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Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients

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ClinicalTrials.gov Identifier: NCT04833491
Recruitment Status : Recruiting
First Posted : April 6, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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Brief Summary:
This study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intend to further improve the quality of Clinical Cataract diagnosis and treatment.

Condition or disease
Recruitment of Participants

Detailed Description:
Based on the existing cataract surgery methods, through prospective follow-up study, this study summarizes the experience of precision treatment and postoperative management of various types of cataract, and intends to further improve the quality of Clinical Cataract diagnosis and treatment.
Study Design
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study of the Correlation Between Preoperative Precise Biometrics, Spatial Assessment and Postoperative Visual Quality in Cataract Patients
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Groups and Cohorts
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Group/Cohort
Senile cataract
Traumatic cataract
Congenital cataract
Lens dislocation group
Complicated cataract


Outcome Measures
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Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: 1 week postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  2. Best Corrected Visual Acuity [ Time Frame: 1 month postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  3. Best Corrected Visual Acuity [ Time Frame: 3 months postoperatively ]
    The BCVA was measured by the same optometrist at each visit

  4. Uncorrected distance visual acuity [ Time Frame: 1 week postoperatively ]
    The UCVA was measured by the same optometrist at each visit

  5. Uncorrected distance visual acuity [ Time Frame: 1 month postoperatively ]
    The UCVA was measured by the same optometrist at each visit

  6. Uncorrected distance visual acuity [ Time Frame: 3 months postoperatively ]
    The UCVA was measured by the same optometrist at each visit

  7. Intraocular pressure [ Time Frame: 1 week postoperatively ]
    Intraocular pressure measured using non-contact tonometer

  8. Intraocular pressure [ Time Frame: 1 month postoperatively ]
    Intraocular pressure measured using non-contact tonometer

  9. Intraocular pressure [ Time Frame: 3 months postoperatively ]
    Intraocular pressure measured using non-contact tonometer

  10. Tear Breakup Time [ Time Frame: 1 week postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  11. Tear Breakup Time [ Time Frame: 1 month postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  12. Tear Breakup Time [ Time Frame: 3 months postoperatively ]
    Tear Breakup Time was performed to assess tear film stability

  13. Endothelial cell density [ Time Frame: 1 month postoperatively ]
    Endothelial cell density was measured by specular microscopy

  14. Contrast sensitivity [ Time Frame: 1 month postoperatively ]
    The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment

  15. Defocusing curve [ Time Frame: 1 month postoperatively ]
    From +2.00d to -4.00d, 13 different diopter states were obtained by decreasing the spherical lens degree of +0.50d, and the defocus curve was formed

  16. Stereoscopic vision [ Time Frame: 1 month postoperatively ]
    The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles

  17. Glasses usage frequency [ Time Frame: 3 months postoperatively ]
    The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%

  18. Optical visual quality questionnaire [ Time Frame: 3 months postoperatively ]
    Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)

  19. Visual satisfaction [ Time Frame: 3 months postoperatively ]
    The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University
Criteria

Inclusion Criteria:

  • Patients with monocular or binocular cataract, lens opacity or abnormal position, need surgery

Exclusion Criteria:

  • The history of systemic diseases and medication affecting vision, diabetic patients with systemic conditions complicated with retinopathy, uncontrolled blood glucose, severe eye diseases, eye trauma, eye surgery, severe dry eye and ocular surface diseases, strabismus and amblyopia were identified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833491


Contacts
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Contact: Wen Xu +86-13858185223 xuwen2003@zju.edu.cn

Locations
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China
Second Affiliated Hospital, Zhejiang University School of Medicine Recruiting
Hangzhou, China
Contact: Wen Xu         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04833491    
Other Study ID Numbers: xuwen2021-0189
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University:
refractive cataract surgery
intraocular lens
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases