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Optical Defocus to Stimulate Eye Elongation in Hyperopia (ODSEEH)

Primary Purpose

Hyperopia, Refractive Error

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simultaneous Vision Bifocal Soft Contact Lenses
Single Vision Soft Contact Lenses
Sponsored by
Aller, Thomas A., OD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring Hyperopia, Refractive Error, Ocular Biometrics, Axial Length, Contact Lenses, Bifocal Contact Lenses

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 5-12
  • Hyperopia > +1.25 each eye (cycloplegic refraction)
  • Ability to wear soft contact lenses

Exclusion Criteria:

  • Amblyopia
  • Strabismus
  • Astigmatism > 1.00 diopters
  • Axial Length > 24.00 mm

Sites / Locations

  • 711 Kains Ave

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bifocal Contact Lenses

Single Vision Soft Contact Lenses

Arm Description

Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.

Subjects will be fitted with single vision soft contact lenses with goal of corrected emmetropia at a distance of 20 feet.

Outcomes

Primary Outcome Measures

Axial length

Secondary Outcome Measures

Refractive Error

Full Information

First Posted
July 30, 2009
Last Updated
January 11, 2021
Sponsor
Aller, Thomas A., OD
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1. Study Identification

Unique Protocol Identification Number
NCT00950924
Brief Title
Optical Defocus to Stimulate Eye Elongation in Hyperopia
Acronym
ODSEEH
Official Title
Use of Multifocal Contact Lenses to Stimulate Axial Elongation in Axial Hyperopia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aller, Thomas A., OD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Axial hyperopia results when the length of the eye is too short for the eye to properly focus distance objects on the retina while the focusing system is relaxed. Emmetropization is the process by which the eye actively adjusts various components of the eye to gradually improve the focus of the eye. Emmetropization frequently involves either an increase or a decrease in the growth of the eye, particularly during infancy and childhood. Numerous animal studies suggest that if an animal is exposed to retinal images located behind the retina either centrally or peripherally, the eye will grow in the direction of the focused image. If an abnormally short eye has resulted in hyperopia, exposing such an eye to retinal images partially located behind the retina might encourage axial elongation, thus reducing the hyperopia.
Detailed Description
Hyperopia or farsightedness may cause distance vision and near vision to be blurred. Depending on the severity of the condition and the age of the patient and the status of the binocular vision system, hyperopia can also cause fatigue, asthenopia, headaches, double vision, and amblyopia. Low to moderate amounts of hyperopia rarely cause much difficulty in the young person, but will eventually cause significant near vision problems as the patient ages. Hyperopia can be caused by the eye being too short (axial hyperopia) or by the cornea being too flat or the crystalline lens being to weak (refractive hyperopia). It has been established by the PI that axial growth can be dramatically lessened in children and adolescents with myopia through the use of bifocal contact lenses prescribed in a particular way (The CONTROL Study). Studies by Earl Smith, O.D., Ph.D. have suggested that multi-zonal contact lenses that provide proper axial focus while manipulating peripheral defocus can either discourage or encourage axial growth to treat myopia or hyperopia respectively. In the present study, simultaneous vision bifocal soft contact lenses will be used to encourage axial growth in hyperopic children and adolescents with axial hyperopia in an effort to reduce hyperopia. Subjects will be randomly assigned to wear either bifocal soft contact lenses or single vision soft lenses. The bifocal contact lenses will be prescribed to provide for clear central vision at both distance and near with the near zone of the contact, thus exposing the retina to hyperopic defocus from the distance zone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia, Refractive Error
Keywords
Hyperopia, Refractive Error, Ocular Biometrics, Axial Length, Contact Lenses, Bifocal Contact Lenses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bifocal Contact Lenses
Arm Type
Experimental
Arm Description
Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.
Arm Title
Single Vision Soft Contact Lenses
Arm Type
Placebo Comparator
Arm Description
Subjects will be fitted with single vision soft contact lenses with goal of corrected emmetropia at a distance of 20 feet.
Intervention Type
Device
Intervention Name(s)
Simultaneous Vision Bifocal Soft Contact Lenses
Intervention Description
Simultaneous Vision Bifocal Soft Contact Lenses will be prescribed such that the distance vision as measured by manifest subjective refraction will be properly corrected by the near vision add power and undercorrected by the distance power.
Intervention Type
Device
Intervention Name(s)
Single Vision Soft Contact Lenses
Intervention Description
Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction.
Primary Outcome Measure Information:
Title
Axial length
Time Frame
One year
Secondary Outcome Measure Information:
Title
Refractive Error
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 5-12 Hyperopia > +1.25 each eye (cycloplegic refraction) Ability to wear soft contact lenses Exclusion Criteria: Amblyopia Strabismus Astigmatism > 1.00 diopters Axial Length > 24.00 mm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas A Aller, O.D.
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
711 Kains Ave
City
San Bruno
State/Province
California
ZIP/Postal Code
94066
Country
United States

12. IPD Sharing Statement

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Optical Defocus to Stimulate Eye Elongation in Hyperopia

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