Data CollectingNCT04887909
Prediction of Postoperative Visual Acuity in Cataract Patients Using a Macular Optical Coherence Tomography-based Deep Learning Method
An observational study of Data Collecting, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to collect the macular OCT images and preoperative and postoperative visual acuity of cataract patients who had been operated in the eye center of the Second Affiliated Hospital of Zhejiang University Medical College, and to train a model that can relatively accurately predict the… Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Data Collecting
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Who may be able to join
- Senile cataract patients, with or without macular disease, the impact of cataract on vision has affected the daily life of patients.
Who cannot join
- Glasses can obviously improve eyesight
- In addition to macular disease, combined with other eye diseases that seriously affect vision, resulting in no significant improvement in postoperative vision
- Complicated cataract surgery due to trauma and other reasons
- Combined with other eye diseases not suitable for intraocular lens implantation
- Patients with systemic diseases who cannot tolerate surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Wen Xu
About this study
The purpose of this study is to collect the macular OCT images and preoperative and postoperative visual acuity of cataract patients who had been operated in the eye center of the Second Affiliated Hospital of Zhejiang University Medical College, and to train a model that can relatively accurately predict the postoperative visual acuity of patients by deep learing.
- Conditions
- Data Collecting
- Keywords
- artificial intelligence, deep learning, cataract surgery, acuity vision, macular, optical coherence tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected distance visual acuity
The UCVA was measured by the same optometrist at each visit
Measured: 1 month postoperatively
Best Corrected Visual Acuity
The BCVA was measured by the same optometrist at each visit
Measured: 1 month postoperatively
Macular optical coherence tomography
Macular oct was measured by the same doctor at each visit
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start20 May 2021 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Data CollectingStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887909
- Sponsor's protocol ID
- 2021-0496
- Status last verified
- May 2021
- First submitted
- 13 May 2021
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Postoperative Visual Acuity in Cataract Patients Using a Macular Optical Coherence Tomography-based Deep Learning Method
- ClinicalTrials.gov ID
- NCT04887909
- Acronym / sponsor ID
- 2021-0496
- Conditions
- Data Collecting
- Keywords
- artificial intelligence, deep learning, cataract surgery, acuity vision, macular, optical coherence tomography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 May 2021 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 May 2021 (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 this study is to collect the macular OCT images and preoperative and postoperative visual acuity of cataract patients who had been operated in the eye center of the Second Affiliated Hospital of Zhejiang University Medical College, and to train a model that can relatively accurately predict the postoperative visual acuity of patients by deep learing.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Key inclusion criteria (1 listed)
- Senile cataract patients, with or without macular disease, the impact of cataract on vision has affected the daily life of patients.
Key exclusion criteria (5 listed)
- Glasses can obviously improve eyesight
- In addition to macular disease, combined with other eye diseases that seriously affect vision, resulting in no significant improvement in postoperative vision
- Complicated cataract surgery due to trauma and other reasons
- Combined with other eye diseases not suitable for intraocular lens implantation
- Patients with systemic diseases who cannot tolerate surgery
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
Uncorrected distance visual acuity
Time frame: 1 month postoperatively
The UCVA was measured by the same optometrist at each visit
Best Corrected Visual Acuity
Time frame: 1 month postoperatively
The BCVA was measured by the same optometrist at each visit
Macular optical coherence tomography
Time frame: 1 month postoperatively
Macular oct was measured by the same doctor at each visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
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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.
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 Data Collecting, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 5 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: opening soon, as of the sponsor's last update on 14 May 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu (+86-13858185223, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected distance visual acuity (time frame: 1 month postoperatively). The study lists 3 primary outcomes in all. 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 14 May 2021.