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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04711395
Other study ID # YZhao
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date February 20, 2021

Study information

Verified date January 2021
Source Wenzhou Medical University
Contact zhangliang LI
Phone 13968832833
Email lizhangliang0328@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Before cataract surgery, subjects in the observation group used iTrace ocular aberration analyzer(itracey Technologies)and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale. Healthy subjects in the control group also need to complete the above inspections. After that, three experienced cataract specialist surgeons combined the preoperative optometry data of each subject, the photos of the LOCS III anterior segment and the Catquest-9SF questionnaire score to determine whether each subjects should undergo cataract surgery. The subjects were divided into cataract surgery group and non-surgical group. Finally, statistically study the correlation between the DLI index and the degree of lens opacity that has been collected, and use the ROC curve to calculate the DLI as the best cut-off point of DLI to distinguish whether to perform cataract surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 20, 2021
Est. primary completion date February 10, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria: - Over 40 years old - Healthy volunteers with no history of systemic or ocular diseases - patients with simple age-related cataracts without other ocular diseases - those who can communicate with the tester at a normal level - those who can express their own ideas independently Exclusion Criteria: - irregular corneal astigmatism - corneal opacity - corneal scars - corneal dystrophy - shallow of anterior chamber - retinal abnormalities - history of eye surgery or laser treatment - pupil diameter less than 4.00mm in a dark environment - subjects who did not cooperate well during the examination

Study Design


Related Conditions & MeSH terms


Intervention

Device:
measure the preoperative DLI? SS-OCT image of the lens,?take photos of the anterior segment and self-scoring of the preoperative visual quality assessment scale.
subjects in the observation group and Healthy used iTrace ocular aberration analyzer(itracey Technologies)and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale.

Locations

Country Name City State
China Wenzhou Medical University Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrósio R Jr. Comparison of Dysfunctional Lens Index and Scheimpflug Lens Densitometry in the Evaluation of Age-Related Nuclear Cataracts. J Refract Surg. 2016 Apr;32(4):244-8. doi: 10.3928/1081597X-20160209-01. — View Citation

Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrósio R Jr. Correlations of Objective Metrics for Quantifying Dysfunctional Lens Syndrome With Visual Acuity and Phacodynamics. J Refract Surg. 2017 Feb 1;33(2):79-83. doi: 10.3928/1081597X-20161206-05. — View Citation

Li Z, Yu L, Chen D, Chang P, Wang D, Zhao Y, Liu S, Zhao YE. Dysfunctional Lens Index Serves as a Novel Surgery Decision-Maker for Age-Related Nuclear Cataracts. Curr Eye Res. 2019 Jul;44(7):733-738. doi: 10.1080/02713683.2019.1584676. Epub 2019 Mar 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other photos of the anterior segment anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils 2021.01-2021.02
Other self-scoring of the preoperative visual quality assessment scale self-scoring of the preoperative Catquest-9SF visual quality assessment scale. 2021.01-2021.02
Primary Dysfunctional lens index iTrace ocular aberration analyzer(itracey Technologies) to measure the preoperative DLI(Dysfunctional lens index) 2021.01-2021.02
Secondary SS-OCT image of the lens IOL-Master 700 biometer to measure preoperative SS-OCT image of the lens 2021.01-2021.02
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