Ocular Coherence Tomography During Cataract Assessment

Age Related Macular Degeneration Clinical Trial

Official title:

Importance of Ocular Coherence Tomography During Cataract Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05287269
• Other study ID #: 2112020
• Status: Completed
• Start date: November 2, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2023
• Source: Brighton and Sussex University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: November 30, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 100 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
United Kingdom	Brighton & Sussex University Hospitals NHS Trust	Brighton	Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Brighton and Sussex University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of occult macular pathologies in the eye referred for cataract surgery	Comparison of slitlamp biomicroscopy fundus finding with ocular coherence tomography (OCT) scan of the macula	During the cataract assessment clinic
Secondary	Incidence of macular pathologies in the fellow eye	Noting the incidence of macular pathologies noted on OCT	During the cataract assessment clinic