Retinal DiseasesNCT05836194
Evaluation of Diabetic Retinopathy Using Ultra-Widefield Fundus Images Compared With Two-Field Fundus Images
An observational study of Retinal Diseases and Diabetic Retinopathy, run by Ningbo Eye Hospital at 1 site in China.
Trial summary
This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Diseases, Diabetic Retinopathy, Diabetes Complications
- How many people
- 769 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients (18 and older) with diabetes presenting at the outpatient clinic of the Department of Ophthalmology, Ningbo Eye Hospital, practice for examination of diabetic retinopathy.
Who may be able to join
- Age 18 years or older.
- Diagnosis of diabetes mellitus.
Who cannot join
- Diseases involving the posterior pole other than DR, such as age-related macular degeneration，retinal vein occlusion.
- History of panretinal laser photocoagulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultra-Widefield Scanning Laser Ophthalmoscopy and Two-Field Fundus Photography for Evaluating Diabetic Retinopathy
This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.
Read the detailed description
As of 2030,9.7% (108.4 million) people in the China population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. Diabetic retinopathy (DR) and diabetic macular oedema (DME) are the principal causes of adult vision loss. Nevertheless,DR has few visual symptoms until DME occurs or the lessions located in the peripheral retina.Thus,it is crucial to early diagnosis and treatment of DR patients,which will prevent vision loss and reduce the societal buren of diabetes.
The Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30° color fundus photography is a time-consuming examination requiring pharmacological pupil dilation,experienced photographers and image montage.To simplify the operation process and improve patient compliance,2-field 45° retinal photographs (1 macular-centered field and 1 disc-centerde field) was proposed in the EURODIAB IDDM complications study and widely used in DR screening.Two-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from DR,while may be neglected DR pathology in the peripheral retina.With the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settings,espesially in predominantly peripheral lession(PPL).
Patients with DM, with or without known DR, will be imaged using the optomap and 2-field 45° retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital. Internal validation and continuous quality control will routinely be conducted. According to the International Clinical Diabetic Retinopathy Disease Severity Scale, the data for the ungradable image rate, distribution of DR severity levels, and PPL will be evaluated and compared. Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs.
- Conditions
- Retinal Diseases, Diabetic Retinopathy, Diabetes Complications, Diabetes Mellitus, Screening
- Keywords
- Diabetic Retinopathy, Ultra wide-field imaging, Fundus Photography, Screening
- Medical subject headings
- Retinal Diseases, Diabetic Retinopathy, Diabetes Complications, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison
To compare nonmydriatic 2-fields fundus photographs with nonmydriatic ultra-wide field images for determining diabetic retinopathy(DR) severity. DR severity level agreement will be cross-tabulated, and Kappa value will be calculated.
Measured: 60 days
Secondary outcomes (2)
Number of Ungradable Images within the 2-field fundus photography and Optomap imaging
The proportion and reasons of ungradable images will be documented.
Measured: 7 day
Number of predominantly peripheral lession(PPL) with Optomap imaging
The proportion of PPL images will be documented
Measured: 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Oct 2022
- Primary completion30 Sep 2023
- Study completion30 Jun 2024
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 Retinal DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 769 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaotian Liu, MD, Study director, Ningbo Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836194
- Sponsor's protocol ID
- DRUWFVSFP20230501
- Status last verified
- Aug 2024
- First submitted
- 18 Apr 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Y, Fu C, Xiu L, Zhang L, Zhang X, Chen C, Li Z. A prospective comparison of ultrawide-field and two-field fundus imaging for diabetic retinopathy assessment. BMC Med Imaging. 2026 Mar 6;26(1):187. doi: 10.1186/s12880-026-02260-z.
PubMed 41792656
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultra-Widefield Scanning Laser Ophthalmoscopy and Two-Field Fundus Photography for Evaluating Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05836194
- Acronym / sponsor ID
- DRUWFVSFP20230501
- Conditions
- Retinal Diseases, Diabetic Retinopathy, Diabetes Complications, Diabetes Mellitus, Screening
- Keywords
- Diabetic Retinopathy, Ultra wide-field imaging, Fundus Photography, Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 769 participants (actual)
- Lead sponsor
- Ningbo Eye HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 May 2023 (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.
