NCT04618510

SEED-LVPEI Myopia Study

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: L.V. Prasad Eye Institute · Academic / Other
• Sex: All
• Age: 7 Years – 15 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Myopia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-12-11
• Primary completion: 2021-08-30
• Completion: 2022-08-30
• First posted: 2020-11-06
• Last updated: 2021-09-24

Locations

1 site across 1 country: India