Road safety of Stellest lenses compared to conventional single vision lenses in children, adolescents and young adults with myopia

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00037459

Enrollment

140

Registered

2025-12-18

Start date

2026-01-07

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H52.1

Interventions

Group 1: Intervention group: 70 myopia patients aged 8–21 years wearing glasses with Stellest-lenses designed for myopia control 1. Initial examination for spectacle lens fitting and baseline: Refrac

Eligibility

Sex/Gender

All

Age

8 Years to 21 Years

Inclusion criteria

Inclusion criteria: Myopia = -0,25 dpt Astigmatism = 3 dpt

Exclusion criteria

Exclusion criteria: High myopia = - 6.0 dpt Astigmatism > 3 dpt Anisometropia > 2 dpt Amblyopia, nystagmus, manifest strabismus, retinal diseases, developmental retardation

Design outcomes

Primary

Measure	Time frame
The study examines whether Stellest® lenses achieve comparable results to classic single vision lenses in standardised vision tests according to FeV (German Driving Licence Regulations). The primary objective is to map the different groups as detailed as possible with regard to the examinations and to objectively determine whether there are differences in the visual functions relevant to driving ability. To determine this, patients undergo ophthalmological examinations at least one week and no more than three months after their lenses (Stellest or single vision) have been fitted. The examinations and test parameters used are listed below: • Visual acuity (visual acuity) with the best possible correction (Landolt rings) • Visual field test (Goldmann perimeter) • Motility test and stereo vision (Titmus stereo test) • Twilight vision with and without glare (Rodenstock nyctometer) • Colour vision (Ishihara test with 24 colour plates or anomaloscope) • Fundus • Documentation of other abnormalities (e.g. slit lamp examination)	—

Measure

Time frame

The study examines whether Stellest® lenses achieve comparable results to classic single vision lenses in standardised vision tests according to FeV (German Driving Licence Regulations). The primary objective is to map the different groups as detailed as possible with regard to the examinations and to objectively determine whether there are differences in the visual functions relevant to driving ability. To determine this, patients undergo ophthalmological examinations at least one week and no more than three months after their lenses (Stellest or single vision) have been fitted. The examinations and test parameters used are listed below: • Visual acuity (visual acuity) with the best possible correction (Landolt rings) • Visual field test (Goldmann perimeter) • Motility test and stereo vision (Titmus stereo test) • Twilight vision with and without glare (Rodenstock nyctometer) • Colour vision (Ishihara test with 24 colour plates or anomaloscope) • Fundus • Documentation of other abnormalities (e.g. slit lamp examination)

—

Secondary

Measure	Time frame
Comparison of the pass rate (suitable/unsuitable) for the FeV vision test (German Driving Licence Regulations) for the two groups.	—

Countries

Germany

Contacts

Public ContactCornelia Mueller

MVZ Augenzentrum Berliner Ring Würzburg

praxis@augenzentrum-berlinerring.de+4917639068695

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026