Validation of Quality-of-Life Questionnaires in Chronic Eye Diseases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038609

Enrollment

150

Registered

2025-12-12

Start date

2025-12-15

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

H20

Interventions

Group 1: Patients with uveitis are asked to complete the VFQ-25 and VFQ-9 quality-of-life questionnaires twice, one week apart. The first assessment takes place on site, and the second is conducted on

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: -Non-infectious anterior, intermediate, posterior uveitis, or panuveitis as the primary diagnosis -Good German language skills (able to communicate confidently with medical staff about personal symptoms and disease course; assessed at the discretion of the study personnel)

Exclusion criteria

Exclusion criteria: -Primary glaucoma and other chronic eye diseases that affect quality of life -Active uveitis (defined as >1+ anterior chamber cells, new vitreous cells, or new uveitis findings on the retina or optic disc)

Design outcomes

Primary

Measure	Time frame
The first primary endpoint is the correlation between the results of the short questionnaire (VFQ-9) and those of the long questionnaire (VFQ-25). The target metric is the correlation coefficient (Pearson correlation) between the total scores of both questionnaires. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. The second primary endpoint is the reliability of the short questionnaire (VFQ-9). The target metric is the value of Cronbach’s alpha, which reflects the internal consistency of the VFQ-9 items. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart.	—

Measure

Time frame

The first primary endpoint is the correlation between the results of the short questionnaire (VFQ-9) and those of the long questionnaire (VFQ-25). The target metric is the correlation coefficient (Pearson correlation) between the total scores of both questionnaires. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. The second primary endpoint is the reliability of the short questionnaire (VFQ-9). The target metric is the value of Cronbach’s alpha, which reflects the internal consistency of the VFQ-9 items. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart.

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Secondary

Measure	Time frame
The first secondary endpoint is how well the short version of the questionnaire (VFQ-9) performs equally across all uveitis subgroups. The uveitis forms investigated are: anterior, intermediate, posterior, panuveitis, and scleritis. The target metrics are the correlation between VFQ-9 and VFQ-25 within each subgroup as well as the descriptive statistics. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. The second secondary endpoint is a high completion rate and high completeness of the digital questionnaire, both when administered in the clinic and in the home environment. The target metric is the actual completion rate and completeness. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. During this process, the questionnaires are examined for completion rate and completeness.	—

Measure

Time frame

The first secondary endpoint is how well the short version of the questionnaire (VFQ-9) performs equally across all uveitis subgroups. The uveitis forms investigated are: anterior, intermediate, posterior, panuveitis, and scleritis. The target metrics are the correlation between VFQ-9 and VFQ-25 within each subgroup as well as the descriptive statistics. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. The second secondary endpoint is a high completion rate and high completeness of the digital questionnaire, both when administered in the clinic and in the home environment. The target metric is the actual completion rate and completeness. This parameter will be assessed after completion of data collection. The data are obtained through two administrations of the VFQ-25 and VFQ-9 questionnaires to the patients, conducted one week apart. During this process, the questionnaires are examined for completion rate and completeness.

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Countries

Germany

Contacts

Public ContactLucy Joanne Kessler

Universitätsklinikum Heidelberg

lucyjoanne.kessler@med.uni-heidelberg.de062215638378

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026