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

NCT04711395 | Unknown

• 1 other identifier: YZhao
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Cataract

Keywords

Age-related cataract; DLI

Outcome Measures

Primary Outcomes (1)

• Dysfunctional lens index

  iTrace ocular aberration analyzer（itracey Technologies） to measure the preoperative DLI(Dysfunctional lens index)

  2021.01-2021.02

Secondary Outcomes (1)

• SS-OCT image of the lens

  2021.01-2021.02

Other Outcomes (2)

• photos of the anterior segment

  2021.01-2021.02

• self-scoring of the preoperative visual quality assessment scale

  2021.01-2021.02

Study Arms (2)

Cataract Surgery Group

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.

Non-surgical group

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.

Interventions

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. 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.

Cataract Surgery Group; Non-surgical group

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with simple age-related cataracts and healthy patients without systemic or eye diseases attending the Eye Optometry Hospital of Wenzhou Medical University

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenzhou Medical University: lead

Study Sites (1)

Wenzhou Medical University

Hangzhou, Zhejiang, 313000, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 27070231 BACKGROUND

• 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.

  PMID: 28192585 BACKGROUND

• 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.

  PMID: 30822168 BACKGROUND

Related Links

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

Central Study Contacts

zhangliang LI

CONTACT

13968832833; lizhangliang0328@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Dean

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 15, 2021
• Study Start: November 1, 2020
• Primary Completion: February 10, 2021
• Study Completion: February 20, 2021
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

CN (1)