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

Sponsor
Yune Zhao (Other)
Overall Status
Recruiting
CT.gov ID
NCT04828499
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
53.9
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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) .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Progressive Cracking Technique
  • Procedure: Conventional Chop Technique
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Jun 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. corneal endothelial cell density [up to 1 months]

      the number of corneal endothelial cells per unit area.

    2. Coefficient of variation of endothelial cells [up to 1 months]

      represents the variation coefficient of cell area

    3. percentage of hexagonal cells of the cells marked [up to 1 months]

      represents the percentage of hexagon cells,the ideal value is above 50%

    4. central corneal thickness [up to 1 months]

      thickness in micrometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Hospital of Wenzhou Medical College Wenzhou Zhejiang China 325027

    Sponsors and Collaborators

    • Yune Zhao

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
    ClinicalTrials.gov Identifier:
    NCT04828499
    Other Study ID Numbers:
    • WDD-hard-nucleus cataract
    First Posted:
    Apr 2, 2021
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cataract

    Study Results

    No Results Posted as of Apr 2, 2021