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CompletedNCT05287269Updated Nov 3, 2023

Ocular Coherence Tomography During Cataract Assessment

An observational study in Cataract Senile, Macula Hole and Epiretinal Membrane, sponsored by Brighton and Sussex University Hospitals NHS Trust. Completed at 1 site in United Kingdom. Open to participants aged Up to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by Brighton and Sussex University Hospitals NHS Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
626
Ages
Up to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • cataract, macular pathology, ocular coherence tomography
03

In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's enrollment of 626 is above the median of 50 across 43 observational studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Brighton and Sussex University Hospitals NHS Trust is the lead sponsor of 22 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients referred for cataract surgery

Exclusion criteria

Exclusion Criteria:

  • Patients unable to attend the cataract assessment clinic
  • Morbid patients who cannot be assessed on OCT or slit lamp
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
626 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testOcular 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).

    Also known as: Swept Source ocular coherence tomography

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: During the cataract assessment clinic

Secondary outcomes

  1. Incidence of macular pathologies in the fellow eye

    Noting the incidence of macular pathologies noted on OCT

    Time frame: During the cataract assessment clinic

07

Study locations

1 site
  • Brighton & Sussex University Hospitals NHS Trust
    Brighton, Sussex BN2 5BF, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05287269
Lead sponsor
Brighton and Sussex University Hospitals NHS Trust
Responsible party
Sponsor
First posted
Mar 18, 2022
Start date
Nov 2, 2020
Primary completion
Nov 6, 2020
Completion
Nov 30, 2020
Last update
Nov 3, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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