- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05287269
Ocular Coherence Tomography During Cataract Assessment
Importance of Ocular Coherence Tomography During Cataract Assessment
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sussex
-
Brighton, Sussex, United Kingdom, BN2 5BF
- Brighton & Sussex University Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2112020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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