NCT05770973

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 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

July 1, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.4 years

First QC Date

February 23, 2023

Last Update Submit

March 4, 2023

Conditions

Ptosis, Eyelid

Keywords

Ptosis, Blepharoplasty, Eyelid surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Compression dressing

ACTIVE COMPARATOR

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

No Compression dressing

NO INTERVENTION

Randomized, eyes were not patched with a dressing.

Interventions

Compression dressing (build by Kompressen, gauze swabs, Nobamed Paul Danz AG, Wetter, Germany and NOBALUMENAL® - steril, eye pad, Nobamed Paul Danz AG, Wetter, GermanyOTHER

Compression dressing after ptosis surgery

Compression dressing

Eligibility Criteria

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

You may qualify if:

  • Ptosis

You may not qualify if:

  • kongenital ptosis, pre-surgery, trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklink LMU

München, Germany

Location

MeSH Terms

Conditions

Blepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Officials

  • Anna Schuh

    Augenklinik LMU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized for compression dressing or none
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 16, 2023

Study Start

July 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Date will be shared on request.

Locations

DE(1)