Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
Primary Purpose
Dermatochalasis of Eyelid, Ocular Surface Disease, Meibomian Gland Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Upper Eyelid Blepharoplasty
Sponsored by
About this trial
This is an interventional prevention trial for Dermatochalasis of Eyelid focused on measuring blepharoplasty, skin, orbicularis oculi, corneal confocal microscopy, meibomian gland, dry eye, eyebrow
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.
Sites / Locations
- Marmara University Pendik Research and Educational Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Skin-Only Blepharoplasty
Skin+Muscle Blepharoplasty
Arm Description
Only the skin excision was performed for upper eyelid dermatochalasis.
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
Outcomes
Primary Outcome Measures
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
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.
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.
Eyebrow position
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05528016
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
All evaluations and data collection were performed by a blinded investigator.
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin-Only Blepharoplasty
Arm Type
Active Comparator
Arm Description
Only the skin excision was performed for upper eyelid dermatochalasis.
Arm Title
Skin+Muscle Blepharoplasty
Arm Type
Active Comparator
Arm Description
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
Intervention Type
Procedure
Intervention Name(s)
Upper Eyelid Blepharoplasty
Intervention Description
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
Primary Outcome Measure Information:
Title
Corneal nerve fiber density (CNFD)
Description
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNFD in fibers/mm2
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
Title
Corneal nerve branch density (CNBD)
Description
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in branches/mm2.
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
Title
Corneal nerve fiber length (CNFL)
Description
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; University of Manchester, Manchester, UK) was used to analyze CNBD in mm/mm2.
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
Title
Eyebrow position
Description
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
Title
Meibomian Gland Area Loss (MGAL)
Description
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.
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
Title
Non-invasive Tear Break-Up Time (NI-BUT)
Description
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.
Time Frame
Baseline / 1 Week / 1 Month / 1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Dericioğlu, M.D
Organizational Affiliation
Marmara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marmara University Pendik Research and Educational Hospital
City
Istanbul
State/Province
Pendik
ZIP/Postal Code
34899
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data supporting the study findings are available from the corresponding author upon request.
Learn more about this trial
Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
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