Myopia Control With Orthokeratology Contact Lenses in Spain

Menicon Co., Ltd.69 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

Menicon Z NightDEVICE

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

ControlDEVICE

Distance, single-vision glasses were used as control

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Axial length

To compare axial length growth between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Measurements of axial length (in millimeters) were taken with the Zeiss IOLMaster (Carl Zeiss Jena GmbH, Jena, Germany). Three separate measurements of axial length were recorded per subject and per visit, and a mean obtained.

Time frame: Two years

Secondary Outcomes

Adverse events

To compare the incidence of adverse events between white children with myopia wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. Adverse events were classified into serious, significant, or non-significant. Recurrences of the same adverse event(s) in the same or fellow eye at any of the subsequent study visits were classified as separate events; bilateral events will be counted as two separate events. The incidence of adverse events was calculated as a percentage of eyes per annum.

Time frame: Two years

Patient-reported outcomes

To compare vision-related quality-of-life measures between children wearing Menicon Z Night orthokeratology contact lenses and distance single-vision glasses. The pediatric refractive error profile survey was used to compare patient-reported outcomes in terms of the vision-specific quality of life between children in the Menicon Z Night and control groups. The survey consists of 26 statements scored from 1 (poor quality of life) to 5 (good quality of life), then scaled from 0 to 100 by subtracting 1 from the raw score of each question and multiplying by 25. The mean score of all items was calculated as the overall score. The survey includes 11 scales: overall vision, near vision, far distance vision, symptoms, appearance, satisfaction, activities, academics, handling, peer perception, and overall score.

Time frame: Two years

Data from ClinicalTrials.gov

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