Ocular Coherence Tomography During Cataract Assessment

Importance of Ocular Coherence Tomography During Cataract Assessment

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.

Study Overview

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.

Study Type

Observational

Enrollment (Actual)

626

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sussex
      • Brighton, Sussex, United Kingdom, BN2 5BF
        • Brighton & Sussex University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This was a prospective cross-sectional study of 626 consecutive patients attending cataract assessment clinics at the Sussex Eye Hospital between 2/11/20 and 6/11/20. ]As part of work to decrease waiting times for patients in the wake of the first wave of COVID-19 pandemic and the shutdown of non-emergency services, a week of activity dedicated to cataract assessment was undertaken at Brighton & Sussex University Hospitals NHS trust between 2nd and 6th November 2020.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of occult macular pathologies in the eye referred for cataract surgery
Time Frame: During the cataract assessment clinic
Comparison of slitlamp biomicroscopy fundus finding with ocular coherence tomography (OCT) scan of the macula
During the cataract assessment clinic

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of macular pathologies in the fellow eye
Time Frame: During the cataract assessment clinic
Noting the incidence of macular pathologies noted on OCT
During the cataract assessment clinic

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2020

Primary Completion (Actual)

November 6, 2020

Study Completion (Actual)

November 30, 2020

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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