Diabetes MellitusNCT02579837
CLEAR SIGHT: A Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
A study testing Optos 200Tx and Zeiss Cirrus in people with Diabetes Mellitus and Diabetic Retinopathy, run by Western University, Canada at 1 site in Canada.
Trial summary
Diabetic eye disease causes major vision loss in many Canadians and is costly. There are effective preventions and treatments for diabetic eye disease but they strongly depend upon regular screening in asymptomatic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Retinopathy
- What is being tested?
- Optos 200Tx and Zeiss Cirrus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 742 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Dec 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
- Known diagnosis of Type 1 diabetes for >/= 5 years or Type 2 diabetes of any duration
- At least 12 months since the last screening for diabetic eye disease by an eye care professional as this is based on patient self-report. Subsequent confirmation of the date of the last eye examination will be obtained via communication with the patient's eye care professional. Patients who indicate by self-report that it has been more than a year since screening, but in whom it is subsequently confirmed that their last screen occurred <12 months prior to entry, will be randomized but will not be included in the primary analysis comparing On-Site to Usual Screening.
- Provision of informed consent
Who cannot join
- Under active followup by an ophthalmologist for DM-related eye disease. Active followup requires that, at recruitment, the patient is scheduled for a future ophthalmologist appointment for any reason.
- Inability to provide informed consent.
- Any other condition or circumstance which in the judgment of the investigator makes it unlikely that the patient can adhere to the study protocol. This includes co-morbidities for which expected life-expectancy is less than a year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CLEAR SIGHT: A Randomized Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
Diabetic eye disease causes major vision loss in many Canadians and is costly. There are effective preventions and treatments for diabetic eye disease but they strongly depend upon regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA) guidelines recommend annual screening by eye care professionals, either in-person or through interpretation of dilated pupil retinal photographs.
Despite the benefits of screening, adherence to these guidelines is poor. Reasons include patient barriers, i.e. need for eye drops, time off work, wait times, and transportation issues. An option to minimize these barriers is to screen using a camera called non-mydriatic ultra-widefield (UWF) retinal imaging. This can be quickly done without eye drops on the same day as patients' regularly scheduled diabetes clinic visits.
In this study, the investigators will compare the UWF camera to the usual screening approach recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye screening to either be screened using the UWF camera on the day of their diabetes clinic visit or be screened by their usual eye care professional. The investigators' prediction is that same-day screening with UWF imaging will find more patients with diabetic eye disease who need treatment compared to usual screening.
Read the detailed description
In this study, the investigators are addressing a significant and expanding "care-gap" question for patients with diabetes who are at risk for diabetic retinopathy (DR). DR is a major cause of impaired health-related quality of life in Ontarians through visual loss including blindness. Because the prevalence of DM in Ontario is increasing, the number of Ontarians over age 40 years with sight-threatening DR has been projected to increase by ~ 60% by 2031. DR is also a major source of health care costs: in 2007 the estimated health care system expenditure for vision loss from DR in Canada was $205 million.
There are proven effective strategies to prevent and treat DR. These strategies strongly depend upon regular screening in asymptomatic patients. Thus, the 2013 CDA practice guidelines recommended annual eye screening by experienced eye care professionals either in-person or through interpretation of dilated pupil retinal photographs and yet, despite the benefit of screening, adherence to the CDA guidelines is poor. At least part of this is due to patient-centered barriers including the need for mydriasis, time off of work, wait times, and transportation issues. Recent studies indicate that non-mydriatic UWF retinal imaging minimizes these barriers and also accurately detects clinically important DR as compared to reference standard tests (dilated pupil eye exam by an eye care professional or 7-field stereoscopic colour fundus photography).
In this study, the investigators' primary goal is to confirm or refute the hypothesis that screening by non-mydriatic UWF imaging at the time diabetes patients are seen for their routinely scheduled diabetes clinic visit (On-site Screening) improves the rate of detection of clinically important DR as compared to Usual Screening by the CDA guidelines. While the investigators are not testing the effect of screening by non-mydriatic UWF on visual outcomes, confirmation of the investigators' hypothesis has the potential to improve current screening strategies for DR in Ontario and, with that, an expectation that this will reduce vision-threatening diabetic eye disease.
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Being tested
- Optos 200Tx, Zeiss Cirrus
- Keywords
- screening
- Medical subject headings
- Diabetes Mellitus, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optos 200TxDevice
non-mydriatic ultra-widefield (UWF) retinal imaging device
Zeiss CirrusDevice
optical coherence tomographer (OCT)
| Study group | Role | What they receive |
|---|---|---|
| Usual Screening | No intervention | Participants randomized to the Usual Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care). |
| On-Site Screening | Experimental | Participants randomized to the On-Site Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care). However, they will also undergo non-mydriatic ultra-widefield (UWF) retinal imaging (both 100 and 200 degrees) using the Optos 200Tx UWF retinal imaging device in the Ophthalmology Department on the same day as their Diabetes Clinic visit.
