Peripheral Optics in Myopia and Orthokeratology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of the current study is to investigate changes in peripheral refraction and aberration in children wearing orthokeratology lenses and single-vision spectacles.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Myopic Control for High Myopes Using Orthokeratology

NCT00977236

Myopia

COMPLETED NA

Toric Orthokeratology - Slowing Eye Elongation

NCT00978692

Myopia Astigmatism

COMPLETED NA

Retardation of Myopia in Orthokeratology

NCT00962208

Myopia

COMPLETED NA

Peripheral Relative Refractive Power of Orthokeratology Lenses

NCT07294404

Myopia; Refractive Error Myopia

COMPLETED

Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children

NCT06295536

Ametropia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Apart from being effective in reducing low to moderate myopia, orthokeratology has been shown to have potential in retarding myopic progression. The central cornea is flattened and peripheral optics altered in orthokeratology and it has been suggested that orthokeratology slows myopic progression through the alteration of peripheral optics. The aim of the current study is to investigate the changes in peripheral refraction and aberration in children wearing orthokeratology (study group) and single-vision spectacles (control group).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Orthokeratology

Myopic children wearing orthokeratology at night will be the study group

Group Type EXPERIMENTAL

Orthokeratology lenses

Intervention Type DEVICE

Nightly use of orthokeratology lenses to correct the refractive errors

Others

Myopic children wearing single-vision spectacles in the daytime will serve as control group

Group Type OTHER

Spectacles

Intervention Type DEVICE

Daily use of single vision lenses to correct refractive errors

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Orthokeratology lenses

Nightly use of orthokeratology lenses to correct the refractive errors

Intervention Type DEVICE

Spectacles

Daily use of single vision lenses to correct refractive errors

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Menicon Z Night Lens 2 Menicon Z Night Lens 2 Toric Glasses Eyeglasses

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Myopia (refractive sphere): \> 0.50D and ≤ 6.00D
* Astigmatism: with-the-rule astigmatism (axes 180 +/- 30) ≤ 1.50D; astigmatism of other axes ≤ 0.50D
* Spherical equivalent (SE): \> 0.50D and ≤ 6.75D (myopia)
* Best corrected monocular visual acuity: equal to or better than 6/7.5 in Snellen scale
* Willingness to wear contact lenses or spectacles on a daily basis
* Availability for follow-up for at least 2 years

Exclusion Criteria

* Strabismus at distance or near
* Contraindication for contact lens wear and orthokeratology (e.g. limbus to limbus corneal cylinder and dislocated corneal apex)
* Prior experience with the use of rigid lenses (including orthokeratology)
* Prior experience with myopic control treatment (e.g. refractive therapy or progressive spectacles)
* Systemic or ocular conditions which may affect contact lens wear (e.g. allergy and medication)
* Systemic or ocular conditions which may affect refractive development (e.g. Down syndrome, ptosis)

Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes