N/A
N=249
Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation
Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT01515475 ↗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
| Outcome | Result | p-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
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.