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Comparative Study of Objective and Subjective Refraction and Visual Acuity in Eyes with Epithelial Basement Membrane Dystrophy

Comparative Study of Objective and Subjective Refraction and Visual Acuity in Eyes with Epithelial Basement Membrane Dystrophy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036298
Enrollment
100
Registered
2025-03-21
Start date
2025-03-13
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

H18.5

Interventions

Group 1: 50 patients with typical changes in EBMD (Epithelial Basement Membrane Dystrophy) Group 2: 50 healthy test subjects (control group)

Sponsors

Uniaugenklinik Frankfurt am Main
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Adults over the age of 18 who have characteristic clinical morphological findings of EBMD (e.g. maps, dots, fingerprint, corneal erosions) and associated classic clinical symptoms such as blurred vision, glare, recurrent foreign body sensation or epiphora. For the comparison group, healthy subjects without corneal changes and symptoms are included. All subjects must be able to understand the requirements of the study and give written informed consent before the start of the study.

Exclusion criteria

Exclusion criteria: Eyes with a history of surgery or trauma to the cornea or other cornea-related pathologies cornea or other cornea-related pathologies (such as keratoconus, pterygium, corneal scars, corneal dystrophies or degenerations other than EBMD) are not included in the study. The same applies to eyes in which vision is impaired due to diseases of the lens, retina or optic nerve optic nerve (e.g. age-related macular degeneration, diabetic retinopathy, optic atrophy or advanced clouding of the lens) are severely and irreversibly impaired, are not primarily considered in the study.

Design outcomes

Primary

MeasureTime frame
The refraction determined objectively using the autorefractometer shows no significant difference to the subjectively measured refraction measured subjectively. (primary null hypothesis)

Secondary

MeasureTime frame
The best-corrected visual acuity determined using the objectively measured refraction shows no significant difference to the visual acuity determined using the best-corrected visual acuity measured by subjective refraction (secondary null hypothesis)

Countries

Germany

Contacts

Public ContactIngo Schmack

Uniaugenklinik Frankfurt am Main

augen.studien@unimedizin-ffm.de069 6301 83493

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026