Myopia Control With Orthokeratology Contact Lenses in Spain

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

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-01

Study Completion Date

2010-03-01

Brief Summary

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

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children.

Related Clinical Trials

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

Eleven Years of Menicon Z Night Contact Lens Wear in Reducing Myopia Progression in Children

NCT04806711

Myopia, Progressive Children, Only

COMPLETED NA

Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia

NCT04806698

Myopia, Progressive Children, Only

COMPLETED NA

Monthly Replacement Orthokeratology for Myopia Control in Young Children

NCT04293328

Myopic Progression

UNKNOWN NA

Toric Orthokeratology - Slowing Eye Elongation

NCT00978692

Myopia Astigmatism

COMPLETED NA

Monthly Replacement Orthokeratology for Myopia Control in Existing Lens Wearers

NCT04295707

Myopic Progression

UNKNOWN NA

Detailed Description

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

The purpose of this prospective study is to assess the efficacy, safety and patient-reported outcomes of the Menicon Z Night orthokeratolgy contact lens for reducing myopia progression in children in comparison with a group of distance, single-vision glasses over a 2-year period. Efficacy was evaluated by assessing differences in the axial length between groups. Safety was evaluated by comparing the incidence of adverse events between groups. Differences between groups in patient-reported outcomes were evaluated using a questionnaire that assessed vision-related quality-of-life measures.

Conditions

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

Myopia, Progressive Children, Only Contact Lens Complication Perception, Self Axial 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

Prospective, controlled, longitudinal

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.

Menicon Z Night

The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years

Group Type EXPERIMENTAL

Menicon Z Night

Intervention Type DEVICE

To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children

Glasses

The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

Distance, single-vision glasses were used as control

Interventions

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

Menicon Z Night

To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children

Intervention Type DEVICE

Control

Distance, single-vision glasses were used as control

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Be 6 to 12 years of age, both ages inclusive
* A low-to-moderate level of myopia (between -0.75 and -4.00 D) and of astigmatism (≤ 1.00 D)
* Neophyte contact lens wearer
* Be successfully fitted with spectacles or orthokeratology contact lenses
* Be able to achieve, through spherical refraction correction, a logMAR visual acuity of 0.8 or better in each eye
* Be willing and able to follow the subject instructions and to meet the protocol-specified schedule of follow-up visits
* White European ethnicity

Exclusion Criteria

* Systemic or ocular disease affecting ocular health
* Use of any systemic or topical medications that could affect ocular physiology or contact lens performance
* Any lid or anterior segment abnormalities for which contact lens wear could be contraindicated
* CCLRU grade ≥ 2 for any given anterior segment ocular clinical signs
* Aphakic, amblyopic, and atopic individuals
* Refractive astigmatism ≥ ½ spherical refraction
* Previous contact lens wear

Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes