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SEED-LVPEI Myopia Study

Efficacy of SEEDâ??s novel anti-myopia contact lens (daily disposable) in controlling myopia progression-Randomized Control Clinical Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030839
Enrollment
150
Registered
2021-01-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 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 1
3 months, 6 months, 12 months) post contact lens wear. Control Intervention1: Single vision spectacle lens: The participant will be requested to wear the spectacle lens daily. All participants will be
3 months, 6 months, 12 months) post spectacle lens wear.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: 1.Myopia (SE) between -0.50D to -10.00D 2.Astigmatism less than 0.75D 3.Anisometropia less than 1.00D 4.Age of the participant from 7 to 15 years 5.Neophyte or existing soft contact lens wearer 6.Best corrected visual acuity (BCVA); 7.Participants who are willing to wear the contact lens constantly

Exclusion criteria

Exclusion criteria: 1.Participants who had any ocular or systemic conditions that could influence the refractive error 2.Poor compliance of contact lenses from the existing wearer 3.Prior use of orthokeratology lenses/bifocal lenses/anti-myopia strategies 4.Participants who had any medications that could influence the refractive error

Design outcomes

Primary

MeasureTime frame
1. Changes (1 year) in spherical equivalent refractive error and axial length (mm) in the intervention and control group from the baseline. 2. Changes (1 year) in peripheral refraction (spherical equivalent) of the individuals in the intervention and control group from the baseline. 3. Changes (1 year) in axial length (mm), central and peripheral refractive error (spherical equivalent) among different degrees of myopia in the intervention and control group from the baseline. Timepoint: 3 months, 6 months, 12 months

Secondary

MeasureTime frame
1. Qualitative assessment of comfort and visual experience with SEED 1 dayPure EDOF lenses through the questionnaire method.Timepoint: 3 months, 6 months, 12 months

Countries

India

Contacts

Public ContactDr Pavan K Verkicharla

L V Prasad Eye Institute

pavanverkicharla@lvpei.org9573465443

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026