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SEED-LVPEI Myopia Study

NCT04618510 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2021-09-24

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DEVICE

SEED 1-dayPure EDOF soft contact lens

Centre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia

DEVICE

Single Vision Spectacles

These are the type of glasses that correct vision for a single distance

Sponsors & Collaborators

  • SEED Co. Ltd.

    collaborator UNKNOWN

  • L.V. Prasad Eye Institute

    lead OTHER

Principal Investigators

  • Pavan K Verkicharla, PhD · L.V. Prasad Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-11
Primary Completion
2021-08-30
Completion
2022-08-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04618510 on ClinicalTrials.gov