- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04887909
Prediction of Postoperative Visual Acuity in Cataract Patients Using a Macular Optical Coherence Tomography-based Deep Learning Method
May 13, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Anticipated)
1100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wen Xu
- Phone Number: +86-13858185223
- Email: xuwen2003@zju.edu.cn
Study Locations
-
-
-
Hangzhou, China
- Second Affiliated Hospital, Zhejiang University School of Medicine
-
Contact:
- Wen Xu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Description
Inclusion Criteria:
- Senile cataract patients, with or without macular disease, the impact of cataract on vision has affected the daily life of patients.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Best Corrected Visual Acuity
Time Frame: 1 month postoperatively
|
The BCVA was measured by the same optometrist at each visit
|
1 month postoperatively
|
|
Uncorrected distance visual acuity
Time Frame: 1 month postoperatively
|
The UCVA was measured by the same optometrist at each visit
|
1 month postoperatively
|
|
Macular optical coherence tomography
Time Frame: 1 month postoperatively
|
Macular oct was measured by the same doctor at each visit
|
1 month postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 20, 2021
Primary Completion (Anticipated)
December 31, 2026
Study Completion (Anticipated)
December 31, 2026
Study Registration Dates
First Submitted
May 13, 2021
First Submitted That Met QC Criteria
May 13, 2021
First Posted (Actual)
May 14, 2021
Study Record Updates
Last Update Posted (Actual)
May 14, 2021
Last Update Submitted That Met QC Criteria
May 13, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0496
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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