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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: Upper Eyelid Blepharoplasty


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Skin-Only Blepharoplasty<br>Only the skin excision was performed for upper eyelid dermatochalasis. | Procedure: Upper Eyelid Blepharoplasty<br>* Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.<br>|
| Active Comparator: Skin+Muscle Blepharoplasty<br>Skin plus muscle excision was performed for upper eyelid dermatochalasis. | Procedure: Upper Eyelid Blepharoplasty<br>* Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blepharoplasty, skin, orbicularis oculi, corneal confocal microscopy, meibomian gland, dry eye, eyebrow