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Myopia Control

DG1 Spectacle Lens for Near-sightedness

Gainesville, FL
N/A
Recruiting
Research Sponsored by HOYA Lens Thailand LTD.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age of subject at time of parent (or guardian) consent and subject assent: 7 to 10 years old (inclusive)
Be younger than 18 years old
Must not have
Subjects with a history of intraocular surgery
Subjects with ocular or systemic abnormalities that might be expected to affect visual functions or refractive development
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months

Summary

This trial aims to test the safety and effectiveness of a special DG1 lens for controlling myopia progression in children. They will compare this DG1 lens with regular single-vision spectacles to see if

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Who is the study for?
This trial is for children with near-sightedness (myopia). It's not clear what specific age range or other health conditions might be included or excluded, as the provided information lacks detailed eligibility criteria.Check my eligibility
What is being tested?
The study tests if DG1 spectacle lenses can slow down myopia progression in children compared to standard single vision lenses. Kids will wear these glasses and have their eye growth checked over a period of 36 months, with an additional 12-month follow-up.See study design
What are the potential side effects?
Potential side effects are not specified in the provided information. Generally, wearing glasses does not cause direct side effects but may include discomfort or adjustment period to new prescriptions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 7 and 10 years old.
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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 have had eye surgery in the past.
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I have eye or body conditions that could affect my vision or eye shape.
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I have or had lazy eye.
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I have severe nearsightedness that has caused changes in the back of my eye.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 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
Co-Primary Effectiveness Endpoints: Spherical equivalent refraction and Axial Length
Secondary study objectives
Corrected Visual Acuity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DG1 Spectacle LensExperimental Treatment1 Intervention
Group II: Single Vision Spectacle LensPlacebo Group1 Intervention

Find a Location

Closest Location:EyeCare Professionals of Powell· Powell, OH· 14 miles

Who is running the clinical trial?

HOYA Lens Thailand LTD.Lead Sponsor
3 Previous Clinical Trials
426 Total Patients Enrolled
~160 spots leftby Jan 2030
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