HTS1

Overview

About this study

Some doctors feel that a child with hyperopia (farsightedness) should have glasses before any potential vision problems (such as amblyopia or strabismus) develop. Other doctors feel that children should not be given glasses unless vision problems occur. It is not known if hyperopia should be treated immediately or only if other problems occur. This is the reason this randomized clinical trial is being done.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

  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. Normal visual acuity for age - Uncorrected monocular visual acuity in both eyes using the ATS-HOTV© visual acuity testing protocol without cycloplegia (see section 3.3.3, Table 1)
    2. No amblyopia - Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity without cycloplegia using the ATS-HOTV© visual acuity testing protocol
    3. Normal near stereoacuity for age using the Randot Preschool Stereoacuity test (see section 3.3.3, Table 2)
  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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Erick Bothun, M.D.

Closed for enrollment

More information

Publications

  • A total of 117 children 3-5 years of age with moderate hyperopia in at least one eye, age-normal unaided visual acuity, age-normal stereoacuity, no significant anisometropia or astigmatism, and no strabismus were enrolled in a 3-year randomized clinical trial to compare visual outcomes and ocular alignment in children assigned to immediate glasses or to observation and glasses if deterioration of visual acuity, stereoacuity, or alignment occurred. Pearson correlation coefficients were calculated to evaluate relationships among baseline characteristics. We found a moderate association between higher amounts of uncorrected hyperopia and greater accommodative lag (n = 57; R = 0.31; 95% CI, 0.05-0.53). Higher amounts of hyperopia were weakly associated with worse uncorrected distance visual acuity (n = 117; R = 0.24; 95% CI, 0.06-0.41), and better stereoacuity was weakly associated with better uncorrected near acuity (n = 99; R = 0.24; 95% CI, 0.04-0.42). Read More on PubMed

Additional contact information

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