CataractNCT05491798
A Big Data-based Cohort Study for Cataract Patients
An observational study of Cataract and Retina Disorder, run by Sun Yat-sen University at 1 site in China.
Trial summary
Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Retina Disorder
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to Jun 2025
- How long will I take part?
- 1 Week
- 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: All candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.
Who may be able to join
- Candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.
Who cannot join
- Unwilling or unable to receive fundus photography
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D, 8613802793086, haot.lin@hotmail.com
Lixue Liu, M.D, +86-15602382879, liulx37@mail2.sysu.edu.cn
About this study
Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Previous studies have found that the surgical complications and postoperative visual function of cataract patients are closely related to the condition of the fundus, but the current fundus camera cannot perform clear fundus imaging of cataract patients, and the existing potential visual inspections, such as retinal visual inspection, are also inaccurate. Predict postoperative visual acuity. Therefore, there is an urgent need for a reliable postoperative effect prediction system for cataract patients to provide reference for both ophthalmologists and patients.
This study intends to collect patient medical record information and traditional/ultra-wide fundus photos and other multi-modal data. Firstly, this study will use artificial intelligence technology to enhance fundus photos of cataract patients to obtain clearer fundus photos. Then this study will use both medical record information and traditional/ultra-wide fundus photographs to predict postoperative vision and visual function of cataract patients.
- Conditions
- Cataract, Retina Disorder
- Keywords
- Cataract, Postoperative prediction, Image enhancement, Retina disorder
- Medical subject headings
- Cataract, Retinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of best corrected visual acuity
Change of best corrected visual acuity from baseline to 1 week after surgery
Measured: Baseline and 1 week after surgery
Accuracy for detection of retinal disorders
Accuracy for detection of retinal disorders using enhanced fundus images
Measured: 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jul 2020
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
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 CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D., Ph.D., Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491798
- Sponsor's protocol ID
- CCPMOH2021-China-1
- Status last verified
- Jan 2024
- First submitted
- 7 Aug 2021
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu L, Hong J, Wu Y, Liu S, Wang K, Li M, Zhao L, Liu Z, Li L, Cui T, Tsui CK, Xu F, Hu W, Yun D, Chen X, Shang Y, Bi S, Wei X, Lai Y, Lin D, Fu Z, Deng Y, Cai K, Xie Y, Cao Z, Wang D, Zhang X, Dongye M, Lin H, Wu X. Digital ray: enhancing cataractous fundus images using style transfer generative adversarial networks to improve retinopathy detection. Br J Ophthalmol. 2024 Sep 20;108(10):1423-1429. doi: 10.1136/bjo-2024-325403.
PubMed 38839251
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Big Data-based Cohort Study for Cataract Patients
- ClinicalTrials.gov ID
- NCT05491798
- Acronym / sponsor ID
- CCPMOH2021-China-1
- Conditions
- Cataract, Retina Disorder
- Keywords
- Cataract, Postoperative prediction, Image enhancement, Retina disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 8 Aug 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.
Cataract is an important cause of blindness and visual impairment worldwide. At present, the only effective treatment method is surgery. The visual function of most patients can be significantly improved after surgery, but there are still 5-20% of patients whose visual function cannot be improved after surgery. Previous studies have found that the surgical complications and postoperative visual function of cataract patients are closely related to the condition of the fundus, but the current fundus camera cannot perform clear fundus imaging of cataract patients, and the existing potential visual inspections, such as retinal visual inspection, are also inaccurate. Predict postoperative visual acuity. Therefore, there is an urgent need for a reliable postoperative effect prediction system for cataract patients to provide reference for both ophthalmologists and patients.
This study intends to collect patient medical record information and traditional/ultra-wide fundus photos and other multi-modal data. Firstly, this study will use artificial intelligence technology to enhance fundus photos of cataract patients to obtain clearer fundus photos. Then this study will use both medical record information and traditional/ultra-wide fundus photographs to predict postoperative vision and visual function of cataract patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.
Key inclusion criteria (1 listed)
- Candidates for cataract surgery (phacoemulsification and intraocular lens implantation) within a week.
Key exclusion criteria (1 listed)
- Unwilling or unable to receive fundus photography
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
Change of best corrected visual acuity
Time frame: Baseline and 1 week after surgery
Change of best corrected visual acuity from baseline to 1 week after surgery
Accuracy for detection of retinal disorders
Time frame: 1 week after surgery
Accuracy for detection of retinal disorders using enhanced fundus images
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 38839251Liu L, Hong J, Wu Y, Liu S, Wang K, Li M, Zhao L, Liu Z, Li L, Cui T, Tsui CK, Xu F, Hu W, Yun D, Chen X, Shang Y, Bi S, Wei X, Lai Y, Lin D, Fu Z, Deng Y, Cai K, Xie Y, Cao Z, Wang D, Zhang X, Dongye M, Lin H, Wu X. Digital ray: enhancing cataractous fundus images using style transfer generative adversarial networks to improve retinopathy detection. Br J Ophthalmol. 2024 Sep 20;108(10):1423-1429. doi: 10.1136/bjo-2024-325403.
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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.
Haotian Lin, M.D., Ph.D. principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
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 and Retina Disorder, run by Sun Yat-sen University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haotian Lin, M.D., Ph.D. (8613802793086, linht5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of best corrected visual acuity (time frame: Baseline and 1 week after surgery). The study lists 2 primary outcomes in all. 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 NCT05491798, 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 5 Jan 2024.