AmetropiaNCT06524115
Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India
A study testing Comparator device, Closed-field autorefractometer without cycloplegia, Distance visual acuity check using objective refraction without cycloplegia and Comparator device, Closed-field autorefractometer with cycloplegia in people with Ametropia, run by Essilor International at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 6 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- Comparator device, Closed-field autorefractometer without cycloplegia, Distance visual acuity check using objective refraction without cycloplegia and Comparator device, Closed-field autorefractometer with cycloplegia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteIndia
- Study dates
- 3 Oct 2024to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
India1 site
Sankara Nethralaya, Unit of Medical Research Foundation
Chennai, Tamil Nadu, 600 006
About this study
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.
Read the 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
- Being tested
- 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
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator device, Closed-field autorefractometer without cycloplegiaDevice
Objective refraction without cycloplegia
Distance visual acuity check using objective refraction without cycloplegiaOther
Distance visual acuity is checked, using objective refraction without cycloplegia
Comparator device, Closed-field autorefractometer with cycloplegiaDevice
Objective refraction with cycloplegia
Distance visual acuity check using objective refraction with cycloplegiaOther
Distance visual acuity is checked, using objective refraction with cycloplegia
| Study group | Role | What they receive |
|---|---|---|
| Photorefraction prototype device | Experimental | - Photoretinoscopic images without cycloplegia Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: One day (all measurements are taken during the single visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start3 Oct 2024
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krishna Kumar, Principal investigator, Sankara Nethralaya, Unit of Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524115
- Sponsor's protocol ID
- WS10364
- Status last verified
- Apr 2025
- First submitted
- 23 Jul 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children With a Smartphone/add-on Device in India
- ClinicalTrials.gov ID
- NCT06524115
- Acronym / sponsor ID
- WS10364
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photorefraction prototype device | Experimental | 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- Photoretinoscopic images without cycloplegia |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator device, Closed-field autorefractometer without cycloplegiaObjective refraction without cycloplegia | Device | Photorefraction prototype device |
| Distance visual acuity check using objective refraction without cycloplegiaDistance visual acuity is checked, using objective refraction without cycloplegia | Other | Photorefraction prototype device |
| Comparator device, Closed-field autorefractometer with cycloplegiaObjective refraction with cycloplegia | Device | Photorefraction prototype device |
| Distance visual acuity check using objective refraction with cycloplegiaDistance visual acuity is checked, using objective refraction with cycloplegia | Other | Photorefraction prototype device |
Primary outcome
Objective refractive error
Time frame: One day (all measurements are taken during the single visit)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krishna Kumar principal investigator
Sankara Nethralaya, Unit of Medical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparator device, Closed-field autorefractometer without cycloplegia, Distance visual acuity check using objective refraction without cycloplegia and Comparator device, Closed-field autorefractometer with cycloplegia in people with Ametropia, run by Essilor International at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective refractive error (time frame: One day (all measurements are taken during the single visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.