Effect of Eyelid Patching After Ptosis Surgery

NCT ID: NCT05770973

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-01

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ptosis, Eyelid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized for compression dressing or none
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Compression dressing

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

Group Type ACTIVE_COMPARATOR

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 Type OTHER

Compression dressing after ptosis surgery

No Compression dressing

Randomized, eyes were not patched with a dressing.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ptosis

Exclusion Criteria

* kongenital ptosis, pre-surgery, trauma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Augenklinik LMU

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Schuh

Role: PRINCIPAL_INVESTIGATOR

Augenklinik LMU

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Augenklink LMU

München, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-304

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

FACE-Q in Blepharoplasty
NCT04924972 COMPLETED
TPS After Upper Blepharoplasty
NCT02879552 COMPLETED