Optical Defocus to Stimulate Eye Elongation in Hyperopia

NCT00950924 | Unknown DMC

• 1 other identifier: NCT00950924
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperopia; Refractive Error

Keywords

Hyperopia; Refractive Error; Ocular Biometrics; Axial Length; Contact Lenses; Bifocal Contact Lenses

Outcome Measures

Primary Outcomes (1)

• Axial length

  One year

Secondary Outcomes (1)

• Refractive Error

  One year

Study Arms (2)

Bifocal Contact Lenses

EXPERIMENTAL

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.

Device: Simultaneous Vision Bifocal Soft Contact Lenses

Single Vision Soft Contact Lenses

PLACEBO COMPARATOR

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

Device: Single Vision Soft Contact Lenses

Interventions

Simultaneous Vision Bifocal Soft Contact Lenses 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.

Bifocal Contact Lenses

Single Vision Soft Contact Lenses DEVICE

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

Single Vision Soft Contact Lenses

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aller, Thomas A., OD: lead

Study Sites (1)

711 Kains Ave

San Bruno, California, 94066, United States

Location

MeSH Terms

Conditions

Hyperopia; Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Thomas A Aller, O.D.

  Unafilliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2009
• First Posted: August 3, 2009
• Study Start: January 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

US (1)