A Comparison of Patient Perceptions Undergoing Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) vs Refractive Laser-Assisted Immediately Sequential Bilateral Cataract Surgery (ReLA-ISBCS)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
研究概览
简要总结
The focus of this study is to assess the differences in patient perceptions of pain undergoing cataract surgery by using the Refractive Laser-Assisted Cataract Surgery (ReLACS) technique compared to the standard Manual Cataract Surgery (MCS) technique using an immediately sequential bilateral approach. This study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the ReLACS technique. The importance of this study is appreciated patient perception of pain during ReLACS, which is an emerging technique for cataract surgery and has been sparsely reported on to date. This investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both ReLACS and MCS at Uptown Eye specialist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing uncomplicated cataract surgery with either surgical technique (M-ISBCS or ReLA-ISBCS)
- •Patients who require surgery in both eyes by the same surgeon
- •Able to understand English and complete a pain assessment (NRS)
排除标准
- •Deafness or communication disorder, known Dementia, Severe COPD/Asthma (severe lung disorder), Severe OSA, Psychiatric or Anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery
- •Pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy)
- •Pre-existing uncontrolled glaucoma/high IOP
- •Intraoperative complications or non-routine cataracts (eg. Sutures, excessive time of surgery)
- •Any patient who requires Deep Sedation (Propofol), GA or preOP Ativan
- •Patients under 40, severe obesity (BMI >35)
- •Chronic pain/narcotics/recreational or medical marijuana
结局指标
主要结局
Pain Perception between Manual Immediately Sequential Bilateral Cataract Surgery (M-ISBCS) and Refractive Laser-Assisted Immediately Sequential Cataract Surgery (ReLA-ISCS)
时间窗: 1 year
Pain perceptions of patients undergoing M-IBCS vs ReLA-ISBCS will be measured using the Numerical Rating Scale (NRS) with pain ratings from 0 to 10.
次要结局
- Effects of Early vs Standard administration of topical neurolept anesthesia on pain perception(1 Year)