NCT04757350

Brief 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 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 17, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 9, 2021

Last Update Submit

February 13, 2021

Conditions

Keywords

cataract

Outcome Measures

Primary Outcomes (4)

  • Change from visual acuity at 6 months

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

    6 months

  • Change from Objective Scatter Index at 6 months

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

    6 months

  • Change from Contrast Sensitivity at 6 months

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

    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.

    6 months

Study Arms (1)

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

Other: Observational research, not applicable

Interventions

Observational research, not applicable

cataract

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Union Hospital Eye Clinic

You may qualify if:

  • 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

You may not qualify if:

  • Obvious conjunctivitis;
  • Obvious corneal epithelial punctate staining, corneal epithelial shedding;
  • Keratitis;
  • Uveitis;
  • Corneal scar;
  • Severe vitreous opacity or hemorrhage;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • yukan huang, professor

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

yukan yu huang, professor

CONTACT

yuzhi li, student

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 17, 2021

Study Start

February 1, 2021

Primary Completion

January 1, 2022

Study Completion

June 1, 2022

Last Updated

February 17, 2021

Record last verified: 2021-02

Locations