Actively Recruiting

Phase Not Applicable
Age: 7Years - 15Years
All Genders
NCT06878118

The A.R.R.E.S.T.® Contact Lens Study

Led by nthalmic Pty Ltd · Updated on 2025-10-03

80

Participants Needed

2

Research Sites

69 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn if contact lenses using Active Reconfiguration in Retinal Encoding of Spatio-Temporal (A.R.R.E.S.T.®) signal technology works to slow down the rate of myopia progression compared to single vision contact lenses in myopic children. The main questions it aims to answer are: Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of axial length growth? Do contact lenses using A.R.R.E.S.T.® technology slow down the rate of increase in myopic refractive error? Researchers will compare contact lenses using A.R.R.E.S.T.® technology to a single vision contact lens. Participants will: Be randomly allocated to wear either contact lenses using A.R.R.E.S.T.® technology or single vision contact lenses. Visit the clinic on seven occasions over a 12 month period.

CONDITIONS

Official Title

The A.R.R.E.S.T.® Contact Lens Study

Who Can Participate

Age: 7Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be between 7 to 15 years old inclusive at time of enrolment.
  • Have read, understood, and signed the Informed Assent.
  • Have parent or legal guardian who has read, understood, and signed the Informed Consent.
  • Along with parent/guardian, be capable of understanding the study and willing to follow requirements.
  • Agree to maintain visit schedule and prescribed contact lens wearing schedule.
  • Agree to wear study contact lenses at least 5 days per week, 6 hours per day but not more than 16 hours, removing lenses at night.
  • Be in good general health according to parent/guardian.
  • Have best-corrected visual acuity of 0.10 logMAR (20/25) or better in each eye.
  • Have cycloplegic autorefraction at baseline with spherical equivalent between -4.00 D and 0.75 D.
  • Have astigmatism between -1.00 DC and 0 DC, or meet subjective refraction astigmatism criteria if autorefraction fails.
  • Have spherical equivalent anisometropia of 1.00 D or less.
Not Eligible

You will not qualify if you...

  • Participated in another study within 30 days prior to this study.
  • Current or prior use of myopia control interventions such as bifocal/multifocal spectacles or contact lenses, or orthokeratology.
  • Use of atropine eye drops greater than 0.01% concentration; previous use of 0.01% atropine allowed if stopped 30 days before baseline and during study.
  • Born earlier than 30 weeks gestation or birth weight less than 1500 g.
  • Use of systemic or topical medications affecting eye health at enrolment or during study.
  • Allergy to sodium fluorescein, benoxinate, proparacaine, tropicamide, or cyclopentolate.
  • Eye conditions such as corneal hypoesthesia, corneal ulcers, viral or fungal infections, or recurrent ocular infections.
  • Strabismus determined by cover test at distance or near while wearing correction.
  • Known ocular or systemic diseases like diabetes, Graves' disease, glaucoma, uveitis, scleritis, autoimmune diseases, or neuro-developmental conditions affecting vision.
  • Biomicroscopic findings contraindicating contact lens wear such as neovascularisation, active anterior segment disease, giant papillary conjunctivitis, or significant abnormalities of eye structures.
  • Allergic or seasonal conjunctivitis interfering with lens wear.
  • Investigator discretion to exclude participants unable to fulfill study requirements or for participant safety.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

2

Optometry Clinic, Faculty of Health Science, Universiti Kebangsaan Malaysia

Kuala Lumpur, Malaysia, 50300

Actively Recruiting

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Research Team

D

Daniel Tilia, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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