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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Other: Quality of Life questionnaire; Other: Patient satisfaction Questionnaire; Other: No Clinical Follow up

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Torquay, Devon, United Kingdom, TQ2 7AA
      • Torbay District General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Quality of Life questionnaire; Other Names: VQOL; Other: Patient satisfaction Questionnaire; Conducted at Research clinic.
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.	Other: Quality of Life questionnaire; Other Names: VQOL; Other: Patient satisfaction Questionnaire; Conducted at Research clinic.; Other: No Clinical Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Post operative complication rate between the two groups	3 Months
Post operative patient satisfaction between the two groups	3 months

Collaborators and Investigators

• Sponsor: Torbay and South Devon NHS Foundation Trust
• Investigators: Principal Investigator: Andrew Frost, MBchB, MRCP, FRCOphth, PHD, Torbay and South Devon NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2014
• Primary Completion (Actual): August 10, 2016
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 24, 2014
• First Posted (Estimated): February 25, 2014

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Follow-up; Randomised Controlled Trial; removal; No follow-up; 6 Weeks
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 14/02/050