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Optometric Follow-up After Cataract Surgery

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04163926
Enrollment
0
Registered
2019-11-15
Start date
2022-02-28
Completion date
2022-09-28
Last updated
2022-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cataract, Cataract

Keywords

follow up, post surgery, patient satisfaction, optometrist, ophthalmologist, community care

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.

Interventions

PROCEDUREIntervention Group cataract follow up

Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery

PROCEDUREUsual Care consultant follow up

Usual care group - Consultant led post op follow up

Sponsors

Belfast Health and Social Care Trust
CollaboratorOTHER
Southern Health and Social Care Trust
CollaboratorOTHER_GOV
Queen's University, Belfast
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor will not know the study group assignment of participants.

Intervention model description

Randomised control trial (RCT) control versus usual care

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up)At 6 monthsPatient 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

MeasureTime frameDescription
CostAt 6 monthsThe total cost per patient visit will be determined and compared
Patient safetyAt 6 monthsPatient 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.
Post operative complications6 monthsPost 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.
Intraocular pressure (IOP) rise6 monthsIOP rise will be compared between the 2 groups in mmHg
Visual Acuity6 monthsVisual acuity will be compared between the 2 groups

Other

MeasureTime frameDescription
AdherenceAt 6 monthsHow 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026