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
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 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
Contact information
Scientific
C/O Research and Development Department
Torbay District General Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
| Phone | +44 (0) 1803 656635 |
|---|---|
| sdhct.research@nhs.net |
Study information
| Study design | Single-centre two arms randomised single-blinded (nurse-blinded) study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised trial of four to six week follow ups vs no medical follow up after uncomplicated cataract extraction |
| Study objectives | 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(s) | NRES Committee South West - Frenchay; 18/12/2013; ref. 13/SW/0318 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 03/02/2014 |
| Completion date | 01/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Adults aged >= 40 years 2. Scheduled for day-case cataract surgery 3. Able to give informed consent |
| Key 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) |
| Date of first enrolment | 03/02/2014 |
| Date of final enrolment | 01/12/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TQ2 7AA
United Kingdom
Sponsor information
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 |
|---|---|
| sdcht.research@nhs.net | |
"ROR" |
https://ror.org/05374b979 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
