Overview

This trial is active, not recruiting.

Condition hyperopia
Treatment glasses
Phase phase 3
Sponsor Jaeb Center for Health Research
Collaborator Pediatric Eye Disease Investigator Group
Start date February 2012
End date February 2018
Trial size 672 participants
Trial identifier NCT01515475, 2U10EY011751, HTS1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.
glasses
For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
(Placebo Comparator)
Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.
glasses
For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.

Primary Outcomes

Measure
Proportion of subjects with confirmation of failure criteria
time frame: 36 months after randomization

Secondary Outcomes

Measure
Best Visual Acuity
time frame: 36 months after randomization
Development of Strabismus
time frame: 36 months after randomization
Subgroup Analysis
time frame: 36 months after randomization
Observation Group Deterioration
time frame: Randomization through 36 months after randomization
Development of Amblyopia
time frame: 36 months after randomization
Near Visual Acuity
time frame: 36 months after randomization

Eligibility Criteria

Male or female participants from 12 months up to 71 months old.

Inclusion Criteria: 1. Age 12 to < 72 months 2. Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye 3. Astigmatism < 1.50D in both eyes 4. Spherical equivalent anisometropia ≤ +1.50D 5. For children 36 to <72 months of age: 1. No evidence of subnormal visual acuity - Uncorrected monocular visual acuity in both eyes of 20/50 or better for age 36 to <48 months,20/40 or better for age 48 to <60 months, and 20/32 or better for ages 60 to <72 months measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol 2. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol 3. Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol) 6. Gestational age >32 weeks 7. Investigator is willing to prescribe glasses per protocol or observe the hyperopia untreated for 3 years unless specific criteria for deterioration outlined in section 3.3.3 are confirmed. 8. Parent understands the protocol and is willing to accept randomization to either glasses or no glasses initially, and is willing to wear glasses as prescribed or accept that glasses will not be prescribed by the investigator unless specific deterioration criteria outlined in section 3.3.3 are confirmed. 9. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff. 10. Relocation outside of area of an active PEDIG site for this study within the next 36 months is not anticipated. Exclusion Criteria: A patient is excluded for any of the following reasons: 1. Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible. 2. Previous documented strabismus (parental report must be confirmed by investigator) 3. Manifest or latent nystagmus evident clinically 4. Previous treatment of refractive error with glasses or contacts unless duration of glasses or contacts wear was one week or less and occurred more than 2 months prior to enrollment. 5. Previous intraocular, refractive, or extraocular muscle surgery 6. Previous amblyopia treatment 7. Previous vergence/accommodative therapy 8. Parental concerns over learning or development 9. Ocular co-morbidity that may reduce visual acuity 10. Symptoms of blur or asthenopia 11. Developmental delay diagnosed by pediatrician or Individualized Education Program (IEP) 12. Known neurological anomalies (e.g. cerebral palsy, Down syndrome) 13. Inability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age

Additional Information

Official title Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
Description 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 is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place. If refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Jaeb Center for Health Research.