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OpenTrials
Completed

NCT Number: NCT02071147

RCT of Follow up Following 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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Torbay District General Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

No Clinical Follow up

Other

Quality of Life Questionnaire

Other

Other names: VQOL

Patient satisfaction Questionnaire

Other

Conducted at Research clinic.

Primary outcomes

  1. Corrected distance visual acuity (VA)

    Time frame: 3 Months

  2. Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires

    Time frame: 3 Months

Secondary outcomes

  1. Post operative complication rate between the two groups

    Time frame: 3 Months

  2. Post operative patient satisfaction between the two groups

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Torbay and South Devon NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2023
First posted
Feb 25, 2014
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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