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New treatment option for Refractive Assessment
Official title Algorithm-assisted Subjective Refraction Program Dedicated to Children
ClinicalTrials.gov ID: NCT07046065
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 12. Healthy volunteers may be eligible.
You may be able to join if
- 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 ≤...
- Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance
You likely can't join if
- 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.)
See the full eligibility criteria
- 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
- 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.)
- 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). -
The study team makes the final eligibility decision.
Where it's taking place
- Vila Nova de Famalicão, Portugal
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 12 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vila Nova de Famalicão, Portugal. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.