Optimization of a Photoretinoscopy Method for Determining... | NCT06524115

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

NCT06524115

Sponsor

Essilor International

Status

Completed

Last Update Posted

Apr 4, 2025Actual

Enrollment

122Actual

Phase

Not Applicable

Conditions

Ametropia

Interventions

Comparator device, Closed-field autorefractometer without cycloplegia
Distance visual acuity check using objective refraction without cycloplegia
Comparator device, Closed-field autorefractometer with cycloplegia
Distance visual acuity check using objective refraction with cycloplegia

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 3, 2024Actual

Primary Completion Date

Dec 10, 2024Actual

Completion Date

Dec 10, 2024Actual

First Submitted Date

Jul 23, 2024

First Submission Date that Met QC Criteria

Jul 23, 2024

First Posted Date

Jul 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2025

Last Update Posted Date

Apr 4, 2025Actual

Description Module

Brief 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Photorefraction prototype device	Experimental	- Photoretinoscopic images without cycloplegia	Device: Comparator device, Closed-field autorefractometer without cycloplegia Other: Distance visual acuity check using objective refraction without cycloplegia Device: Comparator device, Closed-field autorefractometer with cycloplegia Other: Distance visual acuity check using objective refraction with cycloplegia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comparator device, Closed-field autorefractometer without cycloplegia	Device	Objective refraction without cycloplegia	Photorefraction prototype device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided