Optometric Follow-up After Cataract Surgery

NCT ID: NCT04163926

Last Updated: 2022-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-28

Study Completion Date

2022-09-28

Brief Summary

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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

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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.

Conditions

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Cataract Age-related Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised control trial (RCT) control versus usual care
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

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

Study Groups

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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

Group Type EXPERIMENTAL

Intervention Group cataract follow up

Intervention Type PROCEDURE

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

Usual care group - Consultant led post op follow up

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

Group Type ACTIVE_COMPARATOR

Usual Care consultant follow up

Intervention Type PROCEDURE

Usual care group - Consultant led post op follow up

Interventions

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Intervention Group cataract follow up

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

Intervention Type PROCEDURE

Usual Care consultant follow up

Usual care group - Consultant led post op follow up

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role collaborator

Southern Health and Social Care Trust

OTHER_GOV

Sponsor Role collaborator

Queen's University, Belfast

OTHER

Sponsor Role lead

Responsible Party

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Nathan Congdon

Chief Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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B17/29

Identifier Type: -

Identifier Source: org_study_id

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