Clinical trial NCT04163926: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Age-related Cataract
Keywords: follow up
post surgery
patient satisfaction
optometrist
ophthalmologist
community care
Lead sponsor: Queen's University, Belfast
Sponsor class: OTHER
Collaborators: name: Belfast Health and Social Care Trust
name: Southern Health and Social Care Trust
First posted: 2019-11-15
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised control trial (RCT) control versus usual care
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)
timeFrame: At 6 months
Secondary outcomes:
measure: Cost
timeFrame: At 6 months
measure: Patient safety
timeFrame: At 6 months
measure: Intraocular pressure (IOP) rise
timeFrame: 6 months
measure: Visual Acuity
timeFrame: 6 months
measure: Post operative complications
timeFrame: 6 months
Other outcomes:
measure: Adherence
timeFrame: At 6 months
Locations:
Study officials:
References: