- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04757350
Objective Visual Quality Analysis System is Used in Cataract
February 13, 2021 updated by: Yukan Huang, Wuhan Union Hospital, China
Objective Visual Quality Analysis System is Used to Evaluate the Effect of Cataract Surgery and Manage Postoperative Complications
The Objective Visual Quality Analysis System (OQAS) is a new inspection technology used to objectively assess the visual quality of the human eye.
The investigators use this advanced technology to evaluate and follow up cataract patients before and after surgery, and observe the incidence, severity, and treatment effects of postoperative complications such as postoperative complications, and analyze the severity and artificial The influence of lens type, postoperative time, systemic diseases and other factors on the effect of cataract surgery, in order to discover the key factors that affect the effect of cataract surgery and the management of complications, and provide a useful reference for improving the level of cataract prevention and treatment in China
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The Objective Visual Quality Analysis System (OQAS) is a new inspection technology used to objectively assess the visual quality of the human eye.
It can detect the impact of ocular refractive system diseases on the objective visual quality of patients.
It is currently mainly used to assess the progress of cataracts and help selection the timing of surgery has achieved good clinical results.
Before the emergence of OQAS, the rating of cataracts largely relied on the subjective experience of physicians, and OQAS could accurately assess the effects of cataracts on the visual quality of the human eye by quantitatively detecting the light scattering index (OSI) of the refractive medium of the human eye.
The impact provides a quantitative evaluation basis for the diagnosis and treatment of cataract and research.
However, the application of OQAS in cataract surgery effect evaluation and postoperative complications management is still lacking.
After cataract surgery, although the cloudy lens nucleus and cortex have been removed, the original refractive error, vitreous opacity, postoperative posterior capsule folds, posterior dysfunction and many other factors may still affect the objective of the human eye visual quality, and ordinary visual inspection is difficult to find this effect .
In addition, preoperative OSI and other indicators of cataract, as an exposure factor, may affect the incidence of postoperative complications, such as after-cataract, macular edema, etc.
It is worthy of further study.
The application of OQAS can accurately assess the improvement of objective visual quality after cataract surgery, and find and remove other factors that affect OSI.
In addition, for one of the most common complications after cataract surgery-after-onset disorder, there is no uniform rating standard in the academic circles, and OQAS can provide objective data for the rating of after-onset disorder, so as to provide information on the postoperative complications such as late-onset disorder.
Provide reference for the management of .
The research team intends to use OQAS to evaluate and follow up cataract patients before and after surgery, and observe the incidence, severity, and treatment effects of postoperative complications such as after-cataract, analyze the severity of cataract or after-cataract, and intraocular lens The influence of factors such as type, postoperative time, systemic disease on the effect of cataract surgery.
We will also rate the posterior disorder based on OSI, and examine the effects and risks of different grades of posterior disorder after laser capsulotomy and other treatments, in order to use OQAS to better guide cataract surgery and postoperative complications management.
Study Type
Observational
Enrollment (Anticipated)
100
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: yukan yu huang, professor
- Phone Number: 8618908626863
- Email: huangyk1975@163.com
Study Contact Backup
- Name: yuzhi li, student
- Phone Number: 8613886796468
- Email: 616431642@qq.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Union Hospital
-
Contact:
- yuzhi li, student
- Phone Number: 8613886796468
- Email: 616431642@qq.com
-
Contact:
- yukan huang, professor
- Phone Number: 8618908626864
- Email: huangyk1975@163.com
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Union Hospital Eye Clinic
Description
Inclusion Criteria:
- Cataract patients aged 18-90 or patients after cataract surgery;
- Signed and dated informed consent;
- Commit to abide by the research procedures and cooperate with the implementation of the whole process research
Exclusion Criteria:
- Obvious conjunctivitis;
- Obvious corneal epithelial punctate staining, corneal epithelial shedding;
- Keratitis;
- Uveitis;
- Corneal scar;
- Severe vitreous opacity or hemorrhage;
- Other situations deemed unsuitable for inclusion in this study after evaluation by ophthalmologists.
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: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
cataract
Research subjects should meet the following criteria: Signed and dated informed consent form Commitment to abide by the research procedures and cooperate with the implementation of the whole process of research 18-90-year-old cataract patients or patients after cataract surgery
|
Observational research, not applicable
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from visual acuity at 6 months
Time Frame: 6 months
|
VA after cataract surgery 1 week、1month、3month、6month
|
6 months
|
Change from Objective Scatter Index at 6 months
Time Frame: 6 months
|
OSI after cataract surgery 1 week、1month、3month、6month
|
6 months
|
Change from Contrast Sensitivity at 6 months
Time Frame: 6 months
|
CS after cataract surgery 1 week、1month、3month、6month
|
6 months
|
Change from Patient Satisfaction Scale at 6 months
Time Frame: 6 months
|
Patient Satisfaction Scale after cataract surgery 1 week、1month、3month、6month.The minimum values is 0 and maximum values is 100.100 points mean the best outcome.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: yukan huang, professor, Wuhan Union Hospital, China
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 (Actual)
February 1, 2021
Primary Completion (Anticipated)
January 1, 2022
Study Completion (Anticipated)
June 1, 2022
Study Registration Dates
First Submitted
February 9, 2021
First Submitted That Met QC Criteria
February 13, 2021
First Posted (Actual)
February 17, 2021
Study Record Updates
Last Update Posted (Actual)
February 17, 2021
Last Update Submitted That Met QC Criteria
February 13, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YKHYK2020
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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