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NCT05770973 Clinical Trial

Effect of Eyelid Patching After Ptosis Surgery

Ptosis, Eyelid Clinical Trial

Official title:
The Effect of Eyelid Patching After Anterior Lector Reinsertion and Blepharoplasty on Edema, Hematoma, Scar Formation and Ocular Surface Irritation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05770973
Other study ID # 20-304
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date December 1, 2022

Study information
Verified date March 2023
Source Augenklinik LMU
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this randomized, controlled, observer-blinded study is to compare the effect of compression dressing after ptosis surgery. The main question it aims to answer are: Effect of dressing on edema, hematoma, scar formation, ocular surface irritation and postoperative pain. Patients are randomized after surgery for compression dressing or not. Results are scored by a blinded observer. type of study: clinical trial

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date December 1, 2022
Est. primary completion date December 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ptosis Exclusion Criteria: - kongenital ptosis, pre-surgery, trauma

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany
Compression dressing after ptosis surgery

Locations
Country Name City State
Germany Augenklink LMU München

Sponsors (1)
Lead Sponsor Collaborator
Augenklinik LMU

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary hematoma degree of hematoma postoperatively. Ranked by a blinded observer on a four point rating scale (0=none, 1=mild, 2=moderate, 3=severe) using phtographies of the patients eyes. First postoperative day until 8 weeks after surgery
See also
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