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

January 13, 2021 updated by: Yune Zhao, Wenzhou Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 313000
        • Recruiting
        • Wenzhou Medical University
        • Contact:
          • zhangliang li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysfunctional lens index
Time Frame: 2021.01-2021.02
iTrace ocular aberration analyzer（itracey Technologies） to measure the preoperative DLI(Dysfunctional lens index)
2021.01-2021.02

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SS-OCT image of the lens
Time Frame: 2021.01-2021.02
IOL-Master 700 biometer to measure preoperative SS-OCT image of the lens
2021.01-2021.02

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
photos of the anterior segment
Time Frame: 2021.01-2021.02
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
self-scoring of the preoperative visual quality assessment scale
Time Frame: 2021.01-2021.02
self-scoring of the preoperative Catquest-9SF visual quality assessment scale.
2021.01-2021.02

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

February 10, 2021

Study Completion (Anticipated)

February 20, 2021

Study Registration Dates

First Submitted

January 5, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZhao

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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