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Enhancement of Emmetropization in Hyperopic Infants

This study has been terminated.
(Lack of funding support for continued recruitment, enrollment, treatment)
Sponsor:
Collaborator:
The Ohio Lions Eye Research Foundation
Information provided by (Responsible Party):
Donald Mutti, Ohio State University
ClinicalTrials.gov Identifier:
NCT00574717
First received: December 11, 2007
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

To determine if wearing a moderate spectacle under-correction (3.00D) and performing activities designed to stimulate accurate accommodation during a 15-month period will enhance emmetropization in highly hyperopic (between +5.00D and +7.00D) 3-month old infants.


Condition Intervention Phase
Hyperopia
Hypermetropia
Farsightedness
Procedure: Spectacles
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancement of Emmetropization in Hyperopic Infants

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • The primary outcome will be to determine if the criterion level for emmetropization (≤+3.00D by 18 months of age) is met and maintained by at least 70% of treated infants. [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: December 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Infants will receive spectacle under-correction of their hyperopia.
Procedure: Spectacles
Infants will receive spectacles with 3.00D of under-correction relative to the spherical equivalent in each eye as measured by the cycloplegic retinoscopy performed at baseline. They will also receive the full amount of measured astigmatism in their glasses. Changes in spectacle lens power will be made as needed at follow-up visits to keep the level of under-correction within 0.50D of the target 3.00D. A program of visual engagement is also provided to encourage the normal development and use of accommodation. Treatment will continue for 15 months (until 18 months of age) or until the infant reaches a spherical equivalent refractive error of +3.00D or less hyperopia.
Other Name: Under-correction

Detailed Description:

The purpose of the project is to determine if emmetropization can be enhanced in very farsighted babies. We will give them glasses with a partial correction, an amount that is less than their full degree of farsightedness but enough to put them in the zone of effective emmetropization. This 'boost' is meant to enable very farsighted babies to use their eyes in a normal way and emmetropize as normal infants. This partial correction would be given at 3 months of age for a period of up to 15 months. A program of visual engagement is also provided in order to encourage the normal development and use of accommodation. As changes in farsightedness occur, the power of the glasses will be reduced at follow up appointments to keep the farsightedness within the zone of effective emmetropization. Once an infant reaches a normal amount of farsightedness, the glasses would be discontinued.

  Eligibility

Ages Eligible for Study:   8 Weeks to 20 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 3 months of age (between 8 weeks and 20 weeks)at the 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 of +5.00D or more but less than +7.00D spherical equivalent refractive error in each eye by cycloplegic retinoscopy using cyclopentolate 1%
  • Currently under the care of a pediatrician

Exclusion Criteria:

  • Anisometropia greater than 1.00D (difference in spherical equivalent)
  • Strabismus
  • Previous history of difficulty with pupillary dilation
  • History of cardiac, liver, asthma, or other respiratory disease
  • History of ocular disease or active ocular inflammation
  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: NCT00574717

Locations
United States, Ohio
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1240
Sponsors and Collaborators
Ohio State University
The Ohio Lions Eye Research Foundation
Investigators
Principal Investigator: Donald O. Mutti, OD, PhD The Ohio State University College of Optometry
  More Information

Additional Information:
Publications:
Responsible Party: Donald Mutti, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00574717     History of Changes
Other Study ID Numbers: 2004H0157
Study First Received: December 11, 2007
Last Updated: October 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
hyperopia
ocular refraction
infant
vision

Additional relevant MeSH terms:
Hyperopia
Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on November 27, 2014