NCT02071147

RCT of Follow up Following Cataract Extraction

Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Torbay and South Devon NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
OTHER	No Clinical Follow up
OTHER	Quality of Life questionnaire
OTHER	Patient satisfaction Questionnaire	Conducted at Research clinic.

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-08-10
• Completion: 2023-08-10
• First posted: 2014-02-25
• Last updated: 2024-11-29

Locations

1 site across 1 country: United Kingdom