Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation

October 30, 2023 updated by: Anna Schuh, Augenklinik LMU
Study to analyze whether there is a difference in postoperative outcome regarding edema, ecchymosis, pain, OSI and discomfort of the patients after blepharoplasty if a compression dressing is used or not.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany
        • Augenklink LMU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with upper eyelid dermatochalasis who were scheduled for upper eyelid blepharoplasty

Exclusion Criteria:

  • previous surgery on the upper eyelid, previous eye lid trauma, congenital lid changes, blepharochalasis syndrome, coagulation disorders or indication for combined ptosis and blepharoplasty surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Compression dressing
Compression dressing was applied to one of the eyelids which was chosen by randomization postoperatively
Device: Compression dressing
Application of dressing
No Intervention: no dressing
No dressing was applied on the other eyelid (control group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edema
Time Frame: Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)
Degree of edema postoperatively, rated on a four point rating scale: 0 = no, 1 = minimal, 2 = moderate, 3 = severe
Measures are taken the first day after surgery (D1), one week after surgery (D7) and eight weeks after surgery (D56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Augenklinik LMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 1, 2023

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data that support the findings of this study are available from the corresponding author, [A.S.], upon reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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