distance visual acuity with objective refraction with cycloplegia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Essilor International

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective refractive error	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)	One day (all measurements are taken during the single visit)