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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05528016
Other study ID # 09.2022.102
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2021
Est. completion date August 1, 2022

Study information

Verified date September 2022
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Turkey Marmara University Pendik Research and Educational Hospital Istanbul Pendik

Sponsors (1)

Lead Sponsor Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Eyebrow position Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position. Baseline / 1 Week / 1 Month / 1 Year
Primary Meibomian Gland Area Loss (MGAL) Phoenix-Meibography Imaging software that is available in the SiriusĀ® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate meibomian gland area loss in percentage. Baseline / 1 Week / 1 Month / 1 Year
Primary Non-invasive Tear Break-Up Time (NI-BUT) Phoenix-Meibography Imaging software that is available in the SiriusĀ® Scheimpflug topographer (Sirius, CSO, Italy) was used to evaluate non-invasive tear break-up time in seconds. Baseline / 1 Week / 1 Month / 1 Year
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