Clinical trial NCT05528016: Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Corneal nerve fiber density (CNFD)
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
measure: Corneal nerve branch density (CNBD)
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
measure: Corneal nerve fiber length (CNFL)
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
measure: Eyebrow position
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
measure: Meibomian Gland Area Loss (MGAL)
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
measure: Non-invasive Tear Break-Up Time (NI-BUT)
timeFrame: Baseline / 1 Week / 1 Month / 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Educational Hospital
state: Pendik
Study officials:
affiliation: Marmara University
name: Volkan Dericioğlu, M.D
role: PRINCIPAL_INVESTIGATOR
References: