NCT05287269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
626

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2020

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2020

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
Last Updated

November 3, 2023

Status Verified

November 1, 2023

Enrollment Period

4 days

First QC Date

March 10, 2022

Last Update Submit

November 2, 2023

Conditions

Keywords

cataract, macular pathology, ocular coherence tomography

Outcome Measures

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

    During the cataract assessment clinic

Secondary Outcomes (1)

  • Incidence of macular pathologies in the fellow eye

    During the cataract assessment clinic

Interventions

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

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Patients referred for cataract surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brighton & Sussex University Hospitals NHS Trust

Brighton, Sussex, BN2 5BF, United Kingdom

Location

MeSH Terms

Conditions

Retinal PerforationsEpiretinal MembraneMacular DegenerationCataract

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesRetinal DegenerationLens Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

November 2, 2020

Primary Completion

November 6, 2020

Study Completion

November 30, 2020

Last Updated

November 3, 2023

Record last verified: 2023-11

Locations