Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

Completed · Not applicable

Conditions studied: Hyperopia

In brief

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.

Key facts

Study ID

NCT01515475

Run by

Jaeb Center for Health Research

People needed

249

Starts

2012-02-23

Expected to finish

2018-02-01

Last updated by the study team

2019-07-16

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Ohio State University College of Optometry — Columbus, Ohio, United States
• Rocky Mountain Eye Care Associates — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.