The P.A.U.S.E.® Spectacle Study

NCT ID: NCT06577948

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-14
• Study Completion Date: 2026-03-31

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 compared to single vision spectacle lenses in myopic children. The main questions it aims to answer are:

Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of axial length growth? Do spectacle lenses using P.A.U.S.E.® technology slow down the rate of increase in myopic refractive error?

Researchers will compare spectacle lenses using P.A.U.S.E.® technology to a single vision spectacle lens.

Participants will:

Be randomly allocated to wear either spectacle lenses using P.A.U.S.E.® technology or single vision spectacle lenses.

Visit the clinic on five occasions over a 12 month period.

Detailed Description

The aim of this clinical trial is to compare the rate of myopia progression as measured by change from the Dispensing visit (up to 26 days from Baseline), in axial length and the change from Baseline in the spherical equivalent cycloplegic autorefraction between two spectacle lens designs using P.A.U.S.E.® technology (tests) and single vision spectacle lenses ( control). Myopic children (6-14 years of age) will be randomly allocated to wear either test 1, test 2, or control.

The overall trial duration, including follow-up period, is expected to be approximately 18 months. Each participant's duration is expected to be approximately 12 months.

The visits are Baseline, Dispensing, 1 month, 6 months, and 12 months.

All procedures performed at these visits are standard, non invasive clinical tests.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Assigned Intervention 1

Single vision spectacle lens

Group Type: ACTIVE_COMPARATOR

Single vision spectacle lens

Intervention Type: DEVICE

Standard single vision spectacle lens

Assigned Intervention 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Assigned Intervention 3

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

Single vision spectacle lens

Standard single vision spectacle lens

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

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

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.
• Have best-corrected high contrast visual acuity based on manifest refraction of 0.10 logMAR (Snellen: 20/25, 6/7.6; Decimal: 0.8) or better in each eye.
• Meet the following criteria determined by cycloplegic autorefraction at Baseline:

o-5.00 D ≤ spherical equivalent ≤ -0.75 D and sphere component ≤ -0.50 DS. o-1.50 DC ≤ astigmatic component ≤ 0 DC. o|Spherical equivalent anisometropia| ≤ 1.00 D.

Exclusion Criteria

• 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.
• Known ocular or systemic disease, such as but not limited to:

• Diabetes.
• Graves' disease.
• Glaucoma.
• Uveitis.
• Scleritis.
• Auto-immune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren's syndrome, and systemic lupus erythematosus.
• Any ocular, systemic, or neuro-developmental conditions that could influence refractive development, such as but not limited to:

• Persistent pupillary membrane.
• Vitreous haemorrhage.
• Cataract.
• Central corneal scarring.
• Eyelid haemangiomas.
• Marfan's syndrome.
• Down's syndrome.
• Ehler's-Danlos syndrome.
• Stickler's syndrome.
• Ocular albinism.
• Retinopathy of prematurity.
• Keratoconus or irregular cornea.
• The investigator may, at their discretion, exclude anyone who they believe may not be able to fulfil the clinical trial requirements or it is believed to be in the participant's best interests.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brighten Optix Corporation

UNKNOWN

Sponsor Role: collaborator

nthalmic Pty Ltd

NETWORK

Sponsor Role: lead

Responsible Party

Daniel Tilia, MOptom, PhD

Principal Research Optometrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Tilia, MOptom, PhD

Role: PRINCIPAL_INVESTIGATOR

nthalmic Pty Lyd

Locations

Hai Yen Eye Care

Ho Chi Minh City, , Vietnam

Site Status: RECRUITING

Countries

Vietnam

Central Contacts

Daniel Tilia, MOptom, PhD

Role: CONTACT

pandatrials@nthalmic.com

6129037700

Facility Contacts

Minh Huy Tran Dinh, MD. PhD.

Role: primary

minhhuy.trandinh@gmail.com

84907110892

Other Identifiers

nthal2024-01

Identifier Type: -

Identifier Source: org_study_id