Half of this group will by random allocation undergo optical coherence tomography (OCT) using the Zeiss Cirrus OCT, which may or may not be done on the same day (for practical reasons regarding availability of OCT at the hospital). Receives: Device: Optos 200Tx; Device: Zeiss Cirrus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with Actionable Eye Disease (AED)
Usual Screening Group: AED will be based upon DR grading and the disposition recommendation as that information is provided on the exam report from the participant's usual eye care professional. Any one of the following will be considered indicative of AED if noted on the report: a) moderate or severe non-proliferative DR; b) any proliferative DR; c) clinically significant macular edema (CSME); d) referral to an ophthalmologist; e) recommendation for re-examination in <12 months.
On-Site Screening Group: AED will be based on interpretation of non-mydriatic UWF images by a retinal specialist where AED will require at least 1 finding of: DR (intra-retinal microvascular abnormalities or venous beading >/= 2 quadrants, neovascularization elsewhere, neovascularization of the disc, vitreous hemorrhage) or diabetic maculopathy (microaneurysms, retinal hemorrhages or exudates within 1 disc diameter of the fovea)
Measured: within 12 months of randomization
Secondary outcomes (2)
Screening Adherence (rate of screening via primary assigned screening method)
Determined by (i) the proportions of participants who have screening completed within 12 months of randomization by the primary screening method, viz., non-mydriatic UWF images (On-site Screening group) or an eye examination by an eye care professional (Usual Screening group); (ii) for participants in the On-site Screening group, the proportion who have also had a screening eye examination by an eye care professional within 1 year of randomization. For (i) and (ii) above, documentation of a screening examination by an eye care professional will require that the exam findings be provided in a written report
Measured: within 12 months of randomization
Proportion of participants with Diabetic Maculopathy (DME)
Defined by: (i) the proportions of participants with clinically important macular edema detected by the primary screening method viz., non-mydriatic UWF images (On-site Screening group) or an eye examination by an eye care professional (Usual Screening group); (ii) the proportions of participants with DME detected by non-mydriatic UWF imaging alone versus non-mydriatic UWF imaging plus OCT; (iii) the proportions of participants with DME detected by non-mydriatic UWF imaging plus OCT versus eye examination by an eye care professional. The criteria to define DME by OCT are the presence of 1 or more of: intraretinal cysts, intraretinal exudates or subretinal fluid
Measured: within 12 months of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Selina Liu, Western University, Canada
- Investigators
- Selina L Liu, MD MSc FRCPC, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579837
- Sponsor's protocol ID
- 106583
- Status last verified
- Mar 2021
- First submitted
- 16 Oct 2015
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Liu SL, Mahon LW, Klar NS, Schulz DC, Gonder JR, Hramiak IM, Mahon JL. A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial. BMJ Open. 2017 Aug 3;7(8):e015382. doi: 10.1136/bmjopen-2016-015382.
PubMed 28775182
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLEAR SIGHT: A Randomized Trial of Non-Mydriatic Ultra-Widefield Retinal Imaging to Screen for Diabetic Eye Disease
- ClinicalTrials.gov ID
- NCT02579837
- Acronym / sponsor ID
- 106583
- Conditions
- Diabetes Mellitus, Diabetic Retinopathy
- Keywords
- screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 742 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Mar 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 20 Oct 2015 (estimated)
- 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.
Diabetic eye disease causes major vision loss in many Canadians and is costly. There are effective preventions and treatments for diabetic eye disease but they strongly depend upon regular screening in asymptomatic patients. The 2013 Canadian Diabetes Association (CDA) guidelines recommend annual screening by eye care professionals, either in-person or through interpretation of dilated pupil retinal photographs.
Despite the benefits of screening, adherence to these guidelines is poor. Reasons include patient barriers, i.e. need for eye drops, time off work, wait times, and transportation issues. An option to minimize these barriers is to screen using a camera called non-mydriatic ultra-widefield (UWF) retinal imaging. This can be quickly done without eye drops on the same day as patients' regularly scheduled diabetes clinic visits.
In this study, the investigators will compare the UWF camera to the usual screening approach recommended by the CDA. The investigators will invite 740 patients with diabetes due for eye screening to either be screened using the UWF camera on the day of their diabetes clinic visit or be screened by their usual eye care professional. The investigators' prediction is that same-day screening with UWF imaging will find more patients with diabetic eye disease who need treatment compared to usual screening.
Detailed description
In this study, the investigators are addressing a significant and expanding "care-gap" question for patients with diabetes who are at risk for diabetic retinopathy (DR). DR is a major cause of impaired health-related quality of life in Ontarians through visual loss including blindness. Because the prevalence of DM in Ontario is increasing, the number of Ontarians over age 40 years with sight-threatening DR has been projected to increase by ~ 60% by 2031. DR is also a major source of health care costs: in 2007 the estimated health care system expenditure for vision loss from DR in Canada was $205 million.
