Hyperopia Treatment Study 1 (HTS1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Jaeb Center for Health Research
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT01515475
First received: January 11, 2012
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Hyperopia
Procedure: Glasses
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Glasses Versus Observation for Moderate Hyperopia in Young Children (HTS1)

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • Proportion of subjects with confirmation of failure criteria [ Time Frame: 36 months after randomization ] [ Designated as safety issue: Yes ]
    At the 36-month visit, each subject's condition will be classified as either failure or not a failure depending upon the criteria as listed in the protocol. The primary analytic approach will be a treatment group comparison of the proportion meeting failure criteria at 36-months using the Fisher's exact test.


Secondary Outcome Measures:
  • Best Visual Acuity [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    A treatment group comparison of the mean maximum visual acuity per subject at the masked 36-month visit (best visual acuity on any test with and without correction) will be performed using a t-test.

  • Development of Strabismus [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    A treatment group comparison of the proportion of subjects who develop a measurable heterotropia not correctable with glasses alone at 36 months will be performed using the Fisher's exact test

  • Subgroup Analysis [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    Treatment effect in subgroups based on baseline factors will be assessed. Outcome failure status at 36 months will be tabulated by subgroup and reviewed for consistency.

  • Observation Group Deterioration [ Time Frame: Randomization through 36 months after randomization ] [ Designated as safety issue: No ]
    Proportion of subjects in the observation group who deteriorated during the course of the study will be evaluated and a 95% confidence interval for the proportion will be calculated.

  • Development of Amblyopia [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    A treatment group comparison of the proportion of subjects who develop amblyopia during the course of the study will be performed using the Fisher's exact test.

  • Near Visual Acuity [ Time Frame: 36 months after randomization ] [ Designated as safety issue: No ]
    A treatment group comparison of the mean near visual acuity at the 36-month outcome exam will be performed using a t-test.


Estimated Enrollment: 672
Study Start Date: February 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glasses
Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.
Procedure: Glasses
For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.
Placebo Comparator: Observation
Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.
Procedure: Glasses
For patients in the glasses group, glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction. If a subject in the observation group has confirmed deterioration, glasses will be prescribed with amount of correction at investigator discretion.

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 facilitate the development of normal visual acuity and to prevent the development of esotropia and amblyopia. Treatment consists of optical correction, typically using glasses. For children with high hyperopia (>+5.00D) and without strabismus or amblyopia, there is general consensus that a correction should be prescribed. Nevertheless, for children with moderate hyperopia (+3.00D to +5.00D) without strabismus or amblyopia, there is less consensus among pediatric eye care professionals. A survey by Lyons et al found that for a 2-year-old child with hyperopia greater than +3.00D, 65% of optometrists would prescribe glasses compared to 25% of ophthalmologists; for a 4-year old with hyperopia greater than +3.00D, 67% of optometrists would prescribe compared with 42% of ophthalmologists. The American Association for Pediatric Ophthalmology and Strabismus (AAPOS) recommends correcting +4.00D or more in 2 to 7 year olds and the American Academy of Ophthalmology recommends a threshold of +4.50D for correction in 2-to 3-year olds. Unlike ophthalmology, optometry does not provide specific recommendations based on age and level of refractive error. Such variation in practice highlights the lack of rigorously collected scientific evidence for the management of this condition. Across all levels of hyperopia, most ophthalmologists and optometrists usually prescribe less than the full cycloplegic refraction (71% in the Lyons survey) when no strabismus or amblyopia is present.

The rationale for proactively correcting moderate hyperopia in an asymptomatic child is the prevention of esotropia, amblyopia, or asthenopia. The argument against correcting moderate hyperopia in an asymptomatic child is the expense and inconvenience of glasses that might be unnecessary and the potential disruption of emmetropization in infants and toddlers. At present, it remains uncertain whether correction of moderate hyperopia is beneficial in terms of visual acuity outcomes or strabismus development. There is some evidence that using partial correction of hyperopia allows emmetropization to take place.

If refractive correction of moderate hyperopia does not reduce the incidence of amblyopia and/or esotropia compared to no refractive correction, then glasses can be avoided. However, if correcting moderate hyperopia does reduce the development of amblyopia and/or esotropia, then the benefits of preemptive refractive correction will have been identified.

  Eligibility

Ages Eligible for Study:   12 Months to 71 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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. 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
    2. Zero (0) or 1 logMAR line interocular difference (IOD) in uncorrected visual acuity measured without cycloplegia using the ATS-HOTV© visual acuity testing protocol
    3. Age-normal stereoacuity on the Randot Preschool Stereotest (see Table 2 of protocol)
  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.

Exclusion Criteria:

A patient is excluded for any of the following reasons:

  1. Any measurable heterotropia at distance (3 meters) or at near (1/3 meter) by cover/uncover testing. Note that patients with heterophoria are eligible.
  2. Previous documented strabismus (parental report must be confirmed by investigator)
  3. Manifest or latent nystagmus evident clinically
  4. 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.
  5. Previous intraocular, refractive, or extraocular muscle surgery
  6. Previous amblyopia treatment
  7. Previous vergence/accommodative therapy
  8. Parental concerns over learning or development
  9. Ocular co-morbidity that may reduce visual acuity
  10. Symptoms of blur or asthenopia
  11. Developmental delay diagnosed by pediatrician or Individualized Education Program (IEP)
  12. Known neurological anomalies (e.g. cerebral palsy, Down syndrome)
  13. Inability to perform visual acuity ATS-HOTV testing if ≥ 36 months of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515475

Contacts
Contact: Ray Kraker, MSPH 888-387-8686 pedig@jaeb.org
Contact: Chelsea Costa 888-387-8686 pedig@jaeb.org

Locations
United States, Ohio
The Ohio State University College of Optometry Recruiting
Columbus, Ohio, United States, 43210-1280
Contact: Marjean Kulp, OD, MS    614-688-3336    MTkulp@optometry.osu.edu   
Principal Investigator: Marjean Kulp, OD, MS         
United States, Utah
Rocky Mountain Eye Care Associates Recruiting
Salt Lake City, Utah, United States, 84107
Contact: David Petersen, MD    801-264-4450    DPetersen@RMEyecare.com   
Principal Investigator: David Petersen, MD         
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
Study Chair: Marjean Kulp, OD, MS Jaeb Center for Health Research
Study Chair: David Petersen, MD Jaeb Center for Health Research
  More Information

No publications provided

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT01515475     History of Changes
Other Study ID Numbers: HTS1, 2U10EY011751
Study First Received: January 11, 2012
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by Jaeb Center for Health Research:
Hyperopia
Glasses

Additional relevant MeSH terms:
Hyperopia
Refractive Errors
Eye Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014