Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 4
- 主要终点
- Number of Participants With Confirmation of Failure Criteria
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Months 至 71 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 to < 72 months
- •Refractive error between +3.00D and +6.00D SE (by cycloplegic refraction) in either eye
- •Astigmatism < 1.50D in both eyes
- •Spherical equivalent anisometropia ≤ +1.50D
- •For children 36 to <72 months of age:
- •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
- •Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
- •Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol)
- •Gestational age >32 weeks
- •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.
- •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.
- •Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff.
- •Relocation outside of area of an active PEDIG site for this study within the next 36 months is not anticipated.
排除标准
- •A patient is excluded for any of the following reasons:
- •Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible.
- •Previous documented strabismus (parental report must be confirmed by investigator)
- •Manifest or latent nystagmus evident clinically
- •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.
- •Previous intraocular, refractive, or extraocular muscle surgery
- •Previous amblyopia treatment
- •Previous vergence/accommodative therapy
- •Parental concerns over learning or development
- •Ocular co-morbidity that may reduce visual acuity
- •Symptoms of blur or asthenopia
- •Developmental delay diagnosed by pediatrician or Individualized Education Program (IEP)
- •Known neurological anomalies (e.g. cerebral palsy, Down syndrome)
- •Inability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age
结局指标
主要结局
Number of Participants With Confirmation of Failure Criteria
时间窗: 36 months after randomization
At the 36-month visit, each subject's condition will be classified as either failure or not a failure. 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. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values
次要结局
- Subgroup Analysis - SE Anisometropia(36 months)
- Best Visual Acuity(36 months after randomization)
- Number of Participants With Strabismus at 3 Years(36 months after randomization)
- Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)(36 months)
- Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)(Enrollment to 3 years)
- Subgroup Analysis - Gender(36 months)
- Subgroup Analysis - Family History of Strabismus(36 months)
- Subgroup Analysis - Race(36 months after randomization)
- Subgroup Analysis - Family History of Amblyopia(36 months)
- Deterioration Criteria Met (Prior to 3 Years)(Enrollment to <36 months)
- Percentage of Participants With Hyperopia Reduction(Enrollment to 3 years)
- Proportion With Amblyopia (at Distance)(36 months after randomization)
- Failure to Meet Age-Normal VA at Distance(36 months)
- Binocular Near Visual Acuity(36 months after randomization)
- Mean Stereoacuity(36 months)
- Failure to Meet Age-Normal Stereoacuity at 3 Years(36 months)