SEED-LVPEI Myopia Study (SLIMS)

September 23, 2021 updated by: Dr. Pavan Verkicharla, L.V. Prasad Eye Institute

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Pavan K. Verkicharla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Sham Comparator: Single vision spectacle lens
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
These are the type of glasses that correct vision for a single distance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Central refractive error changes
Time Frame: 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.
Data will be collected at baseline, 3 months, 6 months and 12 months.
Axial length changes
Time Frame: 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.
Data will be collected at baseline, 3 months, 6 months and 12 months.
Peripheral refractive error changes
Time Frame: 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.
Data will be collected at baseline, 3 months, 6 months and 12 months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L.V. Prasad Eye Institute

Collaborators

SEED Co. Ltd.

Investigators

  • Principal Investigator: Pavan K Verkicharla, PhD, L.V. Prasad Eye Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Actual)

August 30, 2021

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 31, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEC-BHR-P-09-20-511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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