Clinical trial NCT04806763: Myopia Control With Orthokeratology Contact Lenses in Spain
Official title: Myopia Control With Orthokeratology Contact Lenses in Spain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia, Progressive
Children, Only
Contact Lens Complication
Perception, Self
Axial Myopia
Lead sponsor: Menicon Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Universidad Europea de Madrid
name: Aston University
name: Clinica novovision
First posted: 2021-03-19
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, controlled, longitudinal
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Axial length
timeFrame: Two years
Secondary outcomes:
measure: Adverse events
timeFrame: Two years
measure: Patient-reported outcomes
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.