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Creation and validation of a questionnaire for eyelid surgery

Creation and validation of a questionnaire for eyelid surgery - Questionnaire for eyelid surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00036531
Enrollment
100
Registered
2025-04-01
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

H02.3

Interventions

Group 1: Subjects with upper eyelid dermatochalasis and planned upper eyelid blepharoplasty, with ptosis and planned transcutaneous levator resection or with entropion/ectropion and planned tarsal rei

Sponsors

Klinik für Augenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with dermatochalasis and planned upper eyelid blepharoplasty, with ptosis and planned transcutaneous levator resection or with entropion/ectropion and planned tarsal reinplasty. Sufficient physical and mental ability of the patient to cooperate, good knowledge of German.

Exclusion criteria

Exclusion criteria: - Pre-existing diseases of the eyes or eyelids: Patients with severe ophthalmologic diseases such as glaucoma, retinal diseases, keratoconus or inflammatory diseases (e.g. pronounced blepharitis, keratitis, etc.), which could impair eye function or affect the perception of the results of eyelid surgery, as well as regular application of eye drops that may cause local skin irritation. as well as regular application of eye drops that may cause local skin irritation. - Previous aesthetic or reconstructive surgery on the eyelids: Patients who have had surgical or invasive aesthetic treatments on the eyelids in the past (such as previous blepharoplasty) eyelids (such as previous blepharoplasties, eyelid lifts or periorbital filler treatments), as this could influence the perception and evaluation of the current surgical results. results. Patients with a post-Botox facial condition must not have had Botox injections months prior to study entry. - Mental illness or cognitive impairment: Subjects with known mental disorders (e.g., major depression) or cognitive impairment that could affect their ability to answer the questionnaire completely and objectively, could impair their ability to answer the questionnaire completely and objectively. -Inability to follow up: Patients who are unlikely to be able to attend scheduled post-operative follow-up appointments or complete the questionnaires for the required period of time (e.g. due to geographical distance, lack of communication geographical distance, lack of communication or lack of time). - Insufficient language skills: Participants who do not have a sufficient command of the language in which the questionnaire is written to be able to understand and answer the questions. - Acute or chronic diseases affecting the appearance of the face or eyelids: Conditions such as chronic skin diseases (e.g. eczema, psoriasis, neurodermatitis) in the area of the eyelids or chronic swelling due to systemic diseases (e.g. kidney disease) that could influence the postoperative result. - Allergies or hypersensitivities: Patients with known allergies to the materials used, such as local anesthetics or anesthetics or other medications used that could affect the course of treatment or the postoperative assessment. could influence the course of treatment or postoperative assessment. - Lack of consent to participate in the study: Persons who do not wish to give consent to participate in the study or to the processing of their data. give their consent.

Design outcomes

Primary

MeasureTime frame
Subjective, functional and aesthetic satisfaction with the surgical outcome: The aim of this study is to evaluate and validate a questionnaire developed specifically for eyelid surgery. and validate it. The questionnaire is intended to measure the subjective satisfaction of patients with the surgical the perceived aesthetic improvement, the functional efficacy of the procedure and the effects on quality of life. and the effects on quality of life. As part of the validation, in particular the construct validity, criterion validity, internal consistency internal consistency, test-retest reliability and the sensitivity of the instrument to changes in the changes in the postoperative course. This study should ensure that the questionnaire is a reliable and precise instrument for the clinical and scientific evaluation of of treatment results in eyelid surgery. The questionnaire will be administered to patients at the time of indication, on the day of surgery and after 3 and 6 months postoperatively.

Secondary

MeasureTime frame
Subjective, functional and aesthetic reasons to undergo surgery

Countries

Germany

Contacts

Public ContactJakob Wend

Studienzentrale, Klinik für Augenheilkunde

jakob.wend@unimedizin-ffm.de+4969630183493

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026