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

NCT06524115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Ametropia

Interventions

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

Sponsors & Collaborators

  • Essilor International

    lead INDUSTRY

Principal Investigators

  • Krishna Kumar · Sankara Nethralaya, Unit of Medical Research Foundation

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2024-12-10
Completion
2024-12-10

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524115 on ClinicalTrials.gov