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

Recruiting

• Conditions: Recruitment of Participants

• Registration Number: NCT04833491
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

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 Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-04-02
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-06
• Study Start: 2021-04-20
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	3 months postoperatively	The BCVA was measured by the same optometrist at each visit
Tear Breakup Time	3 months postoperatively	Tear Breakup Time was performed to assess tear film stability
Uncorrected distance visual acuity	3 months postoperatively	The UCVA was measured by the same optometrist at each visit
Intraocular pressure	3 months postoperatively	Intraocular pressure measured using non-contact tonometer
Glasses usage frequency	3 months postoperatively	The frequency of long / medium / short distance use of corrective glasses was scored as 0%, 25%, 50%, 75% and 100%
Optical visual quality questionnaire	3 months postoperatively	Glare, halos, starburst and other visual quality problems were graded as mild（1 score), moderate（2 score) and severe（3 score)
Endothelial cell density	1 month postoperatively	Endothelial cell density was measured by specular microscopy
Contrast sensitivity	1 month postoperatively	The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment
Stereoscopic vision	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
Defocusing curve	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
Visual satisfaction	3 months postoperatively	The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)

Trial Locations

Locations (1)

Second Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China