Optometric Follow-up After Cataract Surgery

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04163926
• Other study ID #: B17/29
• Status: Withdrawn
• Phase: N/A
• Start date: February 28, 2022
• Est. completion date: September 28, 2022

Study information

• Verified date: September 2022
• Source: Queen's University, Belfast
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 28, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Intervention

Procedure:
• Intervention Group cataract follow up
Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
• Usual Care consultant follow up
Usual care group - Consultant led post op follow up

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Queen's University, Belfast	Belfast Health and Social Care Trust, Southern Health and Social Care Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	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.	At 6 months
Primary	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	Cost	The total cost per patient visit will be determined and compared	At 6 months
Secondary	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
Secondary	Intraocular pressure (IOP) rise	IOP rise will be compared between the 2 groups in mmHg	6 months
Secondary	Visual Acuity	Visual acuity will be compared between the 2 groups	6 months
Secondary	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