SEED-LVPEI Myopia Study

Not Applicable

• Conditions: Myopia
• Interventions: Device: SEED 1-dayPure EDOF soft contact lens; Device: Single Vision Spectacles

• Registration Number: NCT04618510
• Lead Sponsor: L.V. Prasad Eye Institute

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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-31
• Study First Posted: 2020-11-06
• Study Start: 2020-12-11
• Primary Completion: 2021-08-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEED 1-dayPure EDOF soft contact lens	SEED 1-dayPure EDOF soft contact lens	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.
Single vision spectacle lens	Single Vision Spectacles	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Pavan K. Verkicharla; 🇮🇳 Hyderabad, Telangana, India