The P.A.U.S.E.® Spectacle Study

NCT06577948 | Active Not Recruiting

• 1 other identifier: nthal2024-01
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if spectacle lenses using Phase Alteration Utilising Sub Elements (P.A.U.S.E.®) technology works to slow down the rate of myopia progression in myopic children. The first stage of the trial compares P.A.U.S.E.® spectacle lenses to single vision spectacle lenses in myopic children and the second stage looks at the rate of myopia progression in children while wearing P.A.U.S.E.® spectacle lenses. The main questions to answer are: Do P.A.U.S.E.® spectacle lenses slow down the rate of axial length growth? Do P.A.U.S.E.® spectacle lenses slow down the rate of increase in myopic refractive error? Researchers will compare P.A.U.S.E.® spectacle lenses to a single vision spectacle lens for 12 months followed by assessing P.A.U.S.E.® spectacle lenses for slowing down myopia progression for another 12 months. Participants will be initially randomly allocated to wear either P.A.U.S.E.® spectacle lenses or single vision spectacle lenses and visit the clinic on five occasions over the first 12 month period. After completing the first 12 months, all participants will wear P.A.U.S.E.® spectacle lenses and visit the clinic on three occasions over the second 12 month period.

Conditions

Myopia

Keywords

axial length; spherical equivalent cycloplegic autorefraction

Outcome Measures

Primary Outcomes (1)

• Axial Length

  Difference in change from Stage 1 dispensing in axial length between each test and control. The change in axial length from the Stage 2 dispensing.

  Stage 1: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Stage 1 Dispensing Visit. Stage 2: Dispensing Visit (up to 26 days from Stage 1: 12 months), then 6 months and 12 months after Stage 2 Dispensing Visit.

Secondary Outcomes (3)

• Cycloplegic spherical equivalent autorefraction

  Stage 1: Baseline, then 6 months and 12 months after Stage 1 Dispensing Visit (up to 26 days from Baseline). Stage 2: Stage 1: 12 months visit, then 6 months and 12 months after Stage 2 Dispensing Visit (up to 26 days from Stage1: 12 months visit).

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

  Stage 1: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit Stage 2: Dispensing Visit (up to 26 days from Stage 2: 12 month), then 6 months, and 12 months after Dispensing Visit

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

  Stage 1: Dispensing Visit (up to 26 days from Baseline), then 1 month, 6 months, and 12 months after Dispensing Visit. Stage 2: Dispensing Visit (up to 26 days from Stage 2: 12 month), then 6 months, and 12 months after Dispensing Visit.

Study Arms (3)

Assigned Intervention 1

ACTIVE COMPARATOR

Single vision spectacle lens

Device: Single vision spectacle lens

Assigned Intervention 2

EXPERIMENTAL

P.A.U.S.E. spectacle lens 1

Device: P.A.U.S.E. spectacle lens 1

Assigned Intervention 3

EXPERIMENTAL

P.A.U.S.E. spectacle lens 2

Device: P.A.U.S.E. spectacle lens 2

Interventions

Single vision spectacle lens DEVICE

Standard single vision spectacle lens

Assigned Intervention 1

P.A.U.S.E. spectacle lens 1 DEVICE

P.A.U.S.E. spectacle lens 1

Assigned Intervention 2

P.A.U.S.E. spectacle lens 2 DEVICE

P.A.U.S.E. spectacle lens 2

Assigned Intervention 3

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.
• Be in good general health, based on the parent's / legal guardian's knowledge.

You may not qualify if:

• Participant is currently an active participant in another study or was active participant in another study within 30 days prior to this study.
• Current or prior use of interventions intended for myopia control, including but not limited to:
• Optical devices:
• Bifocal / multifocal spectacles.
• Bifocal / multifocal contact lenses.
• Orthokeratology.
• 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.
• o 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.

Sponsors & Collaborators

• nthalmic Pty Ltd: lead
• Brighten Optix Corporation: collaborator

Study Sites (1)

Hai Yen Eye Care

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Daniel Tilia, MOptom, PhD

  nthalmic Pty Lyd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Investigators, participants, and parents/legal guardians will be masked to the identity of the study product worn by each participant. All spectacle lenses will be fitted into the chosen spectacle frame. P.A.U.S.E.® optical elements may be visible under certain lighting conditions, and therefore, it may not be possible to completely mask test spectacle lenses from control spectacle lenses. However, complete masking is possible between test spectacle lenses. Regardless, investigators who perform crucial measurements (axial length and autorefraction) should not view a participant's study product to further minimise the chance of de masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Research Optometrist

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: September 14, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)