Cataract SenileNCT05287269
Ocular Coherence Tomography During Cataract Assessment
An observational study of Cataract Senile and Macula Hole, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages Up to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract Senile, Macula Hole, Epiretinal Membrane
- What is being tested?
- Ocular Coherence Tomography
- How many people
- 626 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2020to 30 Nov 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Patients referred for cataract surgery
Who cannot join
- Patients unable to attend the cataract assessment clinic
- Morbid patients who cannot be assessed on OCT or slit lamp
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brighton & Sussex University Hospitals NHS Trust
Brighton, Sussex, BN2 5BF
About this study
Official title: 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.
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.
- Conditions
- Cataract Senile, Macula Hole, Epiretinal Membrane, Age Related Macular Degeneration, Vitreomacular Traction
- Being tested
- Ocular Coherence Tomography
- Keywords
- cataract, macular pathology, ocular coherence tomography
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane, Macular Degeneration, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular Coherence TomographyDiagnostic test
Also called Swept Source 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: During the cataract assessment clinic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start2 Nov 2020
- Primary completion6 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Brighton and Sussex University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287269
- Sponsor's protocol ID
- 2112020
- Status last verified
- Nov 2023
- First submitted
- 10 Mar 2022
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of Ocular Coherence Tomography During Cataract Assessment
- ClinicalTrials.gov ID
- NCT05287269
- Acronym / sponsor ID
- 2112020
- Conditions
- Cataract Senile, Macula Hole, Epiretinal Membrane, Age Related Macular Degeneration, Vitreomacular Traction
- Keywords
- cataract, macular pathology, ocular coherence tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Brighton and Sussex University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients referred for cataract surgery
Key exclusion criteria (2 listed)
- Patients unable to attend the cataract assessment clinic
- Morbid patients who cannot be assessed on OCT or slit lamp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular Coherence TomographyAlso: Swept Source ocular coherence tomographyOCT 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). | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
Incidence of macular pathologies in the fellow eye
Time frame: During the cataract assessment clinic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract Senile and Macula Hole, run by Brighton and Sussex University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of occult macular pathologies in the eye referred for cataract surgery (time frame: During the cataract assessment clinic). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.