Optometric Follow-up After Cataract Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Optometric Versus Ophthalmic Follow up of Cataract Surgery Patients in Northern Ireland: A Mixed Methods Study

Conditions
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Cataract, Age-related Cataract

Intervention / Treatment
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* Procedure: Intervention Group cataract follow up
* Procedure: Usual Care consultant follow up


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised control trial (RCT) control versus usual care
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group - Post op follow up by trained optometrist<br>Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic | Procedure: Intervention Group cataract follow up<br>* Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery<br>|
| Active Comparator: Usual care group - Consultant led post op follow up<br>Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist | Procedure: Usual Care consultant follow up<br>* Usual care group - Consultant led post op follow up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care