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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.
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| Name | Class |
|---|---|
| Belfast Health and Social Care Trust | OTHER |
| Southern Health and Social Care Trust | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group - Post op follow up by trained optometrist | Experimental | Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic |
|
| Usual care group - Consultant led post op follow up | Active Comparator | Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention Group cataract follow up | Procedure | Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | The total cost per patient visit will be determined and compared | At 6 months |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | 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. | At 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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Randomised control trial (RCT) control versus usual care
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Outcome assessor will not know the study group assignment of participants.
| Usual Care consultant follow up | Procedure | Usual care group - Consultant led post op follow up |
|
| At 6 months |
| Intraocular pressure (IOP) rise | IOP rise will be compared between the 2 groups in mmHg | 6 months |
| Visual Acuity | Visual acuity will be compared between the 2 groups | 6 months |
| 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. | 6 months |
| D001519 |
| Behavior |