Status:
COMPLETED
Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Conditions:
Hyperopia
Eligibility:
All Genders
12-71 years
Phase:
NA
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 equiva...
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 fac...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 23 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT01515475
Start Date
February 23 2012
End Date
February 1 2018
Last Update
July 16 2019
Active Locations (2)
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1
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1280
2
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States, 84107