There are proven effective strategies to prevent and treat DR. These strategies strongly depend upon regular screening in asymptomatic patients. Thus, the 2013 CDA practice guidelines recommended annual eye screening by experienced eye care professionals either in-person or through interpretation of dilated pupil retinal photographs and yet, despite the benefit of screening, adherence to the CDA guidelines is poor. At least part of this is due to patient-centered barriers including the need for mydriasis, time off of work, wait times, and transportation issues. Recent studies indicate that non-mydriatic UWF retinal imaging minimizes these barriers and also accurately detects clinically important DR as compared to reference standard tests (dilated pupil eye exam by an eye care professional or 7-field stereoscopic colour fundus photography).
In this study, the investigators' primary goal is to confirm or refute the hypothesis that screening by non-mydriatic UWF imaging at the time diabetes patients are seen for their routinely scheduled diabetes clinic visit (On-site Screening) improves the rate of detection of clinically important DR as compared to Usual Screening by the CDA guidelines. While the investigators are not testing the effect of screening by non-mydriatic UWF on visual outcomes, confirmation of the investigators' hypothesis has the potential to improve current screening strategies for DR in Ontario and, with that, an expectation that this will reduce vision-threatening diabetic eye disease.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Screening | No intervention | –Participants randomized to the Usual Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care). |
| On-Site Screening | Experimental | Device: Optos 200Tx, Device: Zeiss CirrusParticipants randomized to the On-Site Screening group will be advised by their Endocrinologist during their Diabetes Clinic visit to arrange an eye examination with their usual eye care professional (as per current standard of care). However, they will also undergo non-mydriatic ultra-widefield (UWF) retinal imaging (both 100 and 200 degrees) using the Optos 200Tx UWF retinal imaging device in the Ophthalmology Department on the same day as their Diabetes Clinic visit. Half of this group will by random allocation undergo optical coherence tomography (OCT) using the Zeiss Cirrus OCT, which may or may not be done on the same day (for practical reasons regarding availability of OCT at the hospital). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Known diagnosis of Type 1 diabetes for >/= 5 years or Type 2 diabetes of any duration
- At least 12 months since the last screening for diabetic eye disease by an eye care professional as this is based on patient self-report. Subsequent confirmation of the date of the last eye examination will be obtained via communication with the patient's eye care professional. Patients who indicate by self-report that it has been more than a year since screening, but in whom it is subsequently confirmed that their last screen occurred <12 months prior to entry, will be randomized but will not be included in the primary analysis comparing On-Site to Usual Screening.
- Provision of informed consent
Key exclusion criteria (3 listed)
- Under active followup by an ophthalmologist for DM-related eye disease. Active followup requires that, at recruitment, the patient is scheduled for a future ophthalmologist appointment for any reason.
- Inability to provide informed consent.
- Any other condition or circumstance which in the judgment of the investigator makes it unlikely that the patient can adhere to the study protocol. This includes co-morbidities for which expected life-expectancy is less than a year.
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 |
|---|---|---|
| Optos 200Txnon-mydriatic ultra-widefield (UWF) retinal imaging device | Device | On-Site Screening |
| Zeiss Cirrusoptical coherence tomographer (OCT) | Device | On-Site Screening |
Primary outcome
Proportion of participants with Actionable Eye Disease (AED)
Time frame: within 12 months of randomization
Usual Screening Group: AED will be based upon DR grading and the disposition recommendation as that information is provided on the exam report from the participant's usual eye care professional. Any one of the following will be considered indicative of AED if noted on the report: a) moderate or severe non-proliferative DR; b) any proliferative DR; c) clinically significant macular edema (CSME); d) referral to an ophthalmologist; e) recommendation for re-examination in <12 months. On-Site Screening Group: AED will be based on interpretation of non-mydriatic UWF images by a retinal specialist where AED will require at least 1 finding of: DR (intra-retinal microvascular abnormalities or venous beading >/= 2 quadrants, neovascularization elsewhere, neovascularization of the disc, vitreous hemorrhage) or diabetic maculopathy (microaneurysms, retinal hemorrhages or exudates within 1 disc diameter of the fovea)
2 secondary outcomes
Screening Adherence (rate of screening via primary assigned screening method)
Time frame: within 12 months of randomization
Proportion of participants with Diabetic Maculopathy (DME)
Time frame: within 12 months of randomization
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 23 Mar 2021.
- Background: PubMed 28775182Liu SL, Mahon LW, Klar NS, Schulz DC, Gonder JR, Hramiak IM, Mahon JL. A randomised trial of non-mydriatic ultra-wide field retinal imaging versus usual care to screen for diabetic eye disease: rationale and protocol for the Clearsight trial. BMJ Open. 2017 Aug 3;7(8):e015382. doi: 10.1136/bmjopen-2016-015382.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Selina L Liu, MD MSc FRCPC principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optos 200Tx and Zeiss Cirrus in people with Diabetes Mellitus and Diabetic Retinopathy, run by Western University, Canada at 1 site in Canada.
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 3 inclusion and 3 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 23 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 Canada. 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?
Proportion of participants with Actionable Eye Disease (AED) (time frame: within 12 months of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579837, which also lists 1 linked publication.
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 23 Mar 2021.