Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children

NCT06137560 | Recruiting

• 1 other identifier: nthal2021-04
• Study Type: interventional
• Target: 210
• Locations: 2 countries
• Sites: 5

Brief Summary

There are two parts to this trial. First, to compare the rate of myopia progression of spectacle films using Spatio Temporal Optic Phase (S.T.O.P.®) technology that provide a dynamic optical cue against single vision spectacle lenses. Second, to compare the rate of myopia progression of spectacle films using S.T.O.P.® technology that provide a dynamic optical cue against spectacle films using S.T.O.P.® technology that provide a static optical cue. A dynamic optical cue is one that changes, and a static optical cue is one that does not change.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• Axial length

  Difference in change from Baseline in axial length between single vision (control) and S.T.O.P.® Kit 1 \& 2 (tests)

  Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense

• Axial length

  Difference in change from Second Dispense in axial length between static optical cue (control) and dynamic optical cue (test)

  Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense

Secondary Outcomes (6)

• Cycloplegic spherical equivalent autorefraction

  Baseline, First Dispense (up to 26 days from Baseline), then 1 month, 4 months, and 6 months after First Dispense

• Cycloplegic spherical equivalent autorefraction

  Second Dispense (up to 392 days from Baseline), then 6 months, 12 months, and 18 months after Second Dispense

• Visual performance as measured by high contrast visual acuity at 6 m

  1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)

• Visual performance as measured by high contrast visual acuity at 6 m

  6 months, 12 months, and 18 months after Second Dispense (up to 392 days from Baseline)

• Visual performance as measured by a non validated questionnaire based on a 1-10

  1 month, 4 months, and 6 months after First Dispense (up to 26 days from Baseline)

Study Arms (5)

Assigned Intervention 1

ACTIVE COMPARATOR

Single vision spectacle lens

Device: Single vision spectacle lens

Assigned Intervention 2

EXPERIMENTAL

Single vision spectacle lens + S.T.O.P.® Kit 1

Device: Single vision spectacle lens + S.T.O.P.® Kit 1

Assigned Intervention 3

EXPERIMENTAL

Single vision spectacle lens + S.T.O.P.® Kit 2

Device: Single vision spectacle lens + S.T.O.P.® Kit 2

Assigned Intervention 4

ACTIVE COMPARATOR

Static optical signal: single vision spectacle lens + S.T.O.P.® spectacle film

Device: Single vision spectacle lens + S.T.O.P.® Film

Assigned Intervention 5

EXPERIMENTAL

Dynamic optical signal: single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Device: Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Interventions

Single vision spectacle lens DEVICE

Standard single vision spectacle lens

Assigned Intervention 1

Single vision spectacle lens + S.T.O.P.® Kit 1 DEVICE

Standard single vision spectacle lens + S.T.O.P.® Kit 1

Assigned Intervention 2

Single vision spectacle lens + S.T.O.P.® Kit 2 DEVICE

Standard single vision spectacle lens + S.T.O.P.® Kit 2

Assigned Intervention 3

Single vision spectacle lens + S.T.O.P.® Film DEVICE

Standard single vision spectacle lens + S.T.O.P.® Film

Assigned Intervention 4

Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2 DEVICE

Standard single vision spectacle lens + S.T.O.P.® Kit 1 or 2

Assigned Intervention 5

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be between 6-14 years inclusive at time of enrolment.
• Have:
• Read the Informed Assent.
• Been explained the Informed Assent.
• Indicated an understanding of the Informed Assent.
• Signed the Informed Assent.
• Have their parent / legal guardian:
• Read the Informed Consent.
• Been explained the Informed Consent.
• Indicated an understanding of the Informed Consent.
• Signed the Informed Consent.
• Along with their parent / legal guardian, be capable of comprehending the nature of the study, and be willing and able to adhere to study requirements.
• Along with their parent / legal guardian, agree to maintain the visit and prescribed wearing schedule.
• Agree to wear allocated spectacles for a minimum of 5 days per week, at least 6 hours per day for the duration of the study and to inform the investigator if their schedule is interrupted.
• Possess wearable and visually functioning spectacles.

You may not qualify if:

• Participant is currently, or within 30 days prior to this study, has been an active participant in another study.
• Current or prior use of ANY form of myopia control, including but not limited to:
• Optical devices:
• Bifocal or multifocal spectacles of any type.
• Bifocal or multifocal contact lenses of any type.
• Orthokeratology of any type.
• Pharmacological agents:
• Atropine with a concentration \> 0.01%. Participants who have previously used 0.01% atropine are eligible for this study provided they agree not to use 0.01% atropine for at least 30 days before baseline and at any time during the study.
• Pirenzepine
• Participant born earlier than 30 weeks or weighed \< 1500 g at birth.
• A verbal report from the participant's parent / legal guardian is sufficient.
• Habitual use of a systemic or topical medication that may alter normal ocular findings / is known to affect a participant's ocular health / physiology either in an adverse or beneficial manner at enrolment and / or during the clinical trial.
• A known allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
• Strabismus as determined by cover test at distance (≥ 3 m) or near (40 cm) while wearing distance correction under non-cycloplegic conditions.
• Known ocular or systemic disease, such as but not limited to:

Sponsors & Collaborators

• nthalmic Pty Ltd: lead
• Zhong Jing Wei Shi (Suzhou) Optical Technology Ltd.: collaborator

Study Sites (5)

Tianjin Eye Hospital

Tianjin, Heping District, 300020, China

RECRUITING

Shanghai Fudan University Eye and ENT Hospital

Shanghai, Xuhui District, 200031, China

RECRUITING

Divyajyoti Trust Tejas Eye Hospital

Surat, Gujarat, 394 160, India

RECRUITING

LV Prasad Eye Institute

Hyderabad, Telangana, 500034, India

RECRUITING

Pristine Eye Hospitals

Hyderabad, Telangana, 500081, India

NOT YET RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Daniel Tilia, Optom, PhD

  nthalmic Pty Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Tilia, MOptom, PhD

CONTACT

+6129037700; d.tilia@nthalmic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Optometrist

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: December 22, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2); IN (3)