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N/A N=249 Randomized Single-blind Treatment

Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

Hyperopia

Enrolled (actual)
249
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Confirmation of Failure Criteria — 5; 4; 11; 18 Participants — p=0.72

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Glasses (Procedure)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Jaeb Center for Health Research
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Confirmation of Failure Criteria
5; 4; 11; 18 0.72
SECONDARY
Subgroup Analysis - Race
2; 1; 0; 4; 3; 3
SECONDARY
Subgroup Analysis - Gender
4; 3; 4; 10; 1; 1
SECONDARY
Subgroup Analysis - Family History of Amblyopia
3; 0; 4; 6; 2; 4
SECONDARY
Subgroup Analysis - Family History of Strabismus
3; 0; 5; 7; 2; 4
SECONDARY
Subgroup Analysis - SE Anisometropia
3; 4; 8; 14; 2; 0
SECONDARY
Subgroup Analysis - Mean Refractive Error at Enrollment (Diopters)
3; 2; 2; 6; 1; 1
SECONDARY
Deterioration Criteria Met (Prior to 3 Years)
16; 14; 20; 36
SECONDARY
Mean Change in Spherical Equivalent (SE) Refractive Error (Diopters)
-0.07; -0.67; 0.15; -0.01; 0; -0.58 0.002 sig
SECONDARY
Percentage of Participants With Hyperopia Reduction
17; 42; 20; 37 0.013 sig
SECONDARY
Best Visual Acuity
-0.06; -0.07; 0.06; 0.12; -0.03; -0.01 0.22
SECONDARY
Failure to Meet Age-Normal VA at Distance
0; 1; 3; 4 0.51
SECONDARY
Proportion With Amblyopia (at Distance)
0; 1; 7; 9 0.51
SECONDARY
Binocular Near Visual Acuity
0.01; 0.04; 0.09; 0.12 0.21
SECONDARY
Number of Participants With Strabismus at 3 Years
0; 1; 5; 5 0.51
SECONDARY
Mean Stereoacuity
1.76; 1.75; 2.2; 2.3 0.74
SECONDARY
Failure to Meet Age-Normal Stereoacuity at 3 Years
5; 3; 6; 16 0.53

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.

Eligibility Criteria

Inclusion Criteria

  • Age 12 to 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 Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01515475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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