Behavioural Intervention

Specialized Contact Lenses for Nearsightedness (WINK Trial)

Birmingham, AL

N/A

Waitlist Available

Led By Safal Khanal, OD, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willingness to wear the lenses for a minimum of 10 hours/day, at least six days a week for the duration of the study

Be younger than 18 years old

Must not have

Contact lens contraindications (e.g., giant papillary keratoconjunctivitis)

Corneal disorders (e.g., hypoesthesia, keratoconus)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Summary

This trial aims to see if wearing specialized soft contact lenses daily can help slow down nearsightedness in children. It will also study the safety and effectiveness of these lenses. Participants will wear the lenses

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Who is the study for?

This trial is for children with near-sightedness. Participants will wear specialized soft contact lenses daily to see if it slows down their myopia. They must be able to visit the clinic for checkups over a year and keep a diary of when they wear the lenses.Check my eligibility

What is being tested?

The study tests two types of specialized soft contact lenses, worn at different times, to determine their effectiveness in treating childhood myopia progression. Kids will switch between these lenses throughout the day for one year.See study design

What are the potential side effects?

Potential side effects may include visual or ocular discomfort associated with wearing the specialized soft contact lenses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to wear the lenses for at least 10 hours a day, six days a week.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot wear contact lenses due to eye conditions.

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I have a condition affecting my cornea.

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I have crossed eyes with my glasses or contacts on.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in axial length

Change in cycloplegic spherical equivalent refractive error

Secondary study objectives

Change in accommodative response

Change in choroidal thickness

Change in visual acuity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Group AExperimental Treatment1 Intervention

Children who are randomized to this group will wear one type of daily use, daily disposable, single-vision soft contact lens for at least four hours starting in the afternoon (after school) and another type of daily use, daily disposable, single-vision soft contact lens for the remainder of the time daily for one year.

Group II: Control groupPlacebo Group1 Intervention

Children who are randomized to this group will wear daily use, daily disposable, single-vision soft contact lenses full time for one year. Contact lenses will be worn for a minimum of 10 hours per day.

0 / 4Eligibility criteria met