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

• Conditions: Age-Related Cataract
• Interventions: 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.

• Registration Number: NCT04711395
• Lead Sponsor: Wenzhou Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract Surgery Group	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.	-
Non-surgical group	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.	-

Primary Outcome Measures

Name	Time	Method
Dysfunctional lens index	2021.01-2021.02	iTrace ocular aberration analyzer（itracey Technologies） to measure the preoperative DLI(Dysfunctional lens index)

Secondary Outcome Measures

Name	Time	Method
SS-OCT image of the lens	2021.01-2021.02	IOL-Master 700 biometer to measure preoperative SS-OCT image of the lens

Trial Locations

Locations (1)

Wenzhou Medical University; 🇨🇳 Hangzhou, Zhejiang, China