A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control

Conditions

• Myopia

Eligibility Criteria

Sex

ALL

Age

5 Years - 11 Years

Healthy Volunteers

Not accepted

Interventions

• Atropine — DRUG
  Daily 0.05% atropine eyedrops
• Spectacles with HAL — DEVICE
  Spectacle lenses with highly aspherical lenslets (HAL)
• Placebo Eyedrops — DRUG
  Daily placebo eyedrops

Study Details

To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth. After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to \<12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively. All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months). The study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.\* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.

Key Dates

First listed

Jul 31, 2025

Start date

Jun 1, 2026

Status verified

Jun 2026

Primary completion

Dec 1, 2028

Completion

Jun 1, 2029

Study Design

Enrollment

348 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Atropine Group
  Daily low-concentration atropine (0.05%) eyedrops plus spectacles with single vision lenses (SVL)
• Placebo Comparator: Placebo Group
  Daily placebo eyedrops plus spectacles with single-vision lenses (SVL)
• Experimental: HAL Group
  Daily placebo eyedrops plus spectacles with highly aspherical lenslets
• Experimental: Combined Group
  Daily low-concentration atropine (0.05%) eyedrops plus spectacles with highly aspherical lenslets

Primary Outcome Measure

Primary efficacy outcome - change in axial length [ Time Frame: 24 months. ]

Central Contacts

• Raymond T Kraker, MSPH
  813-975-8690
  [email protected]
• Courtney L Conner
  813-975-8690
  [email protected]

Locations (17)

Find similar trials in Birmingham, AL

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