NCT06111170

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

October 25, 2023

Last Update Submit

October 30, 2023

Conditions

Dermatochalasis of Eyelid

Outcome Measures

Primary Outcomes (1)

  • Edema

    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)

Study Arms (2)

Compression dressing

ACTIVE COMPARATOR

Compression dressing was applied to one of the eyelids which was chosen by randomization postoperatively

Device: Compression dressing

no dressing

NO INTERVENTION

No dressing was applied on the other eyelid (control group)

Interventions

Compression dressingDEVICE

Application of dressing

Compression dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklink LMU

München, Germany

Location

Related Publications (1)

  • Schuh A, Reischmann L, Hintschich CR. Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain, and Ocular Surface Irritation. Ophthalmic Plast Reconstr Surg. 2024 Nov-Dec 01;40(6):627-633. doi: 10.1097/IOP.0000000000002666. Epub 2024 Apr 11.

    PMID: 38624150DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
There was one blinded observer evaluating the results using pre and postoperative photographs.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two arms. After randomization one eyelid of each patient was applied with a compression dressing, the other eyelid not.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Anna Schuh, Consultant in Oculoplastics, FEBO

Study Record Dates

First Submitted

October 25, 2023

First Posted

November 1, 2023

Study Start

December 1, 2020

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

DE(1)