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New Spectacle glass films with S.T.O.P technology to help slow down near sightedness (Myopia)in kids aged 6 to 14 years

Spectacle films utilizing S.T.O.P.® technology for slowing down myopia progression in children: A prospective, masked, controlled, randomized, clinical trial. - nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073247
Enrollment
80
Registered
2024-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: Spectacles: The spectacle films will utilize STOP technology for slowing down myopia progression in children Intervention2: Experimental-Intervention 2: Single vision spectacles plus S.

Sponsors

L V Prasad Eye Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Age between 6 – 14 years inclusive at time of enrolment 2.Interested in wearing spectacles for 5 days/week and 6 hours/day 3.Best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (20/25, 6/7.6) or better in each eye. 4.Willing to swap the spectacle lenses as per the study requirements. 5.-5.00 D = spherical equivalent = -0.75 D and sphere component = -0.50 DS. 6.-1.50 DC = astigmatic component = 0 DC. 7.Spherical equivalent anisometropia = 1.00 D

Exclusion criteria

Exclusion criteria: 1.Current or prior use of any form of myopia control strategy. 2. Participant born earlier than 30 weeks or weighed less than 1500gm at birth. 3.Any ocular, systemic or neuro developmental conditions that may influence refractive error. 4.Manifest strabismus. 5.Any known ocular inflammation or infection.

Design outcomes

Primary

MeasureTime frame
Stage 1: To demonstrate superiority in reducing the rate of myopia progression as measured by the change axial length between each test and the control. Stage 3: To compare the rate of myopia progression as measured by axial length between S.T.O.P.® films used with a dynamic optical signal against a static optical signal. Timepoint: 1 month, 4 months, 6 months, 12 months and 18 months—

Secondary

MeasureTime frame
Stage 1: To compare the change in cycloplegic spherical equivalent autorefraction and visual performance (subjective data and visual acuity) between each test and control. Stage 3: To compare the change in cycloplegic spherical equivalent autorefraction and visual performance between S.T.O.P.® films used with a dynamic optical signal against a static optical signal. Timepoint: 42 months—

Countries

India

Contacts

Public ContactMaanila Pajanivelou

L V Prasad Eye Institute

pavanverkicharla@lvpei.org9573465443

Outcome results

None listed

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