Hard Nuclear CataractNCT04828499
To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
A study testing Progressive Cracking Technique and Conventional Chop Technique in people with Hard Nuclear Cataract and Corneal Endothelial Cell, run by Yune Zhao at 1 site in China.
Trial 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) . Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Hard Nuclear Cataract, Corneal Endothelial Cell, Progressive Cracking Technique
- What is being tested?
- Progressive Cracking Technique and Conventional Chop Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract with Grade IV~V nucleus sclerosis
- Cataract surgery is planned
- The operation was successful without any complications
Who cannot join
- Patients with other diseases that affect the corneal endothelium
- Has a history of anterior segment surgery
- Failure to cooperate with follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325027
Dandan Wang, MD, 18258227706, wangdan4827716@yahoo.com.cn
About this study
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) .
- Being tested
- Progressive Cracking Technique, Conventional Chop Technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Cracking TechniqueProcedure or surgery
Performing the cataract surgery with our phaco chop-progressive cracking technique.
Conventional Chop TechniqueProcedure or surgery
Also called stop and chop
Performing the cataract surgery with Conventional Chop Technique.
| Study group | Role | What they receive |
|---|---|---|
| Progressive Cracking Technique | Experimental | Patients with hard nucleus cataract were treated with Progressive Cracking Technique. Receives: Procedure: Progressive Cracking Technique |
| Conventional Chop Technique | Experimental | Patients with hard nucleus cataract were treated with Conventional Chop Technique. Receives: Procedure: Conventional Chop Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal endothelial cell density
the number of corneal endothelial cells per unit area.
Measured: up to 1 months
Coefficient of variation of endothelial cells
represents the variation coefficient of cell area
Measured: up to 1 months
percentage of hexagonal cells of the cells marked
represents the percentage of hexagon cells,the ideal value is above 50%
Measured: up to 1 months
central corneal thickness
thickness in micrometer
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 Jan 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hard Nuclear CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yune Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828499
- Sponsor's protocol ID
- WDD-hard-nucleus cataract
- Status last verified
- Mar 2021
- First submitted
- 27 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the Progressive Cracking Technique and Conventional Chop Technique on Corneal Endothelial Cells in Patients With Hard Nucleus Cataract
- ClinicalTrials.gov ID
- NCT04828499
- Acronym / sponsor ID
- WDD-hard-nucleus cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yune ZhaoUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Progressive Cracking Technique | Experimental | Procedure: Progressive Cracking TechniquePatients with hard nucleus cataract were treated with Progressive Cracking Technique. |
| Conventional Chop Technique | Experimental | Procedure: Conventional Chop TechniquePatients with hard nucleus cataract were treated with Conventional Chop Technique. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataract with Grade IV~V nucleus sclerosis
- Cataract surgery is planned
- The operation was successful without any complications
Key exclusion criteria (3 listed)
- Patients with other diseases that affect the corneal endothelium
- Has a history of anterior segment surgery
- Failure to cooperate with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Cracking TechniquePerforming the cataract surgery with our phaco chop-progressive cracking technique. | Procedure or surgery | Progressive Cracking Technique |
| Conventional Chop TechniqueAlso: stop and chopPerforming the cataract surgery with Conventional Chop Technique. | Procedure or surgery | Conventional Chop Technique |
Primary outcome
corneal endothelial cell density
Time frame: up to 1 months
the number of corneal endothelial cells per unit area.
Coefficient of variation of endothelial cells
Time frame: up to 1 months
represents the variation coefficient of cell area
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%
central corneal thickness
Time frame: up to 1 months
thickness in micrometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Hard Nuclear Cataract
RecruitingPhase 2
A Study of CA201A Eye Drops to Prevent Corneal Endothelial Cell Loss in Patients Undergoing Cataract Surgery
Corneal Endothelial Cell Loss, Corneal Endothelial Damage Following the Hard Nuclear Cataract Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Cracking Technique and Conventional Chop Technique in people with Hard Nuclear Cataract and Corneal Endothelial Cell, run by Yune Zhao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dandan Wang (18258227706, wangdan4827716@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal endothelial cell density (time frame: up to 1 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2021; AzTrials last refreshed its copy on 29 Oct 2026.