Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty

September 1, 2022 updated by: Marmara University

Elaborated Analysis of Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position

This study aims to evaluate the short and long-term effects of skin-only and skin+muscle excision blepharoplasty on corneal nerves, dry eye parameters, meibomian glands, and eyebrow position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study was designed with the approval of the Ethics Committee on Human Research of Marmara University and was conducted following the tenets of the Declaration of Helsinki. Written informed consent was obtained from all patients who received information about the procedure and the postoperative course. The study included 48 eyes of 24 patients older than 18 who applied to Marmara University Oculoplastic and Orbital Surgery Unit due to dermatochalasis and were suggested upper eyelid blepharoplasty for medical or cosmetic purposes. The patients were divided into two groups, Group S (n=12) for skin excision only and Group M (n=12) for skin+muscle excision by the decision of the surgeon. In addition to all ophthalmological examinations, sub-basal nerve plexus parameters with corneal confocal microscopy, Schirmer I test, non-invasive tear break-up time, meibomian gland area loss measurements with infrared meibography, central eyebrow height, and lateral eyebrow height were evaluated at baseline and postoperative 1st week, 1st month and 1st-year follow-ups.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Pendik
      • Istanbul, Pendik, Turkey, 34899
        • Marmara University Pendik Research and Educational Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18.
  • Patients with dermatochalasis.
  • Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.

Exclusion Criteria:

  • Patients who have had previous periorbital or ophthalmic surgery
  • Patients with extensive blepharitis
  • History of contact lens use
  • History of ophthalmic, endocrinological, neurological, or rheumatological diseases
  • History of facial paralysis
  • Negative Bell's phenomenon
  • Schirmer test <5mm
  • The patients who had been treated with periocular botulinum toxin in the last 1 year were not included the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Skin-Only Blepharoplasty
Only the skin excision was performed for upper eyelid dermatochalasis.
Procedure: Upper Eyelid Blepharoplasty
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
Active Comparator: Skin+Muscle Blepharoplasty
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
Procedure: Upper Eyelid Blepharoplasty
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal nerve fiber density (CNFD)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNFD in fibers/mm2
Baseline / 1 Week / 1 Month / 1 Year
Corneal nerve branch density (CNBD)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.
Baseline / 1 Week / 1 Month / 1 Year
Corneal nerve fiber length (CNFL)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.
Baseline / 1 Week / 1 Month / 1 Year
Eyebrow position
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Baseline / 1 Week / 1 Month / 1 Year
Meibomian Gland Area Loss (MGAL)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage.
Baseline / 1 Week / 1 Month / 1 Year
Non-invasive Tear Break-Up Time (NI-BUT)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
Phoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate non-invasive tear break-up time in seconds.
Baseline / 1 Week / 1 Month / 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Principal Investigator: Volkan Dericioğlu, M.D, Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 1, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2022.102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data supporting the study findings are available from the corresponding author upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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