To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract

March 31, 2021 updated by: Yune Zhao
Approximately 60 participants at Eye Hospital of Wenzhou Medical University during January,2017 to June 2021 will be enroll in our study. And dived them randomly into 2 groups:Progressive Cracking Technique (30 eyes) and Conventional Chop Technique (30 eyes) .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • Eye Hospital of Wenzhou Medical College
        • Contact:

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

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cataract with Grade IV~V nucleus sclerosis
  • Cataract surgery is planned
  • The operation was successful without any complications

Exclusion Criteria:

  • Patients with other diseases that affect the corneal endothelium
  • Has a history of anterior segment surgery
  • Failure to cooperate with follow-up

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Progressive Cracking Technique
Patients with hard nucleus cataract were treated with Progressive Cracking Technique.
Procedure: Progressive Cracking Technique
Performing the cataract surgery with our phaco chop-progressive cracking technique.
Experimental: Conventional Chop Technique
Patients with hard nucleus cataract were treated with Conventional Chop Technique.
Procedure: Conventional Chop Technique
Performing the cataract surgery with Conventional Chop Technique.
Other Names:
  • stop and chop

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal endothelial cell density
Time Frame: up to 1 months
the number of corneal endothelial cells per unit area.
up to 1 months
Coefficient of variation of endothelial cells
Time Frame: up to 1 months
represents the variation coefficient of cell area
up to 1 months
percentage of hexagonal cells of the cells marked
Time Frame: up to 1 months
represents the percentage of hexagon cells,the ideal value is above 50%
up to 1 months
central corneal thickness
Time Frame: up to 1 months
thickness in micrometer
up to 1 months

Collaborators and Investigators

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

Sponsor

Yune Zhao

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)

January 1, 2017

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

March 27, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDD-hard-nucleus cataract

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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