Clinical trial NCT04711395: The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery
Official title: The Application of Lens Dysfunction Index (DLI) in the Timing of Age-related Cataract Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Cataract
Keywords: Age-related cataract
DLI
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Dysfunctional lens index
timeFrame: 2021.01-2021.02
Secondary outcomes:
measure: SS-OCT image of the lens
timeFrame: 2021.01-2021.02
Other outcomes:
measure: photos of the anterior segment
timeFrame: 2021.01-2021.02
measure: self-scoring of the preoperative visual quality assessment scale
timeFrame: 2021.01-2021.02
Locations:
city: Hangzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.
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.