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

ISRCTN ISRCTN13156311
DOI https://doi.org/10.1186/ISRCTN13156311
ClinicalTrials.gov number NCT02071147
Secondary identifying numbers 14/02/050
Submission date
05/02/2014
Registration date
24/04/2014
Last edited
14/05/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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 doesn’t. 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

Contact information

Dr Andrew Frost
Scientific

C/O Research and Development Department
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom

Phone +44 (0) 1803 656635
Email sdhct.research@nhs.net

Study information

Study designSingle-centre two arms randomised single-blinded (nurse-blinded) study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRandomised trial of four to six week follow ups vs no medical follow up after uncomplicated cataract extraction
Study objectivesIs 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(s)NRES Committee South West - Frenchay; 18/12/2013; ref. 13/SW/0318
Health condition(s) or problem(s) studiedEyes – Cataract extraction
InterventionPathway 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 typeOther
Primary outcome measure1. 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 measures1. Post-operative complication rate difference between the two groups
2. Post-operative patient satisfaction between the two groups at 3 months
Overall study start date03/02/2014
Completion date01/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants400
Key inclusion criteria1. Adults aged >= 40 years
2. Scheduled for day-case cataract surgery
3. Able to give informed consent
Key exclusion criteria1. 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)
Date of first enrolment03/02/2014
Date of final enrolment01/12/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

C/O Research and Development Department,
Torquay
TQ2 7AA
United Kingdom

Sponsor information

South Devon Healthcare NHS Foundation Trust (UK)
Hospital/treatment centre

R&D Manager
Research & Development Department
Horizon Centre
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
England
United Kingdom

Phone +44 (0) 1803 656635
Email sdcht.research@nhs.net
ROR logo "ROR" https://ror.org/05374b979

Funders

Funder type

Research organisation

Torbay Medical Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

24/01/2018: No publications found, verifying study status with principal investigator.