Clinical trial NCT05943912: Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
Official title: Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myopia
Keywords: myopia
axial length
DIMS
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: To evaluate the efficacy of Defocus Incorporated Multiple Segment (DIMS) lenses in slowing myopia progression in a young European population of progressing myopes. A prospective, non-randomized, observational 3 - year study will be conducted in 80 progressing myopes aged 6-26 years, with myopia between -0,25D and -8,5D and astigmatism -0,25 and -2,25DC. Participants self-selected wearing DIMS (n=55) or single vision (SV) lenses (n=25). Spherical Equivalent Refraction (SER, cycloplegic autorefraction) and axial length (AL) were measured at baseline. AL will be measured at 3M, 6M and every 6M and SER will be measured every 12M.

Brief summary: The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.

Detailed description: The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes).

Defocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15.

The majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes.

The goals of our study:

* compare the efficacy of DIMS spectacle lenses with SV spectacle lenses at slowing the progression of myopia in the category of Czech children and young adults (effect on axial length and refractive changes)
* monitoring axial length and refractive changes in myopic children and young adults (aged 6-26)
* monitoring adaptation to DIMS lenses in myopes aged 6-26 years monitoring the influence of the environment and individual behavior on the progression of myopia

Eligibility criteria: Inclusion Criteria:

* Progressive myopia
* Myopes aged 6-26 years
* Myopia between -0,25D and -8,5D
* Astigmatism -0,25 and -2,25DC

Exclusion Criteria:

* Ocular pathology
* Amblyopia
* Strabism
* Non-compliance to eye examinations

Primary outcomes:
measure: Axial length of eye
timeFrame: in 36 moths therapy
Secondary outcomes:
measure: Objective refraction
timeFrame: in 36 month therapy
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Czech Technical University
state: Czech Republic
Study officials:
affiliation: Czech Technical University in Prague
name: Marketa Zakova, Ph.D.
role: STUDY_DIRECTOR
References: