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

Not Applicable

Completed

• Conditions: Dry Eye; Brow Ptosis; Ocular Surface Disease; Dermatochalasis of Eyelid; Meibomian Gland Dysfunction
• Interventions: Procedure: Upper Eyelid Blepharoplasty

• Registration Number: NCT05528016
• Lead Sponsor: Marmara University

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.

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 Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-08-01
• Study First Submitted: 2022-08-31
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-01
• Last Update Submitted: 2022-09-01
• Study First Posted: 2022-09-06
• Last Update Posted: 2022-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skin+Muscle Blepharoplasty	Upper Eyelid Blepharoplasty	Skin plus muscle excision was performed for upper eyelid dermatochalasis.
Skin-Only Blepharoplasty	Upper Eyelid Blepharoplasty	Only the skin excision was performed for upper eyelid dermatochalasis.

Primary Outcome Measures

Name	Time	Method
Corneal nerve fiber length (CNFL)	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.
Meibomian Gland Area Loss (MGAL)	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.
Corneal nerve fiber density (CNFD)	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
Corneal nerve branch density (CNBD)	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.
Eyebrow position	Baseline / 1 Week / 1 Month / 1 Year	Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Non-invasive Tear Break-Up Time (NI-BUT)	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.

Trial Locations

Locations (1)

Marmara University Pendik Research and Educational Hospital; 🇹🇷 Istanbul, Pendik, Turkey