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NCT Number: NCT04833491

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

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.

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Key information

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location status: Recruiting

Location contact

Wen Xu

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2021
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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