Optometric Follow-up After Cataract Surgery
Primary Purpose
Cataract, Age-related Cataract
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention Group cataract follow up
Usual Care consultant follow up
Sponsored by
About this trial
This is an interventional health services research trial for Cataract focused on measuring follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the Belfast Trust and Southern Trust
- Willing to participate and give informed consent.
Exclusion Criteria:
- Patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). Note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients.
- Patients that were not referred by an optometrist.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group - Post op follow up by trained optometrist
Usual care group - Consultant led post op follow up
Arm Description
Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic
Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist
Outcomes
Primary Outcome Measures
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
Patient satisfaction will be measured using the patient satisfaction questionnaire (PSQ)-18 at 6 months after surgery The scale include values for general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor and accessibility and convenience.
Each question is scored between 1 - 5. As some questions have reverse scoring (higher values indicate dissatisfaction) scores are reversed so a 5 will show highest satisfaction and 1 show lowest satisfaction.
Each item within the subscales will be averaged and results will be given for each of the 7 subscales
Secondary Outcome Measures
Cost
The total cost per patient visit will be determined and compared
Patient safety
Patient safety outcomes in the operative eye will include:
loss of visual acuity >=2 lines Intraocular pressure (IOP) rise >=8 millimetres of mercury (mmHg) post-operative complications as documented by the examining ophthalmologist.
Intraocular pressure (IOP) rise
IOP rise will be compared between the 2 groups in mmHg
Visual Acuity
Visual acuity will be compared between the 2 groups
Post operative complications
Post operative complications will be assessed qualitatively. Surgeons at the 6 month follow up will detail if cornea deep and quiet, wound is intact, intraocular lens centred, posterior capsule intact and clear, anterior vitreous quiet, posterior pole and retina remarkable, signs if infection, retained ens matter and other abnormalities recorded by the surgeon.
Full Information
NCT ID
NCT04163926
First Posted
August 7, 2019
Last Updated
September 13, 2022
Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, Southern Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT04163926
Brief Title
Optometric Follow-up After Cataract Surgery
Official Title
Optometric Versus Ophthalmic Follow up of Cataract Surgery Patients in Northern Ireland: A Mixed Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The RCT part of the study has been stopped. Due to other issues, funding, other trails and policy changes, the rct will not happen. Interviews will continue but RCT part will not.
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
September 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University, Belfast
Collaborators
Belfast Health and Social Care Trust, Southern Health and Social Care Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will investigate the effectiveness of an optometric follow up of cataract surgery versus an ophthalmic surgeon follow up. It will investigate patient satisfaction,safety and cost.
Detailed Description
The study will be a mixed-methods study, including a randomized controlled trial in which participants are randomized after cataract surgery to follow up to be consultant led follow up or conducted by a trained optometrist 4-6 weeks following surgery. All participants will then return 6 months after surgery for an additional follow-up visit with an ophthalmologist other than the operating surgeon with patient healthcare satisfaction (main outcome), cost-effectiveness and safety outcomes being measured. A subset of patients and local clinicians will also take part in a one-time, individual, semi-structured interview.
This research will test an alternative model of aftercare for cataract surgeries, which may reduce patient waiting time and inconvenience. In turn, this could help improve patient satisfaction and reduce costs for both patients and the National Health Service (NHS).
Participants will be recruited by operating surgeons. The research will take place in the hospital/clinic/optometrists' offices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Age-related Cataract
Keywords
follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial (RCT) control versus usual care
Masking
Outcomes Assessor
Masking Description
Outcome assessor will not know the study group assignment of participants.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group - Post op follow up by trained optometrist
Arm Type
Experimental
Arm Description
Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic
Arm Title
Usual care group - Consultant led post op follow up
Arm Type
Active Comparator
Arm Description
Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist
Intervention Type
Procedure
Intervention Name(s)
Intervention Group cataract follow up
Intervention Description
Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
Intervention Type
Procedure
Intervention Name(s)
Usual Care consultant follow up
Intervention Description
Usual care group - Consultant led post op follow up
Primary Outcome Measure Information:
Title
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
Description
Patient satisfaction will be measured using the patient satisfaction questionnaire (PSQ)-18 at 6 months after surgery The scale include values for general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor and accessibility and convenience.
Each question is scored between 1 - 5. As some questions have reverse scoring (higher values indicate dissatisfaction) scores are reversed so a 5 will show highest satisfaction and 1 show lowest satisfaction.
Each item within the subscales will be averaged and results will be given for each of the 7 subscales
Time Frame
At 6 months
Secondary Outcome Measure Information:
Title
Cost
Description
The total cost per patient visit will be determined and compared
Time Frame
At 6 months
Title
Patient safety
Description
Patient safety outcomes in the operative eye will include:
loss of visual acuity >=2 lines Intraocular pressure (IOP) rise >=8 millimetres of mercury (mmHg) post-operative complications as documented by the examining ophthalmologist.
Time Frame
At 6 months
Title
Intraocular pressure (IOP) rise
Description
IOP rise will be compared between the 2 groups in mmHg
Time Frame
6 months
Title
Visual Acuity
Description
Visual acuity will be compared between the 2 groups
Time Frame
6 months
Title
Post operative complications
Description
Post operative complications will be assessed qualitatively. Surgeons at the 6 month follow up will detail if cornea deep and quiet, wound is intact, intraocular lens centred, posterior capsule intact and clear, anterior vitreous quiet, posterior pole and retina remarkable, signs if infection, retained ens matter and other abnormalities recorded by the surgeon.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Adherence
Description
How well patients that have had cataract surgery follow advice for at home care (use of post-operative medication, self-report) and attending follow up medical appointments (as per patient records) will also be compared between the two groups.
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing cataract surgery in 1st or 2nd eye for age-related cataract, in the Belfast Trust and Southern Trust
Willing to participate and give informed consent.
Exclusion Criteria:
Patients judged by operative surgeon to be of high risk of loss of visual acuity in the operative eye (e.g. end stage glaucoma etc.). Note that patients with ocular comorbidity and previous surgery will not be routinely excluded, nor will monocular patients.
Patients that were not referred by an optometrist.
12. IPD Sharing Statement
Plan to Share IPD
No
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Optometric Follow-up After Cataract Surgery
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