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

NCT04828499 | Unknown

• 1 other identifier: WDD-hard-nucleus cataract
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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) .

Conditions

Hard Nuclear Cataract; Corneal Endothelial Cell; Progressive Cracking Technique

Outcome Measures

Primary Outcomes (4)

• corneal endothelial cell density

  the number of corneal endothelial cells per unit area.

  up to 1 months

• Coefficient of variation of endothelial cells

  represents the variation coefficient of cell area

  up to 1 months

• percentage of hexagonal cells of the cells marked

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

  up to 1 months

• central corneal thickness

  thickness in micrometer

  up to 1 months

Study Arms (2)

Progressive Cracking Technique

EXPERIMENTAL

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

Procedure: Progressive Cracking Technique

Conventional Chop Technique

EXPERIMENTAL

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

Procedure: Conventional Chop Technique

Interventions

Progressive Cracking Technique PROCEDURE

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

Progressive Cracking Technique

Conventional Chop Technique PROCEDURE

Performing the cataract surgery with Conventional Chop Technique.

Also known as: stop and chop

Conventional Chop Technique

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yune Zhao: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

RECRUITING

MeSH Terms

Interventions

Transcription Factor CHOP

Intervention Hierarchy (Ancestors)

CCAAT-Enhancer-Binding Proteins; Basic-Leucine Zipper Transcription Factors; DNA-Binding Proteins; Proteins; Amino Acids, Peptides, and Proteins; Nuclear Proteins; Transcription Factors

Central Study Contacts

Dandan Wang

CONTACT

18258227706; wangdan4827716@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 2, 2021
• Study Start: January 1, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-03

Locations

CN (1)