NCT06295536

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Essilor International · Industry
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ametropia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-28
• Primary completion: 2024-08-23
• Completion: 2024-08-23
• First posted: 2024-03-06
• Last updated: 2025-04-02

Locations

1 site across 1 country: Hong Kong