麻豆传媒

Early use of prescription eyeglasses by young children with hyperopia failed to show a significant vision benefit after 3 years of follow-up in a randomized trial.

Children assigned to glasses had a failure rate of 21% versus 34% for children who were observed during the follow-up period, which did not achieve statistical significance in the 130-patient study.

Still, almost twice as many patients assigned to observation met criteria for vision deterioration, Marjean T. Kulp, OD, of Ohio State University College of Optometry in Columbus, and coauthors reported in .

"Our estimates of failure, after 3 years of 6-month follow-ups, are inconclusive and consistent with a small to moderate benefit or no benefit of immediate prescription of glasses compared with careful observations, with glasses only if deteriorated," the authors concluded.

"A larger study would be needed to determine a more precise estimate of the treatment effect and whether one management strategy is better than the other," they added. "Regardless of initial treatment approach, the moderate to high proportion of deterioration and subsequent moderate proportion of failure at 3 years indicate the need for eye care professionals to closely follow children aged 1 to 2 years with moderate hyperopia."

The study addressed a common and perplexing problem that pediatric ophthalmologists encounter in clinical practice, said David Epley, MD, who practices at EvergreenHealth in Kirkland, Washington.

"We see these kids all the time," said Epley, a clinical spokesperson for the American Academy of Ophthalmology. "They have this moderate degree of hyperopia, or farsightedness, and no other signs or problems. What do we do with these kids? Is it better give them glasses or is it better to watch them? There are camps on both sides who vigorously debate this issue."

The randomized trial was designed with the goal of answering the question once and for all. "Unfortunately, the results show that there is still some question. There is no stronger or better method for treating these kids."

A strong consensus has emerged about the need for optical correction among children with moderate hyperopia and associated strabismus or amblyopia. In contrast, the need for vision correction is less clear for children with moderate hyperopia without strabismus or amblyopia, the authors noted in their introduction.

The rationale for proactive vision correction in a child with asymptomatic hyperopia is to facilitate normal visual acuity and reading function and potentially prevent esotropia, amblyopia, or asthenopia, they continued. Some pediatric eye care specialists see no harm in delaying use of glasses in the absence of symptoms, including some proponents who have about potential negative effects of optical correction on emmetropization.

In support of a countering viewpoint, some evidence has shown that does not impede emmetropization, which usually is completed by the end of a child's first year of life.

To add high-level prospective data to the discussion, Kulp and colleagues performed a randomized, multicenter clinical trial to compare early use of corrective eyewear with observation in young children with moderate hyperopia and no strabismus or amblyopia. Eligibility criteria included ages 1 to <3 years and moderate hyperopia (+3 to +6 diopters spherical equivalent [D SE]), astigmatism ≤1.5 D in each eye and SE anisometropia ≤1.5 D by cycloplegic refraction, and no manifest strabismus at distance or near.

Children assigned to observation received glasses if they met prespecified criteria for deterioration or distance visual acuity, near stereoacuity below age norms, or developed strabismus. The primary endpoint was the rate of failure in each group after 3 years of follow-up with 6-month assessments. The key secondary endpoint was vision deterioration prior to the 36-month assessment.

Failure was defined as development of manifest strabismus, strabismus surgery before the 36-month outcome exam, distance of visual acuity below age norms in either eye, ≥2 or ≥3 logMAR (minimum angle of resolution) lines of interocular difference (depending on baseline visual acuity), or stereoacuity at near below age norms. The definition of deterioration included the same parameters, minus strabismus surgery with the addition of non-protocol treatment in the absence of deterioration.

Of 130 children enrolled in the trial, 106 completed 3 years of follow-up. The authors reported that 11 of 53 patients assigned to glasses met criteria for failure as did 18 of 53 in the observation group (P=0.14). The analysis of deterioration included all 130 patients and showed 20 (34%) assigned to glasses had deterioration as compared with 36 (62%) in the observation groups.

"The big take-home for me is that a pretty high percentage of these kids go on to have strabismus or amblyopia over time, so it's really important when you identify these children that you continue to follow them closely, because a fair number of them will end up needing treatment," Epley told 麻豆传媒.

Comment