Myopia Control Effect of DIMS Spectacle Lenses in Czech Children and Young Adults

NCT05943912 | Active Not Recruiting

• 1 other identifier: SGS23/195/OHK4/3T/17
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Keywords

myopia; axial length; DIMS

Outcome Measures

Primary Outcomes (1)

• Axial length of eye

  biometry (Lenstar 900)

  in 36 moths therapy

Secondary Outcomes (1)

• Objective refraction

  in 36 month therapy

Study Arms (2)

Single Vision Spectacle Lens

Participants who chose to correct myopia with single vision spectacle lenses.

Other: Single Vision Spectacle Lens

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Participants who chose to correct myopia with DIMS spectacle lenses.

Other: Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Interventions

Single Vision Spectacle Lens OTHER

36 months of therapy

Single Vision Spectacle Lens

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens OTHER

36 months of therapy

Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens

Eligibility Criteria

• Age: 6 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Czech Technical University in Prague: lead

Study Sites (1)

Czech Technical University

Prague, Czech Republic, Czechia

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Marketa Zakova, Ph.D.

  Czech Technical University in Prague

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 13, 2023
• Study Start: April 17, 2023
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

CZ (1)