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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

yukan yu huang, professor contact

8618908626863

huangyk1975@163.com

yuzhi li, student contact

8613886796468

616431642@qq.com

China1 site, 1 recruiting
  • Union Hospital

    Wuhan, Hubei, 430000

    yukan huang, professor, 8618908626864, huangyk1975@163.com

    yuzhi li, student, 8613886796468, 616431642@qq.com

    Recruiting

Other trials in China

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 groups in NCT04757350
Study groupRoleWhat they receive
cataractResearch 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.

  1. Change from visual acuity at 6 months

    VA after cataract surgery 1 week、1month、3month、6month

    Measured: 6 months

  2. Change from Objective Scatter Index at 6 months

    OSI after cataract surgery 1 week、1month、3month、6month

    Measured: 6 months

  3. Change from Contrast Sensitivity at 6 months

    CS after cataract surgery 1 week、1month、3month、6month

    Measured: 6 months

  4. 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.

  1. First posted17 Feb 2021
  2. Study start1 Feb 2021
  3. Primary completion1 Jan 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Resources

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)
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

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.

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