- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05528016
Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty
September 1, 2022 updated by: Marmara University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pendik
-
Istanbul, Pendik, Turkey, 34899
- Marmara University Pendik Research and Educational Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Skin-Only Blepharoplasty
Only the skin excision was performed for upper eyelid dermatochalasis.
|
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
|
Active Comparator: Skin+Muscle Blepharoplasty
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
|
Blepharoplasty is a procedure that the skin, orbicularis oculi muscle, and fat pads are excised to treat visual field loss caused by dermatochalasis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Corneal nerve fiber density (CNFD)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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)
Time Frame: Baseline / 1 Week / 1 Month / 1 Year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Volkan Dericioğlu, M.D, Marmara University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2021
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
August 1, 2022
Study Registration Dates
First Submitted
August 31, 2022
First Submitted That Met QC Criteria
September 1, 2022
First Posted (Actual)
September 6, 2022
Study Record Updates
Last Update Posted (Actual)
September 6, 2022
Last Update Submitted That Met QC Criteria
September 1, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Connective Tissue Diseases
- Skin Diseases, Genetic
- Lacrimal Apparatus Diseases
- Keratoconjunctivitis
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Eyelid Diseases
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Meibomian Gland Dysfunction
- Cutis Laxa
Other Study ID Numbers
- 09.2022.102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data supporting the study findings are available from the corresponding author upon request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dry Eye
-
Gordon Schanzlin New VisionCompletedDry Eye | Dry Eye Disease | Evaporative Dry Eye | Kerato Conjunctivitis Sicca | Evaporative Dry Eye Disease | Dry Eye, EvaporativeUnited States
-
Kao (Taiwan) CorporationChang Gung Memorial HospitalCompletedEye Fatigue | Dry Eye SymptomTaiwan
-
Alcon ResearchCompletedVisual Performance | Dry Eye Symptoms
-
Alcon ResearchCompletedModerate to Severe Dry Eye
-
Singapore National Eye CentreCompleted
-
Senju Pharmaceutical Co., Ltd.CompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
AllerganCompletedDry Eye Syndrome | Dry Eye DiseaseUnited States
-
Bausch & Lomb IncorporatedCompletedDry Eye Disease (DED)United States
-
Centre for Contact Lens ResearchCoopervision, Inc.CompletedContact Lens Related Dry EyeCanada
-
Singapore National Eye CentreCompleted
Clinical Trials on Upper Eyelid Blepharoplasty
-
Benha UniversityUnknownEyelid DiseasesUnited Arab Emirates
-
Benha UniversityUnknownEyelid DiseasesUnited Arab Emirates
-
Federal University of São PauloTerminated
-
Benha UniversityUnknown
-
Xijing HospitalUnknownSubbrow Blepharoplasty;Double Eyelid Surgery; Orbicularis Oculi MuscleChina
-
Benha UniversityRecruiting
-
Instituto de Olhos de GoianiaCentro de Referência em OftalmologiaCompletedEfficacy of a Technique (Brassiere Sutures)
-
Osijek University HospitalRecruitingContrast Sensitivity | Excess Skin of Both Eyelids | Tear Film Insufficiency of Both Eyes | Corneal TopographyCroatia
-
Medical University of ViennaCompleted