NCT04806763

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration 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
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
11 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 26, 2021

Status Verified

March 1, 2021

Enrollment Period

3 years

First QC Date

March 10, 2021

Last Update Submit

March 23, 2021

Conditions

Myopia, ProgressiveChildren, OnlyContact Lens ComplicationPerception, SelfAxial Myopia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Adverse events

    Two years

  • Patient-reported outcomes

    Two years

Study Arms (2)

Menicon Z Night

EXPERIMENTAL

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

Device: Menicon Z Night

Glasses

ACTIVE COMPARATOR

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

Device: Control

Interventions

Menicon Z NightDEVICE

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

Menicon Z Night
ControlDEVICE

Distance, single-vision glasses were used as control

Glasses

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 (3)

  • 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. Orthokeratology vs. spectacles: adverse events and discontinuations. Optom Vis Sci. 2012 Aug;89(8):1133-9. doi: 10.1097/OPX.0b013e318263c5af.

    PMID: 22773180RESULT

  • Santodomingo-Rubido J, Villa-Collar C, Gilmartin B, Gutierrez-Ortega R. Myopia control with orthokeratology contact lenses in Spain: a comparison of vision-related quality-of-life measures between orthokeratology contact lenses and single-vision spectacles. Eye Contact Lens. 2013 Mar;39(2):153-7. doi: 10.1097/ICL.0b013e31827a0241.

    PMID: 23392299RESULT

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, 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, 2010

Study Completion

March 1, 2010

Last Updated

March 26, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share