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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Corneal nerve fiber length (CNFL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
All evaluations and data collection were performed by a blinded investigator.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than
- •Patients with dermatochalasis.
- •Patients who were suggested upper eyelid blepharoplasty for medical or cosmetic purposes.
排除标准
- •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.
结局指标
主要结局
Corneal nerve fiber length (CNFL)
时间窗: 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.
Meibomian Gland Area Loss (MGAL)
时间窗: 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.
Corneal nerve fiber density (CNFD)
时间窗: 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
Corneal nerve branch density (CNBD)
时间窗: 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.
Eyebrow position
时间窗: Baseline / 1 Week / 1 Month / 1 Year
Millimetric measurement was performed to evaluate the effect of blepharoplasty on eyebrow position.
Non-invasive Tear Break-Up Time (NI-BUT)
时间窗: 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.
次要结局
未报告次要终点