Clinical Trial: Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)

Brief Summary: The purpose of this study is to compare visual acuity outcomes and development of strabismus after a 3-year follow-up period in children age 12 to <72 months with moderate hyperopia (spherical equivalent +3.00D to +6.00D) who are prescribed glasses either immediately or only after confirmation of pre-specified deterioration criteria.

Detailed Summary:

Moderate and high hyperopia are associated with the development of strabismus and amblyopia. The primary aims of treatment for asymptomatic moderate and high hyperopia in preschool children are to facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present.

The rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child
Sponsor: Jaeb Center for Health Research

Current Primary Outcome: Proportion of subjects with confirmation of failure criteria [ Time Frame: 36 months after randomization ]

At the 36-month visit, each subject's condition will be classified as either failure or not a failure depending upon the criteria as listed in the protocol. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Best Visual Acuity [ Time Frame: 36 months after randomization ]
    A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test.
  • Development of Strabismus [ Time Frame: 36 months after randomization ]
    A treatment group comparison of the proportion of subjects who develop a measurable heterotropia not correctable with glasses alone at 36 months will be performed using the Fisher's exact test
  • Subgroup Analysis [ Time Frame: 36 months after randomization ]
    Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency.
  • Observation Group Deterioration [ Time Frame: Randomization through 36 months after randomization ]
    Proportion of subjects in the observation group who deteriorated during the course of the study will be evaluated and a 95% confidence interval for the proportion will be calculated.
  • Development of Amblyopia [ Time Frame: 36 months after randomization ]
    A treatment group comparison of the proportion of subjects who develop amblyopia during the course of the study will be performed using the Fisher's exact test.
  • Near Visual Acuity [ Time Frame: 36 months after randomization ]
    A treatment group comparison of the mean near visual acuity at the 36-month outcome exam will be performed using a t-test.


Original Secondary Outcome: Same as current

Information By: Jaeb Center for Health Research

Dates:
Date Received: January 11, 2012
Date Started: February 23, 2012
Date Completion: February 2018
Last Updated: April 11, 2017
Last Verified: April 2017