Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Ss-oct and Scheimpflug Technology

September 18, 2021 updated by: Yune Zhao, Wenzhou Medical University

Correlation Analysis of Lens Nucleus Density and Surgical Parameters Based on Long-range Swept-source Optical Coherence Tomography and Scheimpflug Technology

To study the correlation between three different lens nuclear opacity classification methods and intraoperative phacoemulsification parameters .

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Slit-lamp lens images, Pentacam and IOL-Master 700 images were collected in patients with dilated pupil before cataract surgery, and phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded. Spearman correlation analysis was used to analyze the correlation between lens nuclear density and phacoemulsification parameters based on SS-OCT and Scheimpflug techniques.

Study Type

Observational

Enrollment (Anticipated)

53

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
      • Wenzhou, Zhejiang, China, 325027
        • Ophthalmology and Optometry Hospital

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

In this study, age-related cataract patients who met the criteria for cataract surgery and underwent cataract surgery by the same surgeon in our hospital were included.

Description

Inclusion Criteria:

  1. Age-related cataracts performed by the same surgeon in our hospital;
  2. Pupil diameter can be enlarged more than 6 millimetre.

Exclusion Criteria:

  1. The pupil diameter cannot be dilated greater than 6mm;
  2. previously ocular surgery or laser treatment;
  3. history of ocular trauma;
  4. other ocular diseases such as keratoconus, glaucoma and retinal detachment;
  5. corneal opacities caused by leucoma, pterygium and other diseases;
  6. lens dislocation or complicated cataract surgery (any complications during/after the operations);
  7. poor fixation leading to low image quality or inability to cooperate with examinations.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lens nuclear opalescence(NO) and nuclear colour (NC)
Time Frame: 2021.12.30
After the maximumly pupil dilation, the same experienced ophthalmologist examined all the eyes with slit-lamp digital cameras in dark conditions and scored the lens nuclear opalescence(NO) and nuclear colour (NC) on a scale of 0.1-6.9 according to LOCS III criteria.
2021.12.30
Pentacam mean nuclear density (PND)
Time Frame: 2021.12.30
After the maximumly pupil dilation, Pentacam HR was used to acquire the Scheimpflug images of the lens, and the average density reading for the entire nucleus provided by PNS function was defined as Pentacam mean nuclear density (PND), ranging from 0% to 100%.
2021.12.30
Mean nucleus density (MND) of the lens presented by IOL-Master 700
Time Frame: 2021.12.30
After the maximumly pupil dilation, the inspected eyes are asked to focus on the indicator light to obtain a high-definition image of the lens. The image is derived to the ImageJ software, and the contour of the lens nucleus is manually drawn. The pixel density of the image within the contour is measured, with a value range of 0-255.The mean pixel density within the region was used to represent the mean nucleus density (MND) of the lens presented by IOL-Master 700.For each eye, the SS-OCT nucleus density is defined as the average of six readings from the corresponding image.
2021.12.30
Intraoperative phacoemulsification parameters
Time Frame: 2021.12.30
The intraoperative phacoemulsification parameters on the Centurion phacoemulsification machine (Alcon) screen were recorded after surgery.
2021.12.30

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

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 (ANTICIPATED)

October 1, 2021

Primary Completion (ANTICIPATED)

December 30, 2021

Study Completion (ANTICIPATED)

December 30, 2021

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (ACTUAL)

August 31, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 21, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LZL nucleus density

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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