NCT06524115

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (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 without cycloplegia	Objective refraction without cycloplegia
OTHER	Distance visual acuity check using objective refraction without cycloplegia	Distance visual acuity is checked, using objective refraction without cycloplegia
DEVICE	Comparator device, Closed-field autorefractometer with cycloplegia	Objective refraction with cycloplegia
OTHER	Distance visual acuity check using objective refraction with cycloplegia	Distance visual acuity is checked, using objective refraction with cycloplegia

Timeline

• Start date: 2024-10-03
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2024-07-29
• Last updated: 2025-04-04

Locations

1 site across 1 country: India