Optometric Follow-up After Cataract Surgery

Not Applicable

Withdrawn

• Conditions: Age-related Cataract; Cataract
• Interventions: Procedure: Usual Care consultant follow up; Procedure: Intervention Group cataract follow up

• Registration Number: NCT04163926
• Lead Sponsor: Queen's University, Belfast

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.

Study Timeline

• Study First Submitted: 2019-08-07
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-15
• Study Start: 2022-02-28
• Primary Completion: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15
• Study Completion: 2022-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care group - Consultant led post op follow up	Usual Care consultant follow up	Follow-up at 4-6 weeks after surgery led by consultant ophthalmologist
Intervention group - Post op follow up by trained optometrist	Intervention Group cataract follow up	Intervention group will have cataract follow up conducted by a trained optometrist 4-6 weeks after surgery in community clinic

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Cost	At 6 months	The total cost per patient visit will be determined and compared
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.
Intraocular pressure (IOP) rise	6 months	IOP rise will be compared between the 2 groups in mmHg
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.