Effect of Compression Dressing After Upper Eyelid Blepharoplasty on Edema, Ecchymosis, Pain and Ocular Surface Irritation

NCT ID: NCT06111170

Last Updated: 2023-11-01

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dermatochalasis of Eyelid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two arms. After randomization one eyelid of each patient was applied with a compression dressing, the other eyelid not.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
There was one blinded observer evaluating the results using pre and postoperative photographs.

Study Groups

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Compression dressing

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

Group Type ACTIVE_COMPARATOR

Compression dressing

Intervention Type DEVICE

Application of dressing

no dressing

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Compression dressing

Application of dressing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Augenklinik LMU

OTHER

Sponsor Role lead

Responsible Party

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Anna Schuh

Dr. med. Anna Schuh, Consultant in Oculoplastics, FEBO

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Augenklink LMU

München, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38624150 (View on PubMed)

Other Identifiers

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20-305

Identifier Type: -

Identifier Source: org_study_id

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