CataractCATNCT03531671
Assessing the Optics of the Eye Pre- and Post-operatively in Cataract
A study testing Binocular-OCT in people with Cataract, run by Moorfields Eye Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Binocular-OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2018to 17 Nov 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Presence of cataract
- Male or female, aged 18 years or older
- Ability to understand nature/purpose of the study and to provide informed consent
- Ability to undergo binocular OCT imaging
- Ability to follow instructions and complete the study
- Ability to speak English
Who cannot join
- - Hearing impairment sufficient to interfere with hearing instructions
- Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
- Any cases where the globe has been affected by trauma, etc.
- Traumatic aetiologies of cataract
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
Official title: The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application
The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract.
Read the detailed description
Cataract is the second leading cause of blindness in western Europe but the leading cause of blindness in the developing world and both central and eastern Europe. The most common cause of cataract is age. A number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. Currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. Such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. A novel instrument that offers a solution to such problems is the recently developed Binocular Optical Coherence Tomographer. Binocular-OCT is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. The Binocular-OCT has the capability to perform the functions of many clinical tools in a single instrument. Of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source OCT technology. In this study, the proposed advantages of binocular OCT system will be assessed for the management of cataract.
This research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.
- Conditions
- Cataract
- Being tested
- Binocular-OCT
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binocular-OCTDevice
Binocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant.
| Study group | Role | What they receive |
|---|---|---|
| Presence of age related cataract | Experimental | Binocular-OCT used to assess the eye pre and post-operatively. Receives: Device: Binocular-OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Investigate the feasibility of the Binocular-OCT to produce accurate biometric measurements of the eye, via calculation of quantitative cataract density and localisation index from the binocular-OCT image of the lens.
Measured: 18 Months
Secondary outcomes (3)
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the lens position.
Measured: 18 Months
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the ocular clarity.
Measured: 18 Months
Post-Operative Measurements
Examining the ability of the Binocular-OCT to perform post-operative assessments of the retinal thickness.
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start30 Aug 2018
- Primary completion25 Feb 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Assessing age related cataract, all 200 subjects will have whole eye OCT scan performed during their pre-operative cataract assessment and 50 subjects (all subjects requested to participate until 50 subject criteria met) will have these assessments reassessed during their post-operative assessment.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pearse Keane, Study director, Moorfields Eye Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531671
- Sponsor's protocol ID
- KEAP1003
- Acronym
- CAT
- Status last verified
- Feb 2021
- First submitted
- 13 Mar 2018
- Last updated
- 1 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data retained within the central research team.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Future of Cataract Assessment: Investigation of the Utility of a Novel Binocular OCT System for Clinical Application
- ClinicalTrials.gov ID
- NCT03531671
- Acronym / sponsor ID
- CAT / KEAP1003
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Moorfields Eye Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 22 May 2018 (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.
The purpose of the study is to investigate if a novel instrument called a Binocular Optical Coherence Tomographer (OCT) may resolve many of the issues with the assessment of patients with cataract.
Detailed description
Cataract is the second leading cause of blindness in western Europe but the leading cause of blindness in the developing world and both central and eastern Europe. The most common cause of cataract is age. A number of clinical assessments are required to assess the status and suitability of each patient for cataract surgery. Currently, these procedures are performed in an inefficient manner with the patient having to move to different clinical areas to access often large instruments that are costly to both purchase and maintain. Such an inefficient patient pathway has been identified as a factor that can markedly increase the cost of outpatient appointments, extend waiting times, and crucially lead to a reduction in patient satisfaction. A novel instrument that offers a solution to such problems is the recently developed Binocular Optical Coherence Tomographer. Binocular-OCT is capable of non-invasively imaging the whole-eye in a potentially small, inexpensive and portable device and is also capable of capturing images from both eyes in the same session without the need for assistance from a trained technician. The Binocular-OCT has the capability to perform the functions of many clinical tools in a single instrument. Of particular relevance to the assessment of the patient with cataract is the ability to capture high resolution images of the anterior eye and crystalline lens with swept-source OCT technology. In this study, the proposed advantages of binocular OCT system will be assessed for the management of cataract.
This research is important, to not only improve cataract assessment and optomise surgical outcomes, but it is also vital to establish sensitive measures of lens quality to determine tools to aid trails attempting to retard the progression of cataract.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Assessing age related cataract, all 200 subjects will have whole eye OCT scan performed during their pre-operative cataract assessment and 50 subjects (all subjects requested to participate until 50 subject criteria met) will have these assessments reassessed during their post-operative assessment.
| Arm | Type | Receives |
|---|---|---|
| Presence of age related cataract | Experimental | Device: Binocular-OCTBinocular-OCT used to assess the eye pre and post-operatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - Presence of cataract
- Male or female, aged 18 years or older
- Ability to understand nature/purpose of the study and to provide informed consent
- Ability to undergo binocular OCT imaging
- Ability to follow instructions and complete the study
Key exclusion criteria (4 listed)
- - Hearing impairment sufficient to interfere with hearing instructions
- Any condition which, in the investigator's opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule, or other study conduct.
- Any cases where the globe has been affected by trauma, etc.
- Traumatic aetiologies of cataract
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 |
|---|---|---|
| Binocular-OCTBinocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant. | Device | Presence of age related cataract |
Primary outcome
Feasibility
Time frame: 18 Months
Investigate the feasibility of the Binocular-OCT to produce accurate biometric measurements of the eye, via calculation of quantitative cataract density and localisation index from the binocular-OCT image of the lens.
3 secondary outcomes
Post-Operative Measurements
Time frame: 18 Months
Post-Operative Measurements
Time frame: 18 Months
Post-Operative Measurements
Time frame: 18 Months
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 1 Mar 2021.
- Individual participant dataSharing planned: No. Data retained within the central research team.
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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.
Pearse Keane study director
Moorfields Eye Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binocular-OCT in people with Cataract, run by Moorfields Eye Hospital NHS Foundation 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 6 inclusion and 4 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 1 Mar 2021. 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?
Feasibility (time frame: 18 Months). 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 1 Mar 2021.