An interventional study of Upper Eyelid Blepharoplasty in Dermatochalasis of Eyelid, Ocular Surface Disease and Meibomian Gland Dysfunction, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Marmara University · Not applicable, Interventional, and Prevention
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.
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
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Exclusion Criteria:
Only the skin excision was performed for upper eyelid dermatochalasis.
Procedure: Upper Eyelid Blepharoplasty
Skin plus muscle excision was performed for upper eyelid dermatochalasis.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Eyebrow position
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Time frame: 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.
Time frame: 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.
Time frame: Baseline / 1 Week / 1 Month / 1 Year
Plan to share: No — The data supporting the study findings are available from the corresponding author upon request.
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Marmara University