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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05528016
• Other study ID #: 09.2022.102
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: September 2022
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brow Ptosis
• Cutis Laxa
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Meibomian Gland Dysfunction
• Ocular Surface Disease

Intervention

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.

Locations

Country	Name	City	State
Turkey	Marmara University Pendik Research and Educational Hospital	Istanbul	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Eyebrow position	Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.	Baseline / 1 Week / 1 Month / 1 Year
Primary	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
Primary	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