Myopia
Conditions
Keywords
Myopia, Contact Lens, Peripheral Defocus, Multi-focal, India, Extended Depth of Focus
Brief summary
This randomized clinical trial study aims to investigate the efficacy of novel SEED's EDOF based mid-lens design in controlling the myopia progression in Indian children with these specific objectives: 1. To investigate the efficacy of SEED's 1-day pure extended depth of focus lenses controlling myopia progression in Indian children through a one-year randomized clinical study. 2. To investigate the role of SEED's 1-day pure extended depth of focus lenses in altering peripheral refraction of the eye to control myopia progression. 3. To determine if there is any specific cohort that shows better efficacy in myopia control with 1-day pure extended depth of focus lenses based on central and peripheral optics (degree of myopia and optical parameters). 4. To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.
Detailed description
This prospective randomized controlled clinical trial will be conducted in Myopia Research Lab, L V Prasad Eye Institute, Hyderabad and the study protocol will adhere to the tenets of the Declaration of Helsinki. Participants will be recruited through advertisements in local print media (newspaper), approaching schools, through clinical referrals. Children will be assigned to either the control group or intervention group randomly based on computer-generated random numbers operated by the investigator. All participants will undergo a cycloplegic refractive error assessment after the instillation of tropicamide 1% eye drops (or cyclopentolate 1% eye drops in case of varying refractive error between objective and subjective values). Axial length and cycloplegic refractive measurements will be taken with using Lenstar LS900 biometer and Shin- Nippon autorefractor respectively for scheduled follow up and will be compared with the baseline parameters.
Interventions
DEVICESEED 1-dayPure EDOF soft contact lens
Centre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia
DEVICESingle Vision Spectacles
These are the type of glasses that correct vision for a single distance
Sponsors
SEED Co. Ltd.
L.V. Prasad Eye Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single Masked Randomized Study
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
* Myopia (SE) between -0.50D to -10.00D * Astigmatism less than 0.75D * Anisometropia less than 1.00D * Age of the participant from 7 to 15 years * Neophyte or existing soft contact lens wearer * Best-corrected visual acuity (BCVA); ≤ 20/20 * Participants who are willing to wear the contact lens constantly
Exclusion criteria
* Participants who had any ocular or systemic conditions that could influence the refractive error * Poor compliance of contact lenses from existing wearer * Prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies * Participants who had any medications that could influence the refractive error
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central refractive error changes | Data will be collected at baseline, 3 months, 6 months and 12 months. | 1. Changes (1 year) in spherical equivalent refractive error (dioptre) in the intervention and control group from the baseline. 2. Changes (1 year) in spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline. |
| Axial length changes | Data will be collected at baseline, 3 months, 6 months and 12 months. | 1. Changes (1 year) in axial length (millimetre) in the intervention and control group from the baseline. 2. Changes (1 year) in axial length (millimetre) among different degrees of myopia in the intervention and control group from the baseline. |
| Peripheral refractive error changes | Data will be collected at baseline, 3 months, 6 months and 12 months. | 1. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) of the individuals in the intervention and control group from the baseline. 2. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment | Data will be collected at 3 months, 6 months and 12 months. | Qualitative assessment of discomfort and visual experience of centre-distance multifocal contact lens will be measured on a scale of 0-4 (0=Never, 1=Rarely, 2=Sometimes, 3=Often, 4=Always). |
Countries
India
Outcome results
None listed