This study aims to compare the accuracy of evaluating diabetic retinopathy using ultra-widefield fundus images versus two-field fundus images. The hypothesis is that screening and grading diabetic retinopathy based on ultra-widefield fundus images may yield higher accuracy compared to the use of two-field fundus images.
Detailed description
As of 2030,9.7% (108.4 million) people in the China population have diabetes, and the total costs of diabetes in adults would reach $460.4 billion. Diabetic retinopathy (DR) and diabetic macular oedema (DME) are the principal causes of adult vision loss. Nevertheless,DR has few visual symptoms until DME occurs or the lessions located in the peripheral retina.Thus,it is crucial to early diagnosis and treatment of DR patients,which will prevent vision loss and reduce the societal buren of diabetes.
The Early Treatment Diabetic Retinopathy Study (ETDRS) standard 7-field 30° color fundus photography is a time-consuming examination requiring pharmacological pupil dilation,experienced photographers and image montage.To simplify the operation process and improve patient compliance,2-field 45° retinal photographs (1 macular-centered field and 1 disc-centerde field) was proposed in the EURODIAB IDDM complications study and widely used in DR screening.Two-field 45° retinal photographs has been proven beneficial in reducing blindness resulting from DR,while may be neglected DR pathology in the peripheral retina.With the development of imaging technology, nonmydriatic ultra-widefield scanning laser opthoalmascopy (optomap) can obtain high-resolution,widefield images (180-200°) of the retina in only 0.25s. Optomap had good agreement with 7-field ETDRS in determining DR and DME severity and may be profitable in DR evaluation in research and clinical settings,espesially in predominantly peripheral lession(PPL).
Patients with DM, with or without known DR, will be imaged using the optomap and 2-field 45° retinal photographs imaging device both for diagnosis and screening purposes at Ningbo Eye Hospital. Internal validation and continuous quality control will routinely be conducted. According to the International Clinical Diabetic Retinopathy Disease Severity Scale, the data for the ungradable image rate, distribution of DR severity levels, and PPL will be evaluated and compared. Statistics analysis will explore the agreement of DR severity levels between optomap images and 2-field photographs.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients (18 and older) with diabetes presenting at the outpatient clinic of the Department of Ophthalmology, Ningbo Eye Hospital, practice for examination of diabetic retinopathy.
Key inclusion criteria (2 listed)
- Age 18 years or older.
- Diagnosis of diabetes mellitus.
Key exclusion criteria (2 listed)
- Diseases involving the posterior pole other than DR, such as age-related macular degeneration，retinal vein occlusion.
- History of panretinal laser photocoagulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison
Time frame: 60 days
To compare nonmydriatic 2-fields fundus photographs with nonmydriatic ultra-wide field images for determining diabetic retinopathy(DR) severity. DR severity level agreement will be cross-tabulated, and Kappa value will be calculated.
2 secondary outcomes
Number of Ungradable Images within the 2-field fundus photography and Optomap imaging
Time frame: 7 day
Number of predominantly peripheral lession(PPL) with Optomap imaging
Time frame: 7 day
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 22 Aug 2024.
- Derived from this study: PubMed 41792656Li Y, Fu C, Xiu L, Zhang L, Zhang X, Chen C, Li Z. A prospective comparison of ultrawide-field and two-field fundus imaging for diabetic retinopathy assessment. BMC Med Imaging. 2026 Mar 6;26(1):187. doi: 10.1186/s12880-026-02260-z.
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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.
Xiaotian Liu, MD study director
Ningbo Eye Hospital
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 Retinal Diseases and Diabetic Retinopathy, run by Ningbo Eye Hospital at 1 site in China.
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 2 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 22 Aug 2024. 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 China. 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?
The International Clinical Diabetic Retinopathy Disease Severity Scale within the 2-fields fundus photography and Ultra-Wide field scanning laser ophthalmoscopy (Optomap) imaging and statistical comparison (time frame: 60 days). 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 NCT05836194, 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 22 Aug 2024.