NCT04806711

Brief Summary

To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and contact lenses over an 11-year period.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

11 years

First QC Date

March 10, 2021

Last Update Submit

March 17, 2021

Conditions

Myopia, ProgressiveChildren, Only

Outcome Measures

Primary Outcomes (1)

  • Axial length

    To compare axial length growth of white European myopic children wearing Menicon Z Night orthokeratology contact lenses to a control group of distance, single-vision glasses and soft contact lens wearers. Measurements of axial length 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.

    11 years

Study Arms (2)

Menicon Z Night

EXPERIMENTAL

The experimental arm consist of a group of Menicon Z Night orthokeratology contact lens wearers

Device: Menicon Z Night

Control

ACTIVE COMPARATOR

The active comparator arm consist of a control group of distance, single-vision glasses and contact lens wearers

Device: Control

Interventions

Menicon Z NightDEVICE

Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children

Menicon Z Night
ControlDEVICE

Distance, single-vision glasses were used as a control

Control

Eligibility Criteria

Age6 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsWhite European
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: refractive and biometric changes. Invest Ophthalmol Vis Sci. 2012 Jul 31;53(8):5060-5. doi: 10.1167/iovs.11-8005.

    PMID: 22729437RESULT

  • Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R, Sugimoto K. Long-term Efficacy of Orthokeratology Contact Lens Wear in Controlling the Progression of Childhood Myopia. Curr Eye Res. 2017 May;42(5):713-720. doi: 10.1080/02713683.2016.1221979. Epub 2016 Oct 21.

    PMID: 27767354RESULT

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

MyopiaRefractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, controlled, parallel, longitudinal
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 19, 2021

Study Start

March 1, 2007

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share