A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children
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).
• Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
• Refractive error meeting the following by cycloplegic autorefraction:
‣ Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye
⁃ Astigmatism \<2.50D both eyes
⁃ Anisometropia \<1.50D SER
• Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:
‣ VA is age normal in both eyes1,2
⁃ 5-6 years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters
⁃ Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters
• Wearing spectacles by parent report ≥90% of waking hours ≥30 days duration before enrollment. For children who meet all other inclusion criteria but whose single-vision spectacles are broken or lost within the last 90 days, enrollment can proceed as long as the child was wearing their single-vision spectacles ≥90% of waking hours ≥30 days before the spectacles were broken or lost.
• Gestational age ≥ 32 weeks.
• Birth weight \>1500 g.
• Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment).
• Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes.
• Family can return in 2 to 4 weeks for possible randomization.
⁃ Child is willing to refrain from contact lenses for the duration of the study.
⁃ Parent has a phone (or access to a phone) and is willing to be contacted by the clinical site staff.
⁃ Relocation outside of the area of an active PEDIG site within the next 32 months is not anticipated.