Optical Defocus to Stimulate Eye Elongation in Hyperopia

NCT ID: NCT00950924

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2022-01-01

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.

Conditions

Hyperopia; Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bifocal Contact Lenses

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.

Group Type: EXPERIMENTAL

Simultaneous Vision Bifocal Soft Contact Lenses

Intervention Type: DEVICE

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.

Single Vision Soft Contact Lenses

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

Group Type: PLACEBO_COMPARATOR

Single Vision Soft Contact Lenses

Intervention Type: DEVICE

Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction.

Interventions

Simultaneous Vision Bifocal Soft Contact Lenses

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

Single Vision Soft Contact Lenses

Single vision soft contact lenses will be prescribed to properly correct the distance vision as measured by manifest subjective refraction.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aller, Thomas A., OD

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas A Aller, O.D.

Role: PRINCIPAL_INVESTIGATOR

Unafilliated

Locations

711 Kains Ave

San Bruno, California, United States

Countries

United States

Other Identifiers

NCT00950924

Identifier Type: -

Identifier Source: org_study_id