Enhancement of Emmetropization in Hyperopic Infants

NCT00574717 | Terminated Phase 1

• 1 other identifier: 2004H0157
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperopia; Hypermetropia; Farsightedness

Keywords

hyperopia; ocular refraction; infant; vision

Outcome Measures

Primary Outcomes (1)

• 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.

  15 months

Study Arms (1)

A

EXPERIMENTAL

Infants will receive spectacle under-correction of their hyperopia.

Procedure: Spectacles

Interventions

Spectacles PROCEDURE

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.

Also known as: Under-correction

A

Eligibility Criteria

• Age: 8 Weeks - 20 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• The Ohio Lions Eye Research Foundation: collaborator

Study Sites (1)

The Ohio State University College of Optometry

Columbus, Ohio, 43210-1240, United States

Location

Related Publications (8)

• Atkinson J, Anker S, Bobier W, Braddick O, Durden K, Nardini M, Watson P. Normal emmetropization in infants with spectacle correction for hyperopia. Invest Ophthalmol Vis Sci. 2000 Nov;41(12):3726-31.

  PMID: 11053269 BACKGROUND

• Ingram RM, Gill LE, Lambert TW. Effect of spectacles on changes of spherical hypermetropia in infants who did, and did not, have strabismus. Br J Ophthalmol. 2000 Mar;84(3):324-6. doi: 10.1136/bjo.84.3.324.

  PMID: 10684846 BACKGROUND

• Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Axial growth and changes in lenticular and corneal power during emmetropization in infants. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3074-80. doi: 10.1167/iovs.04-1040.

  PMID: 16123404 BACKGROUND

• Mutti DO, Mitchell GL, Jones LA, Friedman NE, Frane SL, Lin WK, Moeschberger ML, Zadnik K. Refractive astigmatism and the toricity of ocular components in human infants. Optom Vis Sci. 2004 Oct;81(10):753-61. doi: 10.1097/00006324-200410000-00007.

  PMID: 15557849 BACKGROUND

• Anker S, Atkinson J, Braddick O, Nardini M, Ehrlich D. Non-cycloplegic refractive screening can identify infants whose visual outcome at 4 years is improved by spectacle correction. Strabismus. 2004 Dec;12(4):227-45. doi: 10.1080/09273970490517935.

  PMID: 15545141 BACKGROUND

• Hung LF, Crawford ML, Smith EL. Spectacle lenses alter eye growth and the refractive status of young monkeys. Nat Med. 1995 Aug;1(8):761-5. doi: 10.1038/nm0895-761.

  PMID: 7585177 BACKGROUND

• Schaeffel F, Glasser A, Howland HC. Accommodation, refractive error and eye growth in chickens. Vision Res. 1988;28(5):639-57. doi: 10.1016/0042-6989(88)90113-7.

  PMID: 3195068 BACKGROUND

• Smith EL 3rd, Hung LF. The role of optical defocus in regulating refractive development in infant monkeys. Vision Res. 1999 Apr;39(8):1415-35. doi: 10.1016/s0042-6989(98)00229-6.

  PMID: 10343811 BACKGROUND

Related Links

• College of Optometry Website
• Principal Investigator Web Page

MeSH Terms

Conditions

Hyperopia

Interventions

Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Donald O. Mutti, OD, PhD

  The Ohio State University College of Optometry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 17, 2007
• Study Start: December 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 19, 2012

Record last verified: 2012-10

Locations

US (1)