The Role of Bandage Contact Lens in Post-operative Patients Undergoing Fasanella Servat Ptosis Repair
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient's pain/discomfort
研究概览
简要总结
This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary.
详细描述
This study is being conducted to determine whether the use of bandage contact lens after ptosis surgery provides any benefits for the patient or is unnecessary. The investigators hope to show through questionnaires based on the patient's experience after their surgery to see if the bandage contact lens has provided any benefit for the patient. This is a randomized control trial in which patients undergoing bilateral ptosis surgery (Fasanella servat procedure) will have one of their eyes randomized to receive a bandage contact lens after surgery while the other eye will not receive anything.In this randomized control trial, patients requiring surgery with bilateral ptosis will have one eye randomized to receive a bandage contact lens whereas the other eye will not after their surgery. Follow up will occur in one week where the outcomes will be obtained through questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The investigator will place a contact lens on both eyes and immediately take it off from one (this will be the sham lens eye). Randomization of the lens placement will be determined by a flip of a coin (heads - keep lens on right eye. Tails - keep lens on left eye). Investigator will randomly generate for each patient whether the contact lens will be kept on right or left eye, sham contact lens will be placed on other eye, placing it and immediately removing it. Therefore, the patient will not know which eye has a lens.
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients who have bilateral ptosis (drooping eyelids) and will require surgery to correct this
排除标准
- •patient having any other eye related pathologies
研究组 & 干预措施
Bandage contact lens
Placing a bandage contact lens in one eye.
干预措施: Bandage contact lens (Device)
Sham contact lens (immediate removal)
Sham contact lens will be placed on other eye, placing it and immediately removing it so patient does not know which eye will have a bandage contact lens.
结局指标
主要结局
Patient's pain/discomfort
时间窗: One week post-operation.
This will be obtained using the Eye Sensations Scale where the patient can select a box from None, Mild, Moderate, Severe, to Extreme.
次要结局
- Blurry vision(One week post-operation.)
研究者
John Harvey
Director of Oculoplastic, Reconstructive, Lacrimal and Orbital Service
St. Joseph's Healthcare Hamilton