RCT of Follow up Following Cataract Extraction

May 18, 2015 updated by: Torbay and South Devon NHS Foundation Trust

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

Unknown

Conditions

Intervention / Treatment

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 (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Devon
      • Torquay, Devon, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay District General Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrew Frost, MBChB, MRCP, FRCOphth, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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)
Time Frame: 3 Months
3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Time Frame: 3 Months
3 Months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 21, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 25, 2014

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/02/050

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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