ISRCTN - ISRCTN13156311: Randomised trial of four to six week follow ups vs no medical follow up after uncomplicated cataract extraction

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

NCT02071147

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 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