Myopia
Conditions
Keywords
adaptation, visual comfort, satisfaction, refractive error
Brief summary
The goal of this clinical trial is to demonstrate that the visual comfort, adaptation, and overall satisfaction associated with the use of the test spectacle lenses are not inferior to those of the control spectacle lenses in myopic children age ≥ 6 years and \< 11 years old, both male and female, with no systemic or ocular anomalies. The main question it aims to answer is: Do children adapt to the test spectacle lenses within the first 1-2 weeks of wear without significant symptoms or complaints? Is the level of visual comfort and overall satisfaction with test spectacle lenses comparable to that of control spectacle lenses during the early adaptation period? Researchers will compare questionnaire responses between participants wearing test lenses and those wearing control lenses to assess whether the test lenses are non-inferior in terms of visual comfort, adaptation, and user satisfaction. Participants will: * Wear the study spectacles for 2 weeks * Respond to questionnaires 4 days after dispensing and at 2 weeks * Visit Essilor R&D Centre for screening, dispensing and follow up sessions
Interventions
DEVICEHADAL Spectacle Lenses
Dispense to Test group for 2 weeks
DEVICEStellest® Spectacle Lenses
Dispense to Control group for 2 weeks
Sponsors
Essilor International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
This is a prospective, parallel-group, monocentre, non-inferiority clinical comparing test lenses with control lenses during which 20 myopic children aged ≥ 6 years and \< 11 years will be enrolled and randomized 1:1 to test group or control group as participants, for a period of 2 weeks.
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Volunteer participant who is willing and able to comply with all scheduled study visits. * Informed consent of parent/guardian and assent of participant. * Age ≥ 6 years and \< 11 years at the time of signing informed consent and assent. * Spherical equivalent refraction (SER) equal or less than -0.50D and equal or greater than -4.75D with astigmatism not more than 2.00 D on both eyes. * Difference in SER (anisometropia) between two eyes should not exceed 1.50 D. * Best corrected Distance Visual Acuity (BCDVA) better than or equal to +0.10 LogMAR in each eye. * Be in good general health, based on the participant and the parent's/guardian's knowledge.
Exclusion criteria
* History of Atropine, Orthokeratology, Contact Lens or Red Light treatment. * Strabismus by cover test at near or distance wearing correction. * History and presence of amblyopia. * Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.). * Current use of ocular or systemic medications which, in the investigator's opinion, may significantly affect pupil size, accommodation or refractive state. * History of ocular injury or surgery. * Participation in any clinical study within 30 days of the Baseline visit. * Sibling of existing participant of this study * Study participants deemed inappropriate for the study by the investigator. * The inherent ocular/systemic discomfort (dry eyes, visual fatigue, headaches, etc.) that may affect the evaluation of the study lens wearing experience, from the investigator's perspective.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Adaptation Rate Within 1 Week After Dispensing | Within 1 week post dispensing | Proportion of children who meet all of the following criteria at the 1-week visit: 1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire 2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the 4-day visit, as assessed through the symptom checklist in the study questionnaire 3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the 1-week visit. Non-inferiority of the test lenses will be evaluated against the control lenses based on the between-group difference in adaptation success rates, using a pre-specified non-inferiority margin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Adaptation Rates at Early and Later Timepoints | 4 days and 2 weeks post-dispensing | Proportion of children who meet all of the following criteria at approximately Day 4 and Week 2 post-dispensing: 1. Self-reported adaptation: The child confirms feeling adapted to the assigned study lenses, as captured by a pre-specified question in the study questionnaire 2. Absence or resolution of symptoms: The child reports either (i) no symptoms since dispensing, or (ii) complete resolution of any symptoms initially reported at the previous visit, as assessed through the symptom checklist in the study questionnaire 3. No lens discontinuation: The child has not discontinued wear of the assigned study lenses prior to the respective visit Between-group differences in adaptation success rates between the test and control spectacle lenses will be evaluated at both timepoints. |
| Average daily and weekly wearing time | Assessed at Day 4 and Week 2 post-dispensing | Mean daily wearing time (hours/day) and total weekly wearing time (hours/week) of the assigned study spectacles will be compared between the test and control groups, based on participant/parent-reported wear time. |
| Activity-specific visual comfort | 4 days and 2 weeks post-dispensing | Participant-reported visual comfort during daily activities (including far vision, intermediate vision, near vision with and without digital devices, and overall vision) will be evaluated using the specific comfort subscale items from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual comfort items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded comfort questions are reverse-coded prior to analysis so that all values are directionally aligned. The subscale score is calculated as the mean of these items, yielding a minimum value of 1 and a maximum value of 4, where a higher score indicates a better outcome (greater visual comfort during daily activities). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint. |
| Overall satisfaction | 4 days and 2 weeks post-dispensing | Overall satisfaction with the study spectacles will be evaluated using the satisfaction subscale items (e.g., "I hate wearing the new spectacles" and "I like my new spectacles") from the unabbreviated Visual Comfort and Adaptation Questionnaire (Child). Individual items are rated on a 4-point Likert scale ranging from 1 (Strongly disagree) to 4 (Strongly agree). Negatively worded items are reverse-coded during data analysis. Subscale scores are calculated as the mean of the items, ranging from a minimum value of 1 to a maximum value of 4, where higher scores indicate a better outcome (higher satisfaction with the spectacles). Between-group differences between the test and control spectacle lenses will be evaluated at each specified timepoint. |
| High-contrast visual acuity (distance and near) | At dispensing (baseline) and 2 weeks post-dispensing | Monocular and binocular high-contrast visual acuity at distance and near, measured while wearing study spectacles, will be compared between the test and control groups. |
Contacts
CONTACTCeline Carimalo
CONTACTThomas Boudenne
PRINCIPAL_INVESTIGATORSheron Quak
Essilor R&D Centre Singapore
Outcome results
None listed