Plain English Summary
Background and study aims
At the moment, most patients who have cataract surgery visit the eye clinic 4-6 weeks after their operation. Some doctors would say that this is not necessary, as the eye will usually have healed very well by this time. We would like to conduct a study to check that discharging certain patients immediately after their cataract surgery is safe. We would only discharge those patients in whom cataract surgery was straightforward, and those patients with no other eye problems. This would cut down on unnecessary visits to the eye clinic. Advice and assessment for any problems or concerns after the surgery would of course still always be available by contacting the eye clinic as usual.
Who can participate?
Participants will be patients who have a routine cataract operation in the near future.
What does the study involve?
Patients are randomly allocated to one of two groups: one group visits the clinic after the operation and the other doesnt. The study involves some questionnaires during 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 possible benefits and risks of participating?
There are no real personal benefits to participating patients. The study aims to provide very important information regarding the safety of discharging patients immediately after surgery. However, the study could potentially save many thousands of unnecessary hospital visits each year. The vast majority of patients who undergo cataract surgery have a good result whether they are followed up in clinic or not. There is only a very small chance of a post-operative problem not being picked up regardless of whether there is follow up or not. Serious problems following such procedures are rare and they are usually obvious to the patient as they generate new symptoms. Should any serious complication occur the patient will be able to attend eye clinic to receive guidance or treatment. Patients in the study are able to contact the eye clinic for advice or to request a clinic appointment.
Where is the study run from?
Torbay District General Hospital, UK.
When is the study starting and how long is it expected to run for?
The study started in February 2014 and is expected to last for 2 years.
Who is funding the study?
Torbay Medical Research Fund (UK).
Who is the main contact?
Mr Andrew Frost
Phone: +44 (0)1803 656635
Email: sdhct.research@nhs.net
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andrew Frost
ORCID ID
Contact details
C/O Research and Development Department
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0) 1803 656635
sdhct.research@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
14/02/050
Study information
Scientific title
Randomised trial of four to six week follow ups vs no medical follow up after uncomplicated cataract extraction
Acronym
Study hypothesis
Is it safe to discharge patients straight to their optometrist following routine cataract extraction rather than reviewing them in the hospital eye clinic post-operatively?
Ethics approval
NRES Committee South West - Frenchay; 18/12/2013; ref. 13/SW/0318
Study design
Single-centre two arms randomised single-blinded (nurse-blinded) study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Eyes Cataract extraction
Intervention
Pathway 1 (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.
Pathway 2 (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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. The primary outcome is corrected distance visual acuity (VA). The primary end point will be VA after 3 months of follow up
2. The primary outcome vision-related quality of life impairment measures are the VCM1 and catquest questionnaires after 3 months of follow up
Secondary outcome measures
1. Post-operative complication rate difference between the two groups
2. Post-operative patient satisfaction between the two groups at 3 months
Overall trial start date
03/02/2014
Overall trial end date
01/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adults aged >= 40 years
2. Scheduled for day-case cataract surgery
3. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant exclusion criteria
1. Unable to provide written informed consent
2. Unable to visit their optometrist post-operatively
3. Patients with ocular comorbidity that may be affected by cataract surgery or who require monitoring within 3 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)
4. Patients undergoing another simultaneous ophthalmic procedure
5. Patients who suffer from an intra-operative complication requiring early post-operative evaluation (identified at surgery)
Recruitment start date
03/02/2014
Recruitment end date
01/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
C/O Research and Development Department,
Torquay
TQ2 7AA
United Kingdom
Sponsor information
Organisation
South Devon Healthcare NHS Foundation Trust (UK)
Sponsor details
R&D Manager
Research & Development Department
Horizon Centre
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
+44 (0) 1803 656635
sdcht.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Torbay Medical Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary