SEED-LVPEI Myopia Study

Myopia Clinical Trial

— SLIMS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04618510
• Other study ID #: LEC-BHR-P-09-20-511
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 11, 2020
• Est. completion date: August 30, 2022

Study information

• Verified date: September 2021
• Source: L.V. Prasad Eye Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

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
• Single Vision Spectacles
These are the type of glasses that correct vision for a single distance

Locations

Country	Name	City	State
India	Pavan K. Verkicharla	Hyderabad	Telangana

Sponsors (2)

Lead Sponsor	Collaborator
L.V. Prasad Eye Institute	SEED Co. Ltd.

Country where clinical trial is conducted

India, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central refractive error changes	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.	Data will be collected at baseline, 3 months, 6 months and 12 months.
Primary	Axial length changes	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.	Data will be collected at baseline, 3 months, 6 months and 12 months.
Primary	Peripheral refractive error changes	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.	Data will be collected at baseline, 3 months, 6 months and 12 months.
Secondary	Qualitative assessment	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.