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

NCT05528016 | Completed

• 1 other identifier: 09.2022.102
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatochalasis of Eyelid; Ocular Surface Disease; Meibomian Gland Dysfunction; Dry Eye; Brow Ptosis

Keywords

blepharoplasty; skin; orbicularis oculi; corneal confocal microscopy; meibomian gland; dry eye; eyebrow

Outcome Measures

Primary Outcomes (6)

• Corneal nerve fiber density (CNFD)

  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)

  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)

  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

  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)

  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)

  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

Study Arms (2)

Skin-Only Blepharoplasty

ACTIVE COMPARATOR

Only the skin excision was performed for upper eyelid dermatochalasis.

Procedure: Upper Eyelid Blepharoplasty

Skin+Muscle Blepharoplasty

ACTIVE COMPARATOR

Skin plus muscle excision was performed for upper eyelid dermatochalasis.

Procedure: Upper Eyelid Blepharoplasty

Interventions

Upper Eyelid Blepharoplasty PROCEDURE

Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.

Skin+Muscle Blepharoplasty; Skin-Only Blepharoplasty

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Research and Educational Hospital

Istanbul, Pendik, 34899, Turkey (Türkiye)

Location

Related Publications (1)

• Dericioglu V, San B, Sevik MO, Akkaya Turhan S. Skin-Only Versus Skin-Plus-Orbicularis Resection Blepharoplasty: An Elaborated Analysis of Early- and Long-Term Effects on Corneal Nerves, Meibomian Glands, Dry Eye Parameters, and Eyebrow Position. Ophthalmic Plast Reconstr Surg. 2023 Sep-Oct 01;39(5):479-486. doi: 10.1097/IOP.0000000000002376. Epub 2023 Mar 27.

  PMID: 36972140 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Officials

• Volkan Dericioğlu, M.D

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All evaluations and data collection were performed by a blinded investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 6, 2022
• Study Start: May 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)