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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05528016
Enrollment
24
Registered
2022-09-06
Start date
2021-05-01
Completion date
2022-08-01
Last updated
2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

All evaluations and data collection were performed by a blinded investigator.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Corneal nerve fiber density (CNFD)Baseline / 1 Week / 1 Month / 1 YearAutomated 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 YearAutomated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.
Corneal nerve fiber length (CNFL)Baseline / 1 Week / 1 Month / 1 YearAutomated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.
Eyebrow positionBaseline / 1 Week / 1 Month / 1 YearMillimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Meibomian Gland Area Loss (MGAL)Baseline / 1 Week / 1 Month / 1 YearPhoenix-Meibography Imaging software that is available in the Sirius® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage.
Non-invasive Tear Break-Up Time (NI-BUT)Baseline / 1 Week / 1 Month / 1 YearPhoenix-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026