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

NCT ID: NCT04711395

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-02-20

Brief Summary

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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

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Conditions

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Age-Related Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intervention Type DEVICE

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.

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.

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yune Zhao

Deputy Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wenzhou Medical University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhangliang LI

Role: CONTACT

13968832833

Facility Contacts

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zhangliang li

Role: primary

References

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Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrosio 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.

Reference Type BACKGROUND
PMID: 27070231 (View on PubMed)

Faria-Correia F, Ramos I, Lopes B, Monteiro T, Franqueira N, Ambrosio 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.

Reference Type BACKGROUND
PMID: 28192585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30822168 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/30822168/

Dysfunctional Lens Index Serves as a Novel Surgery Decision-Maker for Age-Related Nuclear Cataracts

https://pubmed.ncbi.nlm.nih.gov/27070231/

Comparison of Dysfunctional Lens Index and Scheimpflug Lens Densitometry in the Evaluation of Age-Related Nuclear Cataracts

https://pubmed.ncbi.nlm.nih.gov/28192585/

Correlations of Objective Metrics for Quantifying Dysfunctional Lens Syndrome With Visual Acuity and Phacodynamics

Other Identifiers

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YZhao

Identifier Type: -

Identifier Source: org_study_id

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