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Status unknownNCT04828499Updated Apr 2, 2021

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

An interventional study of Progressive Cracking Technique and Conventional Chop Technique in Hard Nuclear Cataract, Corneal Endothelial Cell and Progressive Cracking Technique, sponsored by Yune Zhao. Status unknown at 1 site in China. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-02.

Sponsored by Yune Zhao · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 years 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study 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) .

02

Conditions studied

  • Hard Nuclear Cataract
  • Corneal Endothelial Cell
  • Progressive Cracking Technique

Browse trials for

03

In context

Cataract

1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.

This study's planned enrollment of 60 is below the median of 79 across 1,092 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Yune Zhao is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with other diseases that affect the corneal endothelium
  • Has a history of anterior segment surgery
  • Failure to cooperate with follow-up
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Progressive Cracking Technique

    Patients with hard nucleus cataract were treated with Progressive Cracking Technique.

    Procedure: Progressive Cracking Technique

  • Experimental
    Conventional Chop Technique

    Patients with hard nucleus cataract were treated with Conventional Chop Technique.

    Procedure: Conventional Chop Technique

Interventions

  • ProcedureProgressive Cracking Technique

    Performing the cataract surgery with our phaco chop-progressive cracking technique.

  • ProcedureConventional Chop Technique

    Performing the cataract surgery with Conventional Chop Technique.

    Also known as: stop and chop

06

What researchers measure

Primary outcomes

  1. corneal endothelial cell density

    the number of corneal endothelial cells per unit area.

    Time frame: up to 1 months

  2. Coefficient of variation of endothelial cells

    represents the variation coefficient of cell area

    Time frame: up to 1 months

  3. percentage of hexagonal cells of the cells marked

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

    Time frame: up to 1 months

  4. central corneal thickness

    thickness in micrometer

    Time frame: up to 1 months

07

Study locations

1 of 1 sites recruiting
  • Eye Hospital of Wenzhou Medical College
    Wenzhou, Zhejiang 325027, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2017 (actual). Primary completion is estimated for Jun 2021, 53 months after the start.

Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 53 months is above that.

Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2021
First posted
Apr 2, 2021
StartActual
Jan 1, 2017
Primary completionEst.
Jun 30, 2021
CompletionEst.
Jun 30, 2021
Last update
Apr 2, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04828499
Lead sponsor
Yune Zhao
Responsible party
Yune Zhao (Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University) — Sponsor-investigator
First posted
Apr 2, 2021
Start date
Jan 1, 2017
Primary completion
Jun 30, 2021 (estimated)
Completion
Jun 30, 2021 (estimated)
Last update
Apr 2, 2021

Study contacts

Dandan Wang
Contact
wangdan4827716@yahoo.com.cn
18258227706

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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