RCT of Follow up Following Cataract Extraction
Primary Purpose
Cataract
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
No Clinical Follow up
Quality of Life questionnaire
Patient satisfaction Questionnaire
Sponsored by
About this trial
This is an interventional supportive care trial for Cataract focused on measuring Follow-up, No follow-up, removal, Randomised Controlled Trial, 6 Weeks
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).
Sites / Locations
- Torbay District General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Standard clinical intervention
No Clinical Follow up
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Corrected distance visual acuity (VA)
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Secondary Outcome Measures
Post operative complication rate between the two groups
Post operative patient satisfaction between the two groups
Full Information
NCT ID
NCT02071147
First Posted
February 21, 2014
Last Updated
May 18, 2015
Sponsor
Torbay and South Devon NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02071147
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Torbay and South Devon NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Follow-up, No follow-up, removal, Randomised Controlled Trial, 6 Weeks
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard clinical intervention
Arm Type
Other
Arm Description
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.
Arm Title
No Clinical Follow up
Arm Type
Other
Arm Description
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
Intervention Name(s)
No Clinical Follow up
Intervention Type
Other
Intervention Name(s)
Quality of Life questionnaire
Other Intervention Name(s)
VQOL
Intervention Type
Other
Intervention Name(s)
Patient satisfaction Questionnaire
Intervention Description
Conducted at Research clinic.
Primary Outcome Measure Information:
Title
Corrected distance visual acuity (VA)
Time Frame
3 Months
Title
Vision-related quality of life impairment measures are the VCM1 and Catquest questionnaires
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Post operative complication rate between the two groups
Time Frame
3 Months
Title
Post operative patient satisfaction between the two groups
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Frost, MBchB, MRCP, FRCOphth, PHD
Organizational Affiliation
Torbay and South Devon NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Torbay District General Hospital
City
Torquay
State/Province
Devon
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fiona Roberts, PhD
Phone
+44 (0) 1803 656635
Email
fiona.roberts@nhs.net
First Name & Middle Initial & Last Name & Degree
Manger Of Research and Development
Phone
+44 (0) 1803 656635
Email
sdhct.research@nhs.net
First Name & Middle Initial & Last Name & Degree
Andrew Frost, MBChB, MRCP, FRCOphth, PhD
12. IPD Sharing Statement
Learn more about this trial
RCT of Follow up Following Cataract Extraction
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