The Effect of Upper Blepharoplasty on Anatomical and Functional Aspects of Vision in the Early Postoperative Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Contrast sensitivity
研究概览
简要总结
Contrast sensitivity (CS) and tear film (TF) changes are noted in late postoperative period after upper blepharoplasty (UB), while the same was rarely investigated in the early postoperative period. The reason for aforementioned improvement of vision quality is unclear. Suggested explanations include changes in higher-order aberrations, elimination of the overlay effect created by excess skin on the upper eyelids and/or eyelashes directed toward the eyelid, or changes in corneal topography (CT) and keratometry.
Furthermore, there is no consensus on the best technique for UB. Due not only to different surgical techniques, but also to different methods of measuring the tear film quality, it is very difficult to quantify the aforementioned studies.
While changes in tear volume parameters and changes in tear film (TF) rupture have been investigated in detail, changes in the lipid layer have rarely been investigated.
According to previous studies, there are different findings about changes in CT after UB.
The aim of the research is to determine whether there are anatomical (CT) and functional (TF and CS) changes in subjects with functional dermatochalasis before the procedure and in a month-long postoperative period.
The research is conducted on examinees diagnosed by clinical examination with functional dermatochalasis with the exclusion of examinees with ocular or systemic conditions affecting TF, best corrected visual acuity or CT.
Detailed medical history and ophthalmologic examination will be performed with grading of the external appearance of the upper eyelids. All diseases and conditions that can lead to changes in CS, TF or corneal defects will be noted. Preoperatively all subjects will have CS recorded in photopic conditions, TF analysis and CT (Keratograph 5M, OCULUS Optikgeraete GmbH, Wetzlar, Germany). UB will be performed in the operating room at the UED. At first (seven days postoperatively) and second (one month postoperative) check-up a CS check will be performed at the UED and TF analysis and CT at Lens LTD.
详细描述
Dermatochalasis is an age-related condition characterized by the development of folds of excess skin on the upper eyelid with loss of skin elasticity. The mechanical pressure created by the accumulation of excess fat tissue and skin over the upper eyelid leads to a feeling of heaviness and narrowing of the peripheral visual field, which is an indication for surgical treatment. In addition to widening the field of vision, it has been noted that upper blepharoplasty (UB) also has an impact on the subjective improvement of vision postoperatively. Although no difference in best corrected visual acuity was observed pre- and postoperatively, it was noted that contrast sensitivity (CS) improves after UB, especially in the late postoperative period, while the same was rarely investigated in the early postoperative period. The exact reason for the postoperative increase in CS is not clear. Suggested explanations include changes in higher-order aberrations, elimination of the overlay effect created by excess skin on the upper eyelids and/or eyelashes directed toward the eyelid, or changes in corneal topography (CT) and keratometry.
Furthermore, there is no consensus on the best technique for UB. Due not only to different surgical techniques, but also to different methods of measuring the tear film quality, it is very difficult to quantify the aforementioned studies.
While changes in tear volume parameters and changes in tear film (TF) rupture have been investigated in detail, changes in the lipid layer have rarely been investigated.
According to previous studies, there are different findings about changes in CT after UB.
The aim of the research is to determine whether there are anatomical (CT) and functional (TF and CS) changes in subjects with functional dermatochalasis before the procedure and in a month-long postoperative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with functional dermatochalasis on the upper eyelid with subjective difficulties due to obstructing the upper part of visual field: swelling of the eyelids in the morning with difficulties in opening the eyes, use of the frontal musculature to be able to have at least a partial width of the field of vision in the upper part that is adequate for daily functioning, and headaches.
排除标准
- •History of corneal refractive surgery, pterygium, glaucoma, nuclear sclerosis > 4th degree, severe dry eye, age-related macular degeneration, neuro-ophthalmological diseases, use of hormone therapy, diabetic retinopathy or condition after panretinal photocoagulation. Corneal pathologies such as keratoconus and gross eyelid malposition conditions such as entropion, ectropion and marked laxity of the eyelids are also grounds for exclusion from the study.
结局指标
主要结局
Contrast sensitivity
时间窗: Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is five minutes
Measurement of contrast sensitivity using Pelli-Robson chart with best corrected visual acuity in photopic condions
次要结局
- Corneal topography(Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes)
- Tear film quality(Measurement will take place preoperatively, 7 days and one month postoperatively. Planned duration of the examination is thirty minutes)
研究者
Dunja Klepo
Principal investigator
Osijek University Hospital