SEED-LVPEI Myopia Study

Study Overview
=================
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: 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. 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. 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). 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.

Official Title
-----------------
Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: SEED 1-dayPure EDOF soft contact lens
* Device: Single Vision Spectacles


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEED 1-dayPure EDOF soft contact lens<br>The participant will be requested to wear the daily disposable lens 8-10 hours per day and replaced daily. All participants will be followed for 12 months (followup visit schedule; 3 months, 6 months, 12 months) post-contact lens wear. | Device: SEED 1-dayPure EDOF soft contact lens<br>* Centre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia<br>|
| Sham Comparator: Single vision spectacle lens<br>The participant will be requested to wear the spectacle lens daily. All participants will be followed for 12 months (follow up visit schedule; 3 months, 6 months, 12 months) post spectacle lens wear. | Device: Single Vision Spectacles<br>* These are the type of glasses that correct vision for a single distance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central refractive error changes | Changes (1 year) in spherical equivalent refractive error (dioptre) in the intervention and control group from the baseline. Changes (1 year) in spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline. | Data will be collected at baseline, 3 months, 6 months and 12 months. | 
| Axial length changes | Changes (1 year) in axial length (millimetre) in the intervention and control group from the baseline. Changes (1 year) in axial length (millimetre) among different degrees of myopia in the intervention and control group from the baseline. | Data will be collected at baseline, 3 months, 6 months and 12 months. | 
| Peripheral refractive error changes | Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) of the individuals in the intervention and control group from the baseline. Changes (1 year) in peripheral spherical equivalent refractive error (dioptre) among different degrees of myopia in the intervention and control group from the baseline. | Data will be collected at baseline, 3 months, 6 months and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment | 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). | Data will be collected at 3 months, 6 months and 12 months. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myopia, Contact Lens, Peripheral Defocus, Multi-focal, India, Extended Depth of Focus