Dry Eye Clinical Trial
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
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 |
Verified date | September 2022 |
Source | Marmara University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Marmara University Pendik Research and Educational Hospital | Istanbul | Pendik |
Lead Sponsor | Collaborator |
---|---|
Marmara University |
Turkey,
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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