Refractive AssessmentNCT07046065
Algorithm-assisted Subjective Refraction Program Dedicated to Children
A study testing Non-cycloplegic Objective refraction, Non-cycloplegic conventional subjective refraction and Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) in people with Refractive Assessment and Refractive Disorders, run by Essilor International at 1 site in Portugal.
Trial summary
Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Assessment, Refractive Disorders, Hyperopia and Myopia
- What is being tested?
- Non-cycloplegic Objective refraction, Non-cycloplegic conventional subjective refraction and Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 sitePortugal
- Study dates
- 23 May 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age between 6 and 12 years
- Subject able to recognize and name the letters of the Latin alphabet
- Pupillary distance (PD) not less than 49mm
- Distance refractive error for spherical equivalence (SE) within the range of [-6.00 to +6.00 D] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D
- Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
- Visual acuity difference < 0.20 logMAR between right and left eyes at distance
Who cannot join
- Vulnerability of the subject
- Amblyopia
- Strabismus
- Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
- Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
- Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)
Show all 13Show fewer
- Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP
- Any untreated and/or uncontrolled systemic condition which might have an influence on vision or interfere with study assessments
- Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state
- History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles
- Contraindications of cycloplegia (e.g. high Intra-ocular pressure - more than 22mmHg in either eye, narrow anterior angle, history of allergy to cycloplegic agents or seizures, etc)
- Aphakic or pseudoaphakic (intraocular lens),
- Prismatic prescription in either Right or Left eye (horizontal or vertical). -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site, 1 recruiting
- Recruiting
Centro de Investigação, Inovação e Ensino Superior (CIIES) de Famalicão
Vila Nova de Famalicão, 4764-502
José Manuel González- Meijome, PhD, jgmeijome@fisica.uminho.pt
Botelho Fernandes, pfernandes@fisica.uminho.pt
About this study
Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software.
Two different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB).
The software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.
Read the detailed description
The goal of the investigation is to evaluate the accuracy of the Kids refraction software results performed with the phoropters Vision-R™700 and Vision-S™700 compared to the conventional subjective refraction method results performed with Vision-R™700. Phase A of the investigation will focus on the validation of the first version (Kids refraction software vA), and phase B will involve the second version (Kids refraction software vB).
There are two phases in the investigation:
Phase A:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vA (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Phase B:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vB with additional attention and cooperation stages (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
- Conditions
- Refractive Assessment, Refractive Disorders, Hyperopia and Myopia, Astigmatism, Refractive Error Correction, Children
- Being tested
- Non-cycloplegic Objective refraction, Non-cycloplegic conventional subjective refraction, Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™), Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™), Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)
- Keywords
- cycloplegic refraction, non-cycloplegic refraction, subjective refraction
- Medical subject headings
- Refractive Errors, Hyperopia, Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-cycloplegic Objective refractionDevice
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia
Non-cycloplegic conventional subjective refractionDevice
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)Device
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)Device
Performed with Vision-S™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)Device
Performed with Vision-R™
Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)Device
Performed with Vision-S™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)Device
Performed with Vision-R™
Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)Device
Performed with Vision-S™
Cycloplegic Objective refractionDevice
Objective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia
Non-cycloplegic RetinoscopyDevice
Performed with a retinoscope without cycloplegia
Cycloplegic retinoscopyDevice
Performed with a retinoscope with cycloplegia
| Study group | Role | What they receive |
|---|---|---|
| Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter | Active comparator | Measurement of the non-cycloplegic refraction with Vision-R™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-R™ phoropter and comparison with non-cycloplegic refraction with Vision-R™ phoropter. Receives: Device: Non-cycloplegic Objective refraction; Device: Non-cycloplegic conventional subjective refraction; Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™); Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™); Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™); Device: Cycloplegic Objective refraction; Device: Non-cycloplegic Retinoscopy; Device: Cycloplegic retinoscopy |
| Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter | Active comparator | Measurement of the non-cycloplegic refraction with Vision-S™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-S™ phoropter and comparison with non-cycloplegic refraction with Vision-S™ phoropter. Receives: Device: Non-cycloplegic Objective refraction; Device: Non-cycloplegic conventional subjective refraction; Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™); Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™); Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™); Device: Cycloplegic Objective refraction; Device: Non-cycloplegic Retinoscopy; Device: Cycloplegic retinoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Measured: Day 1
Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Measured: Day 1
Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Indicates the orientation of the Cylinder, measured in degrees (°)
Measured: Day 1
Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Measured: Six months after Day 1
Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Measured: Six months after Day 1
Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Indicates the orientation of the Cylinder, measured in degrees (°)
Measured: Six months after Day 1
Subjective Sphere (with conventional method with Vision-R™)
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Measured: Day 1
Subjective Cylinder (with conventional method, with Vision-R™)
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Measured: Day 1
Subjective Axis (with conventional method, with Vision-R™)
Indicates the orientation of the Cylinder, measured in degrees (°)
Measured: Day 1
Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Corrected visual acuity measure with Kids refraction software vA results
Measured: From enrollment (Day 1) to the end of the study at 7,5 months
Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Corrected visual acuity measure with Kids refraction software vB results
Measured: From enrollment (Day 1) to the end of the study at 7,5 months
Visual acuity (with Conventionnal refraction method, with Vision-R™)
Corrected visual acuity measure with Conventionnal refraction method results
Measured: From enrollment (Day 1) to the end of the study at 7,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start23 May 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive AssessmentStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essilor International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Manuel González- Meijome, PhD, Principal investigator, Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046065
- Sponsor's protocol ID
- WS10374
- Other IDs
- CIV-25-03-051757
- Status last verified
- Jun 2025
- First submitted
- 12 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no need to share individual anonymized data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Algorithm-assisted Subjective Refraction Program Dedicated to Children
- ClinicalTrials.gov ID
- NCT07046065
- Acronym / sponsor ID
- WS10374
- Conditions
- Refractive Assessment, Refractive Disorders, Hyperopia and Myopia, Astigmatism, Refractive Error Correction, Children
- Keywords
- cycloplegic refraction, non-cycloplegic refraction, subjective refraction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Essilor InternationalIndustry (pharma, biotech, devices)
- Study start
- 23 May 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software.
Two different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB).
The software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.
Detailed description
The goal of the investigation is to evaluate the accuracy of the Kids refraction software results performed with the phoropters Vision-R™700 and Vision-S™700 compared to the conventional subjective refraction method results performed with Vision-R™700. Phase A of the investigation will focus on the validation of the first version (Kids refraction software vA), and phase B will involve the second version (Kids refraction software vB).
There are two phases in the investigation:
Phase A:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vA (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Phase B:
To evaluate the agreement of the subjective refraction results (Sphere, Cylinder, Axis, VA) between the Kids Refraction software vB with additional attention and cooperation stages (randomization between Vision-R or Vision-S devices) results and a conventional subjective refraction (performed with Vision-R), in a non-cycloplegic condition.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter | Active comparator | Device: Non-cycloplegic Objective refraction, Device: Non-cycloplegic conventional subjective refraction, Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™), Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™), Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™), Device: Cycloplegic Objective refraction, Device: Non-cycloplegic Retinoscopy, Device: Cycloplegic retinoscopyMeasurement of the non-cycloplegic refraction with Vision-R™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-R™ phoropter and comparison with non-cycloplegic refraction with Vision-R™ phoropter. |
| Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter | Active comparator | Device: Non-cycloplegic Objective refraction, Device: Non-cycloplegic conventional subjective refraction, Device: Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™), Device: Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™), Device: Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™), Device: Cycloplegic Objective refraction, Device: Non-cycloplegic Retinoscopy, Device: Cycloplegic retinoscopyMeasurement of the non-cycloplegic refraction with Vision-S™ phoropter and comparison with the conventional refraction measurement method. Measurement of the cycloplegic refraction with Vision-S™ phoropter and comparison with non-cycloplegic refraction with Vision-S™ phoropter. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 6 and 12 years
- Subject able to recognize and name the letters of the Latin alphabet
- Pupillary distance (PD) not less than 49mm
- Distance refractive error for spherical equivalence (SE) within the range of [-6.00 to +6.00 D] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D
- Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
Key exclusion criteria (13 listed)
- Vulnerability of the subject
- Amblyopia
- Strabismus
- Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state
- Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)
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 |
|---|---|---|
| Non-cycloplegic Objective refractionObjective refraction will be measured using an auto-kerato-refractometer/aberrometer without cyclopegia | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter, Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Non-cycloplegic conventional subjective refractionPerformed with Vision-R™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter, Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)Performed with Vision-R™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter |
| Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)Performed with Vision-S™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-R™)Performed with Vision-R™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter |
| Non-cycloplegic subjective refraction (Kids refraction software vB with Vision-S™)Performed with Vision-S™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Cycloplegic subjective refraction (Kids refraction software vA with Vision-R™)Performed with Vision-R™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter |
| Cycloplegic subjective refraction (Kids refraction software vA with Vision-S™)Performed with Vision-S™ | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Cycloplegic Objective refractionObjective refraction will be measured using an auto-kerato-refractometer/aberrometer with cyclopegia | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter, Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Non-cycloplegic RetinoscopyPerformed with a retinoscope without cycloplegia | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter, Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
| Cycloplegic retinoscopyPerformed with a retinoscope with cycloplegia | Device | Validation of the Kids Refraction softwares vA and vB performed with Vision-R™ phoropter, Validation of the Kids Refraction softwares vA and vB performed with Vision-S™ phoropter |
Primary outcome
Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Time frame: Day 1
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Subjective Cylinder (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Time frame: Day 1
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Subjective Axis (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Time frame: Day 1
Indicates the orientation of the Cylinder, measured in degrees (°)
Subjective Sphere (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Time frame: Six months after Day 1
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Subjective Cylinder (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Time frame: Six months after Day 1
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Subjective Axis (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Time frame: Six months after Day 1
Indicates the orientation of the Cylinder, measured in degrees (°)
Subjective Sphere (with conventional method with Vision-R™)
Time frame: Day 1
The term "sphere" means that the correction for myopia or hyperopia is spherical, equal in all meridians of the eye. This indicates the amount of lens power, measured in diopters (D), prescribed to correct myopia or hyperopia.
Subjective Cylinder (with conventional method, with Vision-R™)
Time frame: Day 1
Indicates the amount of lens power for astigmatism, measured in diopters (D) and represents the difference in the greatest and weakest powers of the eye, usually separated by 90 degrees.
Subjective Axis (with conventional method, with Vision-R™)
Time frame: Day 1
Indicates the orientation of the Cylinder, measured in degrees (°)
Visual acuity (with Kids refraction software vA, with Vision-R™ and with Vision-S™)
Time frame: From enrollment (Day 1) to the end of the study at 7,5 months
Corrected visual acuity measure with Kids refraction software vA results
Visual acuity (with Kids refraction software vB, with Vision-R™ and with Vision-S™)
Time frame: From enrollment (Day 1) to the end of the study at 7,5 months
Corrected visual acuity measure with Kids refraction software vB results
Visual acuity (with Conventionnal refraction method, with Vision-R™)
Time frame: From enrollment (Day 1) to the end of the study at 7,5 months
Corrected visual acuity measure with Conventionnal refraction method results
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. There is no need to share individual anonymized data.
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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.
José Manuel González- Meijome, PhD principal investigator
Clinical & Experimental Optometry Research Lab Department of Physics (Optometry) - School of Science University of Minho, 4710-057 Gualtar - Braga (Portugal)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-cycloplegic Objective refraction, Non-cycloplegic conventional subjective refraction and Non-cycloplegic subjective refraction (Kids refraction software vA with Vision-R™) in people with Refractive Assessment and Refractive Disorders, run by Essilor International at 1 site in Portugal.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 1 Jul 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 Portugal. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Júlia Sousa (+351 21 409 60 79, asousa@evidenze.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sphere (with Kids refraction software vA, with Vision-R™ and with Vision-S™) (time frame: Day 1). The study lists 12 primary outcomes in all. 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 1 Jul 2025.