Back to resultsTo Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Primary Purpose
Hard Nuclear Cataract, Corneal Endothelial Cell, Progressive Cracking Technique
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Progressive Cracking Technique
Conventional Chop Technique
Sponsored by
About this trial
This is an interventional treatment trial for Hard Nuclear Cataract
Eligibility Criteria
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
Sites / Locations
- Eye Hospital of Wenzhou Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Progressive Cracking Technique
Conventional Chop Technique
Arm Description
Patients with hard nucleus cataract were treated with Progressive Cracking Technique.
Patients with hard nucleus cataract were treated with Conventional Chop Technique.
Outcomes
Primary Outcome Measures
corneal endothelial cell density
the number of corneal endothelial cells per unit area.
Coefficient of variation of endothelial cells
represents the variation coefficient of cell area
percentage of hexagonal cells of the cells marked
represents the percentage of hexagon cells,the ideal value is above 50%
central corneal thickness
thickness in micrometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04828499
Brief Title
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Official Title
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yune Zhao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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) .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard Nuclear Cataract, Corneal Endothelial Cell, Progressive Cracking Technique
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Progressive Cracking Technique
Arm Type
Experimental
Arm Description
Patients with hard nucleus cataract were treated with Progressive Cracking Technique.
Arm Title
Conventional Chop Technique
Arm Type
Experimental
Arm Description
Patients with hard nucleus cataract were treated with Conventional Chop Technique.
Intervention Type
Procedure
Intervention Name(s)
Progressive Cracking Technique
Intervention Description
Performing the cataract surgery with our phaco chop-progressive cracking technique.
Intervention Type
Procedure
Intervention Name(s)
Conventional Chop Technique
Other Intervention Name(s)
stop and chop
Intervention Description
Performing the cataract surgery with Conventional Chop Technique.
Primary Outcome Measure Information:
Title
corneal endothelial cell density
Description
the number of corneal endothelial cells per unit area.
Time Frame
up to 1 months
Title
Coefficient of variation of endothelial cells
Description
represents the variation coefficient of cell area
Time Frame
up to 1 months
Title
percentage of hexagonal cells of the cells marked
Description
represents the percentage of hexagon cells,the ideal value is above 50%
Time Frame
up to 1 months
Title
central corneal thickness
Description
thickness in micrometer
Time Frame
up to 1 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dandan Wang
Phone
18258227706
Email
wangdan4827716@yahoo.com.cn
Facility Information:
Facility Name
Eye Hospital of Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dandan Wang, MD
Phone
18258227706
Email
wangdan4827716@yahoo.com.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
We'll reach out to this number within 24 hrs