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

Recruitment of Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833491
• Other study ID #: xuwen2021-0189
• Status: Recruiting
• Start date: April 20, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Wen Xu
• Phone: +86-13858185223
• Email: xuwen2003[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Recruitment of Participants

Locations

Country	Name	City	State
China	Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 week postoperatively
Primary	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	1 month postoperatively
Primary	Best Corrected Visual Acuity	The BCVA was measured by the same optometrist at each visit	3 months postoperatively
Primary	Uncorrected distance visual acuity	The UCVA was measured by the same optometrist at each visit	1 week postoperatively
Primary	Uncorrected distance visual acuity	The UCVA was measured by the same optometrist at each visit	1 month postoperatively
Primary	Uncorrected distance visual acuity	The UCVA was measured by the same optometrist at each visit	3 months postoperatively
Primary	Intraocular pressure	Intraocular pressure measured using non-contact tonometer	1 week postoperatively
Primary	Intraocular pressure	Intraocular pressure measured using non-contact tonometer	1 month postoperatively
Primary	Intraocular pressure	Intraocular pressure measured using non-contact tonometer	3 months postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 week postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	1 month postoperatively
Primary	Tear Breakup Time	Tear Breakup Time was performed to assess tear film stability	3 months postoperatively
Primary	Endothelial cell density	Endothelial cell density was measured by specular microscopy	1 month postoperatively
Primary	Contrast sensitivity	The contrast sensitivity was recorded in dark environment, glare dark environment, light environment, glare light environment	1 month postoperatively
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Visual satisfaction	The visual acuity satisfaction of distance / middle / near distance was scored from 0 (totally dissatisfied) to 10 (totally satisfied)	3 months postoperatively