Clinical trial NCT01515475: Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation
Official title: Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Keywords: Hyperopia
Glasses
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Pediatric Eye Disease Investigator Group
name: National Eye Institute (NEI)
First posted: 2012-01-24
Enrollment: 249
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Confirmation of Failure Criteria
timeFrame: 36 months after randomization
Secondary outcomes:
measure: Subgroup Analysis - Race
timeFrame: 36 months after randomization
measure: Subgroup Analysis - Gender
timeFrame: 36 months
measure: Subgroup Analysis - Family History of Amblyopia
timeFrame: 36 months
measure: Subgroup Analysis - Family History of Strabismus
timeFrame: 36 months
measure: Subgroup Analysis - SE Anisometropia
timeFrame: 36 months
measure: Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
timeFrame: 36 months
measure: Deterioration Criteria Met (Prior to 3 Years)
timeFrame: Enrollment to <36 months
measure: Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
timeFrame: Enrollment to 3 years
measure: Percentage of Participants With Hyperopia Reduction
timeFrame: Enrollment to 3 years
measure: Best Visual Acuity
timeFrame: 36 months after randomization
measure: Failure to Meet Age-Normal VA at Distance
timeFrame: 36 months
measure: Proportion With Amblyopia (at Distance)
timeFrame: 36 months after randomization
measure: Binocular Near Visual Acuity
timeFrame: 36 months after randomization
measure: Number of Participants With Strabismus at 3 Years
timeFrame: 36 months after randomization
measure: Mean Stereoacuity
timeFrame: 36 months
measure: Failure to Meet Age-Normal Stereoacuity at 3 Years
timeFrame: 36 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
city: Salt Lake City
country: United States
facility: Rocky Mountain Eye Care Associates
state: Utah
Study officials:
affiliation: Jaeb Center for Health Research
name: Marjean Kulp, OD, MS
role: STUDY_CHAIR
affiliation: Jaeb Center for Health Research
name: David Petersen, MD
role: STUDY_CHAIR
References:
citation: Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20.
citation: Pediatric Eye Disease Investigator Group; Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.
citation: Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28.