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Effect of Eyelid Patching After Ptosis Surgery

Primary Purpose

Ptosis, Eyelid

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany
Sponsored by
Augenklinik LMU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ptosis, Eyelid focused on measuring Ptosis, Blepharoplasty, Eyelid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Ptosis Exclusion Criteria: kongenital ptosis, pre-surgery, trauma

Sites / Locations

  • Augenklink LMU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Compression dressing

No Compression dressing

Arm Description

Randomized, eyes were patched with a compression dressing after surgery.

Randomized, eyes were not patched with a dressing.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 23, 2023
Last Updated
March 4, 2023
Sponsor
Augenklinik LMU
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1. Study Identification

Unique Protocol Identification Number
NCT05770973
Brief Title
Effect of Eyelid Patching After Ptosis Surgery
Official Title
The Effect of Eyelid Patching After Anterior Lector Reinsertion and Blepharoplasty on Edema, Hematoma, Scar Formation and Ocular Surface Irritation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augenklinik LMU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ptosis, Eyelid
Keywords
Ptosis, Blepharoplasty, Eyelid surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized for compression dressing or none
Masking
Investigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compression dressing
Arm Type
Active Comparator
Arm Description
Randomized, eyes were patched with a compression dressing after surgery.
Arm Title
No Compression dressing
Arm Type
No Intervention
Arm Description
Randomized, eyes were not patched with a dressing.
Intervention Type
Other
Intervention Name(s)
Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, Germany
Intervention Description
Compression dressing after ptosis surgery
Primary Outcome Measure Information:
Title
hematoma
Description
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.
Time Frame
First postoperative day until 8 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ptosis Exclusion Criteria: kongenital ptosis, pre-surgery, trauma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Schuh
Organizational Affiliation
Augenklinik LMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Augenklink LMU
City
München
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Date will be shared on request.

Learn more about this trial

Effect of Eyelid Patching After Ptosis Surgery

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