Myopia Control With Orthokeratology Contact Lenses in Spain

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Myopia Control With Orthokeratology Contact Lenses in Spain

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

Intervention / Treatment
-----------------
* Device: Menicon Z Night
* Device: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, controlled, longitudinal
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menicon Z Night<br>The experimental group is allocated to wear Menicon Z Night orthokeratology contact lenses for two years | Device: Menicon Z Night<br>* To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children<br>|
| Active Comparator: Glasses<br>The active comparator includes a group that was allocated to wear distance, single-vision glasses for two years | Device: Control<br>* Distance, single-vision glasses were used as control<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Two years |