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

NCT04833491 | Recruiting

• 1 other identifier: xuwen2021-0189
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Recruitment of Participants

Keywords

refractive cataract surgery; intraocular lens

Outcome Measures

Primary Outcomes (19)

• Best Corrected Visual Acuity

  The BCVA was measured by the same optometrist at each visit

  1 week postoperatively

• Best Corrected Visual Acuity

  The BCVA was measured by the same optometrist at each visit

  1 month postoperatively

• Best Corrected Visual Acuity

  The BCVA was measured by the same optometrist at each visit

  3 months postoperatively

• Uncorrected distance visual acuity

  The UCVA was measured by the same optometrist at each visit

  1 week postoperatively

• Uncorrected distance visual acuity

  The UCVA was measured by the same optometrist at each visit

  1 month postoperatively

• Uncorrected distance visual acuity

  The UCVA was measured by the same optometrist at each visit

  3 months postoperatively

• Intraocular pressure

  Intraocular pressure measured using non-contact tonometer

  1 week postoperatively

• Intraocular pressure

  Intraocular pressure measured using non-contact tonometer

  1 month postoperatively

• Intraocular pressure

  Intraocular pressure measured using non-contact tonometer

  3 months postoperatively

• Tear Breakup Time

  Tear Breakup Time was performed to assess tear film stability

  1 week postoperatively

• Tear Breakup Time

  Tear Breakup Time was performed to assess tear film stability

  1 month postoperatively

• Tear Breakup Time

  Tear Breakup Time was performed to assess tear film stability

  3 months postoperatively

• Endothelial cell density

  Endothelial cell density was measured by specular microscopy

  1 month postoperatively

• Contrast sensitivity

  The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment

  1 month postoperatively

• Defocusing curve

  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

  1 month postoperatively

• Stereoscopic vision

  The binocular diopter was not corrected. The stereopsis test card was used to record the arc seconds of random points, animals and circles

  1 month postoperatively

• Glasses usage frequency

  The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%

  3 months postoperatively

• Optical visual quality questionnaire

  Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)

  3 months postoperatively

• Visual satisfaction

  The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)

  3 months postoperatively

Study Arms (5)

Senile cataract

Traumatic cataract

Congenital cataract

Lens dislocation group

Complicated cataract

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cataract surgery was performed in ophthalmic hospital affiliated to Medical College of Zhejiang University

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Related Publications (2)

• Fang J, Shi C, Ma X, Sheng S, Xu J, Zhu S, Feng Y, Zhang Y, Liu L, Zhao H, Xu Z, Xu W. Anterior segment characteristics and spatial variations of different crystalline lens diseases. Photodiagnosis Photodyn Ther. 2025 Aug;54:104693. doi: 10.1016/j.pdpdt.2025.104693. Epub 2025 Jun 26.

  PMID: 40581199 DERIVED

• Xu Z, Wang J, Shi C, Ni S, Xu J, Zhu S, Fang J, Xu W. Clinical outcomes of plate-haptic diffractive multifocal toric IOL in cataract eyes with long axial length and corneal astigmatism. Sci Rep. 2025 Apr 7;15(1):11881. doi: 10.1038/s41598-025-97040-0.

  PMID: 40195538 DERIVED

Central Study Contacts

Wen Xu

CONTACT

+86-13858185223; xuwen2003@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 6, 2021
• Study Start: April 20, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 10, 2021

Record last verified: 2021-03

Locations

CN (1)