Ocular Coherence Tomography During Cataract Assessment

NCT ID: NCT05287269

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 626 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2020-11-30

Brief Summary

Many patients will have underlying maculopathy present when undergoing cataract surgery, which are not visible on fundoscopy alone. Knowledge of this underlying pathology will allow an improved consenting process and discussion with the patient regarding the risks, visual prognosis and recovery following cataract surgery. Incidental findings in the fellow eye would also allow for improved diagnosis and management of these patients without adding significant additional time to specialist high volume cataract assessment clinics.

Detailed Description

The majority of anterior segment pathology may be diagnosed with simple slit lamp biomicroscopy, but posterior segment pathology may not be quite so obvious and can be missed on simple examination especially if a visually significant cataract is present impeding the view. There is also a degree of subjectivity from how much the cataract impairs the vision in comparison to the other elements of the optical pathway within the eye, and whilst there is no single way to evaluate this.

Optical coherence tomography (OCT) has been widely present in ophthalmology clinics since it's development 20 years ago although it is not commonly used in all units for the pre-operative assessment of patients referred for cataract surgery in high volume set ups such as the National Health Service (NHS) in the United Kingdom. There may still be reluctance to use OCT in a normal cataract assessment clinic as it may be perceived as an additional step that decreases time efficiency and increase financial investment in the services.

In this study we sought to investigate the prevalence of retinal pathology in the patient cohort, the comparison of subjective clinical slit lamp fundoscopy assessmenet with OCT findings and the co-incidental OCT findings in the fellow eye at the time of cataract assessment. OCT was chosen as the most efficient way to support clinicians in the assessment clinics, and to see if the addition of this step added value to the patient consultation and pre-operative assessment.

Conditions

Cataract Senile; Macula Hole; Epiretinal Membrane; Age Related Macular Degeneration; Vitreomacular Traction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ocular Coherence Tomography

OCT images were recorded as a fast macular radial line scan with captured on either Heidelberg Spectralis (Heidelberg Engineering GmbH, Germany) or Topcon DRI Triton (Topcon Medical Systems inc. USA).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Swept Source ocular coherence tomography

Eligibility Criteria

Inclusion Criteria

• Patients referred for cataract surgery

Exclusion Criteria

• Patients unable to attend the cataract assessment clinic
• Morbid patients who cannot be assessed on OCT or slit lamp

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brighton and Sussex University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brighton & Sussex University Hospitals NHS Trust

Brighton, Sussex, United Kingdom

Countries

United Kingdom

Other Identifiers

2112020

Identifier Type: -

Identifier Source: org_study_id