Optometric Follow-up After Cataract Surgery

Sponsor

Queen's University, Belfast (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04163926

Collaborator

Belfast Health and Social Care Trust (Other), Southern Health and Social Care Trust (Other)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Age-related Cataract	Procedure: Intervention Group cataract follow up Procedure: Usual Care consultant follow up	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised control trial (RCT) control versus usual careRandomised control trial (RCT) control versus usual care

Masking:

Single (Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Feb 28, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Sep 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention group - Post op follow up by trained optometrist 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 Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
Active Comparator: Usual care group - Consultant led post op follow up Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist	Procedure: Usual Care consultant follow up Usual care group - Consultant led post op follow up

Arm

Intervention/Treatment

Experimental: Intervention group - Post op follow up by trained optometrist

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

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

Active Comparator: Usual care group - Consultant led post op follow up

Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist

Procedure: Usual Care consultant follow up

Usual care group - Consultant led post op follow up

Outcome Measures

Primary Outcome Measures

Patient Satisfaction following different follow up to cataract surgery (Opthalmic led versus optometric follow up) [At 6 months]
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 [At 6 months]
The total cost per patient visit will be determined and compared
Patient safety [At 6 months]
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 [6 months]
IOP rise will be compared between the 2 groups in mmHg
Visual Acuity [6 months]
Visual acuity will be compared between the 2 groups
Post operative complications [6 months]
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.

Other Outcome Measures

Adherence [At 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.