RCT of Follow up Following Cataract Extraction

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Other: No Clinical Follow up; Other: Quality of Life questionnaire; Other: Patient satisfaction Questionnaire

• Registration Number: NCT02071147
• Lead Sponsor: Torbay and South Devon NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-25
• Primary Completion: 2016-08-10
• Study Completion: 2023-08-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adults Aged >= 40 years
• Scheduled for day-case cataract surgery
• Able to give informed consent

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard clinical intervention	Patient satisfaction Questionnaire	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.
No Clinical Follow up	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.
No Clinical Follow up	Patient satisfaction Questionnaire	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.
Standard clinical intervention	Quality of Life questionnaire	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.
No Clinical Follow up	Quality of Life questionnaire	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.

Primary Outcome Measures

Name	Time	Method
Corrected distance visual acuity (VA)	3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires	3 Months

Secondary Outcome Measures

Name	Time	Method
Post operative complication rate between the two groups	3 Months
Post operative patient satisfaction between the two groups	3 months

Trial Locations

Locations (1)

Torbay District General Hospital; 🇬🇧 Torquay, Devon, United Kingdom