NCT04618510

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. 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. 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. 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. 4.To investigate the qualitative assessment of comfort and visual experience with the SEED's EDOF contact lenses through the questionnaire method.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

December 11, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

September 24, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

October 27, 2020

Last Update Submit

September 23, 2021

Conditions

Myopia

Keywords

MyopiaContact LensPeripheral DefocusMulti-focalIndiaExtended Depth of Focus

Outcome Measures

Primary Outcomes (3)

  • Central refractive error changes

    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.

    Data will be collected at baseline, 3 months, 6 months and 12 months.

  • Axial length changes

    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.

    Data will be collected at baseline, 3 months, 6 months and 12 months.

  • Peripheral refractive error changes

    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.

    Data will be collected at baseline, 3 months, 6 months and 12 months.

Secondary Outcomes (1)

  • Qualitative assessment

    Data will be collected at 3 months, 6 months and 12 months.

Study Arms (2)

SEED 1-dayPure EDOF soft contact lens

EXPERIMENTAL

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

Single vision spectacle lens

SHAM COMPARATOR

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

Interventions

SEED 1-dayPure EDOF soft contact lensDEVICE

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

SEED 1-dayPure EDOF soft contact lens
Single Vision SpectaclesDEVICE

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

Single vision spectacle lens

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pavan K. Verkicharla

Hyderabad, Telangana, 500034, India

Location

Related Publications (4)

  • Sankaridurg P, Holden B, Smith E 3rd, Naduvilath T, Chen X, de la Jara PL, Martinez A, Kwan J, Ho A, Frick K, Ge J. Decrease in rate of myopia progression with a contact lens designed to reduce relative peripheral hyperopia: one-year results. Invest Ophthalmol Vis Sci. 2011 Dec 9;52(13):9362-7. doi: 10.1167/iovs.11-7260.

    PMID: 22039230BACKGROUND

  • Bakaraju RC, Ehrmann K, Ho A. Extended depth of focus contact lenses vs. two commercial multifocals: Part 1. Optical performance evaluation via computed through-focus retinal image quality metrics. J Optom. 2018 Jan-Mar;11(1):10-20. doi: 10.1016/j.optom.2017.04.003. Epub 2017 Jun 9.

    PMID: 28606456BACKGROUND

  • Bakaraju RC, Tilia D, Sha J, Diec J, Chung J, Kho D, Delaney S, Munro A, Thomas V. Extended depth of focus contact lenses vs. two commercial multifocals: Part 2. Visual performance after 1 week of lens wear. J Optom. 2018 Jan-Mar;11(1):21-32. doi: 10.1016/j.optom.2017.04.001. Epub 2017 Jun 12.

    PMID: 28619486BACKGROUND

  • Sankaridurg P, Bakaraju RC, Naduvilath T, Chen X, Weng R, Tilia D, Xu P, Li W, Conrad F, Smith EL 3rd, Ehrmann K. Myopia control with novel central and peripheral plus contact lenses and extended depth of focus contact lenses: 2 year results from a randomised clinical trial. Ophthalmic Physiol Opt. 2019 Jul;39(4):294-307. doi: 10.1111/opo.12621. Epub 2019 Jun 10.

    PMID: 31180155BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Pavan K Verkicharla, PhD

    L.V. Prasad Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single Masked Randomized Study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientist-Myopia Research Lab

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 6, 2020

Study Start

December 11, 2020

Primary Completion

August 30, 2021

Study Completion

August 30, 2022

Last Updated

September 24, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)