SLIMS: SEED-LVPEI Myopia Study

Sponsor
L.V. Prasad Eye Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04618510
Collaborator
SEED Co. Ltd. (Other)
108
1
2
20.6
5.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SEED 1-dayPure EDOF soft contact lens
  • Device: Single Vision Spectacles
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single Masked Randomized Study
Primary Purpose:
Treatment
Official Title:
Efficacy of SEED's Novel Anti-myopia Contact Lens (Daily Disposable) in Controlling Myopia Progression
Actual Study Start Date :
Dec 11, 2020
Actual Primary Completion Date :
Aug 30, 2021
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Central refractive error changes [Data will be collected at baseline, 3 months, 6 months and 12 months.]

    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.

  2. Axial length changes [Data will be collected at baseline, 3 months, 6 months and 12 months.]

    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.

  3. Peripheral refractive error changes [Data will be collected at baseline, 3 months, 6 months and 12 months.]

    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.

Secondary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pavan K. Verkicharla Hyderabad Telangana India 500034

Sponsors and Collaborators

  • L.V. Prasad Eye Institute
  • SEED Co. Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Pavan Verkicharla, Scientist-Myopia Research Lab, L.V. Prasad Eye Institute
ClinicalTrials.gov Identifier:
NCT04618510
Other Study ID Numbers:
  • LEC-BHR-P-09-20-511
First Posted:
Nov 6, 2020
Last Update Posted:
Sep 24, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Pavan Verkicharla, Scientist-Myopia Research Lab, L.V. Prasad Eye Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 24, 2021