Hyperopia Treatment Study 1 (HTS1) - Glasses vs Observation

NCT01515475 | Completed Results DMC

• 2 other identifiers: HTS12U10EY011751
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hyperopia

Keywords

Hyperopia; Glasses

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Confirmation of Failure Criteria

  At the 36-month visit, each subject's condition will be classified as either failure or not a failure. 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. The participant met failure criteria if ANY of the following criteria (except strabismus surgery prior to the 3-year outcome exam) were met during testing at the 3-year examination both with and without trial frames (without prism or bifocal), and the criteria was confirmed by a retest 1. Any measurable manifest strabismus in primary gaze at distance or at near not correctable with distance refractive correction alone 2. Strabismus surgery prior to the 36-month exam 3. Distance VA below age norms in either eye 4. ≥2 logMAR lines of IOD if VA is 20/25 or worse in the better-seeing eye 5. ≥3 logMAR lines of IOD if VA is 20/20 or better in the better-seeing eye 6. Stereoacuity measured at near below age normal values

  36 months after randomization

Secondary Outcomes (16)

• Subgroup Analysis - Race

  36 months after randomization

• Subgroup Analysis - Gender

  36 months

• Subgroup Analysis - Family History of Amblyopia

  36 months

• Subgroup Analysis - Family History of Strabismus

  36 months

• Subgroup Analysis - SE Anisometropia

  36 months

Study Arms (2)

Glasses

ACTIVE COMPARATOR

Glasses are prescribed at enrollment and worn per protocol throughout the duration of the study.

Procedure: Glasses

Observation

PLACEBO COMPARATOR

Glasses will not be prescribed unless the patient has confirmation of one or more deterioration criteria as described in the protocol.

Procedure: Glasses

Interventions

Glasses PROCEDURE

Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.

Glasses; Observation

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

Study Sites (2)

The Ohio State University College of Optometry

Columbus, Ohio, 43210-1280, United States

Location

Rocky Mountain Eye Care Associates

Salt Lake City, Utah, 84107, United States

Location

Related Publications (3)

• Pediatric Eye Disease Investigator Group. Clinical factors associated with moderate hyperopia in preschool children with normal stereopsis and visual acuity. J AAPOS. 2016 Oct;20(5):455-457. doi: 10.1016/j.jaapos.2016.04.012. Epub 2016 Sep 20.

  PMID: 27663627 BACKGROUND

• Pediatric Eye Disease Investigator Group; Kulp MT, Holmes JM, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Manny RE, Superstein R, Roberts TL, Avallone JM, Fishman DR, Erzurum SA, Leske DA, Christoff A. A Randomized Clinical Trial of Immediate versus Delayed Glasses for Moderate Hyperopia in 1- and 2-Year-Olds. Ophthalmology. 2019 Jun;126(6):876-887. doi: 10.1016/j.ophtha.2018.12.049. Epub 2019 Jan 4.

  PMID: 30615896 RESULT

• Holmes JM, Kulp MT, Dean TW, Suh DW, Kraker RT, Wallace DK, Petersen DB, Cotter SA, Crouch ER, Lorenzana IJ, Ticho BH, Verderber LC, Weise KK; Pediatric Eye Disease Investigator Group. A Randomized Clinical Trial of Immediate Versus Delayed Glasses for Moderate Hyperopia in Children 3 to 5 Years of Age. Am J Ophthalmol. 2019 Dec;208:145-159. doi: 10.1016/j.ajo.2019.06.021. Epub 2019 Jun 28.

  PMID: 31255587 RESULT

MeSH Terms

Conditions

Hyperopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Results Point of Contact

• Title: Ray Kraker M.S.P.H.
• Organization: Jaeb Center for Health Research

rkraker@jaeb.org

813-975-8690

Study Officials

• Marjean Kulp, OD, MS

  Jaeb Center for Health Research

  STUDY CHAIR

• David Petersen, MD

  Jaeb Center for Health Research

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2012
• First Posted: January 24, 2012
• Study Start: February 23, 2012
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: July 16, 2019
• Results First Posted: May 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available after publication of each primary manuscript.
• Access Criteria: Users accessing the data must enter an email address.

Locations

US (2)