Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Corrected distance visual acuity (VA)
研究概览
简要总结
Purpose:
To examine the safety of omitting the routine postoperative eye clinic review following phacoemulsification cataract surgery.
Background:
Approximately 300000 cataract extractions are performed annually in the NHS in England, requiring a similar number of post-operative visits, the majority of which result in no change in management. A conservative estimate of 70% of visits being unnecessary suggests a potential saving to the NHS of approximately £10M annually.
What's involved:
The study involves some questionnaires during the duration of the study. These include questionnaires relating to the quality of life of the patient (conducted before the operation, and at the 3 month research clinic) and a patient satisfaction questionnaire. There is also a research clinic 3 months following the operation.
What are the risks/benefits:
There are no real personal benefits to patients on the trial. The trial aims to provide very important information regarding the safety of discharging patients immediately after surgery. However the trial could potentially save many thousands of unnecessary hospital visits each year.
详细描述
Method:
The method presented is based on the method employed successfully by one of the applicants in an earlier stuy of the first day postoperative review following cataract surgery which has been peer-reviewed and published in the scientific literature. An earlier draft has been presented to a patient panel and has the benefit of external review by a potential steering group.
Patients undergoing routine elective phacoemulsification cataract surgery will be randomly assigned to either a routine review at 4-6 weeks post-operatively (routine care) or to be discharged from the cataract service immediately post-operatively. All patients will be advised to see their own optometrist at 4-6 weeks for new spectacles if appropriate and will then be reviewed in a research clinic at 3 months post operatively.
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 (Care Provider)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults Aged >= 40 years
- •Scheduled for day-case cataract surgery
- •Able to give informed consent
排除标准
- •Unable to provide written informed consent
- •Unable to visit their optometrist post operatively
- •Patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within three months of their operation (including significant diabetic retinopathy, wet age-related macular degeneration (AMD) on treatment, severe/end-stage glaucoma, previous retinal detachment or vitrectomy)
- •Patients undergoing another simultaneous ophthalmic procedure
- •Patients who suffer from an intra-operative complication requiring early postoperative evaluation (identified at surgery).
研究组 & 干预措施
Standard clinical intervention
Patients reviewed at 6 weeks (+/- 1 week) as is our normal practice and recalled for a further evaluation if deemed appropriate. Patients will be instructed to visit their optometrist once their eye has fully recovered from the operation for provision of glasses.
干预措施: Quality of Life questionnaire (Other)
Standard clinical intervention
Patients reviewed at 6 weeks (+/- 1 week) as is our normal practice and recalled for a further evaluation if deemed appropriate. Patients will be instructed to visit their optometrist once their eye has fully recovered from the operation for provision of glasses.
干预措施: Patient satisfaction Questionnaire (Other)
No Clinical Follow up
No routine follow-up appointment is made. Patients will be instructed to visit their optometrist between 6-8 weeks post-operative for review of the patient's glasses.
干预措施: No Clinical Follow up (Other)
No Clinical Follow up
No routine follow-up appointment is made. Patients will be instructed to visit their optometrist between 6-8 weeks post-operative for review of the patient's glasses.
干预措施: Quality of Life questionnaire (Other)
No Clinical Follow up
No routine follow-up appointment is made. Patients will be instructed to visit their optometrist between 6-8 weeks post-operative for review of the patient's glasses.
干预措施: Patient satisfaction Questionnaire (Other)
结局指标
主要结局
Corrected distance visual acuity (VA)
时间窗: 3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
时间窗: 3 Months
次要结局
- Post operative complication rate between the two groups(3 Months)
- Post operative patient satisfaction between the two groups(3 months)