Optometric Follow-up After Cataract Surgery

NCT04163926 | Withdrawn

• 1 other identifier: B17/29
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Age-related Cataract

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cost

  At 6 months

• Patient safety

  At 6 months

• Intraocular pressure (IOP) rise

  6 months

• Visual Acuity

  6 months

• Post operative complications

  6 months

Other Outcomes (1)

• Adherence

  At 6 months

Study Arms (2)

Intervention group - Post op follow up by trained optometrist

EXPERIMENTAL

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

Usual care group - Consultant led post op follow up

ACTIVE COMPARATOR

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

Procedure: Usual Care consultant follow up

Interventions

Intervention Group cataract follow up PROCEDURE

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

Intervention group - Post op follow up by trained optometrist

Usual Care consultant follow up PROCEDURE

Usual care group - Consultant led post op follow up

Usual care group - Consultant led post op follow up

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University, Belfast: lead
• Belfast Health and Social Care Trust: collaborator
• Southern Health and Social Care Trust: collaborator

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will not know the study group assignment of participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Model Details: Randomised control trial (RCT) control versus usual care

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: November 15, 2019
• Study Start: February 28, 2022
• Primary Completion: August 30, 2022
• Study Completion: September 28, 2022
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share