Clinical trial NCT02071147: RCT of Follow up Following Cataract Extraction
Official title: Randomised Trial of Four to Six Week Follow Ups vs no Medical Follow up After Uncomplicated Cataract Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Follow-up
No follow-up
removal
Randomised Controlled Trial
6 Weeks
Lead sponsor: Torbay and South Devon NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Corrected distance visual acuity (VA)
timeFrame: 3 Months
measure: Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
timeFrame: 3 Months
Secondary outcomes:
measure: Post operative complication rate between the two groups
timeFrame: 3 Months
measure: Post operative patient satisfaction between the two groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Torquay
country: United Kingdom
facility: Torbay District General Hospital
state: Devon
Study officials:
affiliation: Torbay and South Devon NHS Foundation Trust
name: Andrew Frost, MBchB, MRCP, FRCOphth, PHD
role: PRINCIPAL_INVESTIGATOR
References: