CataractNCT04757350
Objective Visual Quality Analysis System is Used in Cataract
An observational study of Cataract, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Observational research, not applicable
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 1 Jun 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Union Hospital Eye Clinic
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Union Hospital
Wuhan, Hubei, 430000
yukan huang, professor, 8618908626864, huangyk1975@163.com
yuzhi li, student, 8613886796468, 616431642@qq.com
About this study
Official title: 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
Read the 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.
- Conditions
- Cataract
- Being tested
- Observational research, not applicable
- Keywords
- cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational research, not applicableOther
Observational research, not applicable
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Observational research, not applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from visual acuity at 6 months
VA after cataract surgery 1 week、1month、3month、6month
Measured: 6 months
Change from Objective Scatter Index at 6 months
OSI after cataract surgery 1 week、1month、3month、6month
Measured: 6 months
Change from Contrast Sensitivity at 6 months
CS after cataract surgery 1 week、1month、3month、6month
Measured: 6 months
Change from Patient Satisfaction Scale at 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start1 Feb 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yukan Huang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Investigators
- yukan huang, professor, Study chair, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757350
- Sponsor's protocol ID
- YKHYK2020
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Visual Quality Analysis System is Used to Evaluate the Effect of Cataract Surgery and Manage Postoperative Complications
- ClinicalTrials.gov ID
- NCT04757350
- Acronym / sponsor ID
- YKHYK2020
- Conditions
- Cataract
- Keywords
- cataract
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 17 Feb 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 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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cataract | – | Other: Observational research, not applicableResearch 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Union Hospital Eye Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- Obvious conjunctivitis;
- Obvious corneal epithelial punctate staining, corneal epithelial shedding;
- Keratitis;
- Uveitis;
- Corneal scar;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational research, not applicableObservational research, not applicable | Other | cataract |
Primary outcome
Change from visual acuity at 6 months
Time frame: 6 months
VA after cataract surgery 1 week、1month、3month、6month
Change from Objective Scatter Index at 6 months
Time frame: 6 months
OSI after cataract surgery 1 week、1month、3month、6month
Change from Contrast Sensitivity at 6 months
Time frame: 6 months
CS after cataract surgery 1 week、1month、3month、6month
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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. This study is not recruiting at the moment.
yukan huang, professor study chair
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 3 inclusion and 7 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 17 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yukan yu huang, professor (8618908626863, huangyk1975@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from visual acuity at 6 months (time frame: 6 months). The study lists 4 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 17 Feb 2021.