Effect of Eyelid Patching After Ptosis Surgery

March 4, 2023 updated by: Augenklinik LMU

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ptosis

Exclusion Criteria:

  • kongenital ptosis, pre-surgery, trauma

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
Randomized, eyes were patched with a compression dressing after surgery.
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
No Intervention: No Compression dressing
Randomized, eyes were not patched with a dressing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hematoma
Time Frame: First postoperative day until 8 weeks after surgery
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

Collaborators and Investigators

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

Sponsor

Augenklinik LMU

Investigators

  • Principal Investigator: Anna Schuh, 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)

July 1, 2020

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 4, 2023

First Posted (Actual)

March 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 4, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-304

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Date will be shared on 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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