- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04828499
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
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
-
-
Zhejiang
-
Wenzhou, Zhejiang, China, 325027
- Recruiting
- Eye Hospital of Wenzhou Medical College
-
Contact:
- Dandan Wang, MD
- Phone Number: 18258227706
- Email: wangdan4827716@yahoo.com.cn
-
-
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.
|
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.
|
Performing the cataract surgery with Conventional Chop Technique.
Other Names:
|
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
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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