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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Wen Xu; Phone Number: +86-13858185223; Email: xuwen2003@zju.edu.cn

Study Locations

• China
  • Hangzhou, China
    • Recruiting
    • Second Affiliated Hospital, Zhejiang University School of Medicine
    • Contact: Wen Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort
Senile cataract
Traumatic cataract
Congenital cataract
Lens dislocation group
Complicated cataract

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 4, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: intraocular lens; refractive cataract surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: xuwen2021-0189

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No