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Enhancement of Emmetropization in Highly Hyperopic Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03669146
Recruitment Status : Recruiting
First Posted : September 13, 2018
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
Donald O Mutti, OD, PhD, Ohio State University

Tracking Information
First Submitted Date  ICMJE September 11, 2018
First Posted Date  ICMJE September 13, 2018
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE April 24, 2019
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
Central cycloplegic refractive error with retinoscopy [ Time Frame: 18 months ]
The subject's central refractive error will be measured (in Diopters) with cycloplegic retinoscopy to determine if partial refractive correction and accommodative training can enhance emmetropization in highly hyperopic infants. Successful enhancement is defined as being an average of 1.75 Diopters less hyperopic than control subjects at 18 months.
Original Primary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
Central cycloplegic refractive error with SureSight autorefractor [ Time Frame: 18 months ]
The subject's central refractive error will be measured (in Diopters) with a SureSight autorefractor to determine if partial refractive correction and accommodative training can enhance emmetropization in highly hyperopic infants. Successful enhancement is defined as being an average of 1.75 Diopters less hyperopic than control subjects at 18 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2019)
  • Peripheral cycloplegic refractive error with SureSight autorefractor [ Time Frame: 18 months ]
    The subject's central and peripheral refractive error will be measured (in Diopters) with the SureSight autorefractor to determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of ocular shape in highly hyperopic infants.
  • Accommodative response with PowerRefractor [ Time Frame: 18 months ]
    The subject's accommodative ability will be measured objectively with a PowerRefractor autorefractor to determine determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of accommodation in highly hyperopic infants.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2018)
  • Peripheral cycloplegic refractive error with SureSight autorefractor [ Time Frame: 18 months ]
    The subject's peripheral refractive error will be measured (in Diopters) with a SureSight autorefractor to determine if partial refractive correction and accommodative training can enhance emmetropization through modulation in ocular shape in highly hyperopic infants.
  • Accommodative response with PowerRefractor [ Time Frame: 18 months ]
    The subject's accommodative ability will be measured objectively with a PowerRefractor autorefractor to determine determine if partial refractive correction and accommodative training can enhance emmetropization through modulation of accommodation in highly hyperopic infants.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancement of Emmetropization in Highly Hyperopic Infants
Official Title  ICMJE The Enhancement Via Accommodation (EVA) Study
Brief Summary

Infants do not usually wear glasses because they usually do not need them to see clearly. Most infants are born with a moderate amount of farsightedness. Most infants then undergo a natural process called 'emmetropization' that reduces the amount of farsightedness. However, up to 10% of infants don't emmetropize and end up with very farsighted prescriptions. Farsighted infants must use extra focusing effort to see clearly, which may make their eyes cross and perhaps cause a "lazy eye". If infants avoid this effort and their vision stays blurred into childhood, they may develop two lazy eyes. Farsightedness in school-aged children makes reading and learning more difficult. New studies in animals and in humans show that infant eyes will emmetropize best if they have just a normal, moderate amount of farsightedness. The infant eye must be in this normal target zone in order to emmetropize. If a baby were given glasses with the full prescription to correct all of his farsightedness, the eyes would also be out of the target zone and would not receive any signal to grow. The best strategy might be to give a partial spectacle correction for the farsightedness, just enough to put them in the zone that is most effective for emmetropization.

The purpose of this project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction and accommodative (eye focusing) training. The partial correction is an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. As changes in farsightedness occur, the power of the glasses will be reduced to keep the farsightedness within the target zone. If an infant reaches a normal amount of farsightedness, the glasses will be discontinued. The comparison group will be farsighted babies who receive the current standard of care, namely no correction. The main outcome of the study will be whether there is a significant difference in the decrease of farsightedness between the two groups when the infants are 18 months of age.

If emmetropization can be enhanced in very farsighted babies, the risk of developing crossed or lazy eye will be reduced. The lifelong need for spectacles, contact lenses, or refractive surgery for high amounts of farsightedness would also be reduced. Positive results might also make infant eye examinations more common and place a new therapeutic option in clinicians' hands.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description:
A provider other than the investigator(s) will be masked to the primary outcome of the study.
Primary Purpose: Treatment
Condition  ICMJE Hyperopia
Intervention  ICMJE Device: Glasses
Partial refractive correction in a pair of glasses.
Study Arms  ICMJE
  • Experimental: Hyperopic subjects receiving glasses
    Randomized +5.00 to +7.00 diopter hyperopic subjects that will receive partial refractive correction and will be instructed to do accommodation exercises on a daily basis.
    Intervention: Device: Glasses
  • No Intervention: Hyperopic subjects uncorrected
    Randomized +5.00 to +7.00 diopter hyperopic subjects that will serve as the control to the experimental arm who will receive no correction but be observed for the duration of the study.
  • Active Comparator: Highly hyperopic subjects corrected
    If a subject is found to be greater than +7.00 diopters hyperopic during the screening phase of the study, they will receive glasses correction and be followed during the study period.
    Intervention: Device: Glasses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age: between 8 and 15 weeks at baseline examination
  • Either gender
  • Any ethnicity
  • Birthweight greater than 2500g
  • Normal pregnancy and delivery (including Cesarean section delivery but excluding serious complications or conditions such as eclampsia or rubella)
  • Hyperopia greater than or equal to +5.00 Diopters (D) in the spherical component of refractive error in one or both eyes measured with cycloplegic retinoscopy using 1% cyclopentolate
  • Infants with a refractive error of greater than or equal to +5.00D but less than or equal to +7.00D in the spherical component of refractive error will be randomized to treatment (partial correction with accommodative training) or observation only.
  • Infants with greater than +7.00D in the spherical component of refractive error will receive treatment

Exclusion Criteria:

  • Astigmatism greater than 2.00D in either eye
  • Anisometropia greater than 1.50D (spherical equivalent)
  • History of strabismus surgery
  • History of difficulty with pupillary dilation
  • History of cardiac, liver, asthma, or other respiratory disease
  • History of ocular disease, retinal detachment, severe macular dragging, intraocular surgery, optic nerve hypoplasia, malformations of the eye, cortical visual impairment or active inflammation
  • History of hydrocephalus, Down syndrome, cerebral palsy, developmental delay, seizure disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Weeks to 15 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ann M Morrison, OD, MS 614-247-0010 morrison.421@osu.edu
Contact: Donald O Mutti, OD, PhD 614-247-7057 mutti.2@osu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03669146
Other Study ID Numbers  ICMJE NEW-33235
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Donald O Mutti, OD, PhD, Ohio State University
Study Sponsor  ICMJE Donald O Mutti, OD, PhD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Donald O Mutti, OD, PhD Ohio State University
Study Chair: Ann M Morrison, OD, MS Ohio State University
PRS Account Ohio State University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP