An interventional study of No Clinical Follow up and Quality of Life questionnaire in Cataract, sponsored by Torbay and South Devon NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Torbay and South Devon NHS Foundation Trust · Not applicable, Interventional, and Supportive care
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.
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.
1,726 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 1,171 interventional studies indexed under Cataract.
Browse Cataract studies →Torbay and South Devon NHS Foundation Trust is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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: 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.
Other: No Clinical Follow up · Other: Quality of Life questionnaire · Other: Patient satisfaction Questionnaire
Also known as: VQOL
Conducted at Research clinic.
Corrected distance visual acuity (VA)
Time frame: 3 Months
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Time frame: 3 Months
Post operative complication rate between the two groups
Time frame: 3 Months
Post operative patient satisfaction between the two groups
Time frame: 3 months
Ran from Feb 2014 to primary completion in Aug 2016, 30 months.
Of 316 non-industry interventional studies with no phase under Cataract, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 30 months is above that.
Counting every sponsor, half of 501 studies reached it within 17 months; a quarter within 9 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Torbay and South Devon NHS Foundation Trust