The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery

Age-Related Cataract Clinical Trial

Official title:

The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04711395
• Other study ID #: YZhao
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Age-Related Cataract
• Cataract

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

External Links

•   Comparison of Dysfunctional Lens Index and Scheimpflug Lens Densitometry in the Evaluation of Age-Related Nuclear Cataracts
•   Correlations of Objective Metrics for Quantifying Dysfunctional Lens Syndrome With Visual Acuity and Phacodynamics
•   Dysfunctional Lens Index Serves as a Novel Surgery Decision-Maker for Age-Related Nuclear Cataracts