Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2014-02-28
2023-08-10
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
Quality of Life questionnaire
Patient satisfaction Questionnaire
Conducted at Research clinic.
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
Quality of Life questionnaire
Patient satisfaction Questionnaire
Conducted at Research clinic.
Interventions
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No Clinical Follow up
Quality of Life questionnaire
Patient satisfaction Questionnaire
Conducted at Research clinic.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for day-case cataract surgery
* Able to give informed consent
Exclusion Criteria
* 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).
40 Years
ALL
No
Sponsors
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Torbay and South Devon NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Andrew Frost, MBchB, MRCP, FRCOphth, PHD
Role: PRINCIPAL_INVESTIGATOR
Torbay and South Devon NHS Foundation Trust
Locations
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Torbay District General Hospital
Torquay, Devon, United Kingdom
Countries
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Other Identifiers
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14/02/050
Identifier Type: -
Identifier Source: org_study_id