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A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

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ClinicalTrials.gov Identifier: NCT03976791
Recruitment Status : Not yet recruiting
First Posted : June 6, 2019
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Zhongshan Ophthalmic Center, Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE June 4, 2019
First Posted Date  ICMJE June 6, 2019
Last Update Posted Date June 14, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
descemet membrane detachment(DMD) [ Time Frame: postoperative 1 week ]
DMD at the incision observed by anterior segment optical coherence tomography
Original Primary Outcome Measures  ICMJE
 (submitted: June 4, 2019)
descemet membrane detachment(DMD) [ Time Frame: postoperative 1 day ]
DMD at the incision
Change History Complete list of historical versions of study NCT03976791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Official Title  ICMJE A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Brief Summary

Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision.

The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification.

Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification.

Study Design: A prospective randomized controlled study

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cataract
Intervention  ICMJE
  • Procedure: enlarged internal incision
    enlarging the internal incision about 0.4mm
  • Procedure: regular 2.2mm incision
    2.2mm microincision coaxial phacoemulsification
Study Arms  ICMJE
  • Experimental: Enlarged internal incision
    enlarged the internal incision about 0.4mm
    Intervention: Procedure: enlarged internal incision
  • Placebo Comparator: Regular 2.2mm incision
    regular 2.2mm corneal incision for microincision coaxial phacoemulsification
    Intervention: Procedure: regular 2.2mm incision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
294
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age-related cataract patients
  • Age from 65 to 90
  • The diameter of pupil after mydriasis is more than 6 mm
  • LOCS III nuclear grade ≥4
  • Corneal endothelial cell count > 1500 cells/mm2
  • Phacoemulsification and intraocular lens implantation are planned
  • Agree to participate in this study and sign informed consent

Exclusion Criteria:

  • History of ocular trauma
  • Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma)
  • Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors
  • History of Ophthalmic Surgery
  • Intraoperative and Postoperative Complications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 90 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Yizhi Liu, Doctor 87330475 liuyizh@mail.sysu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03976791
Other Study ID Numbers  ICMJE 2019KYPJ078
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhongshan Ophthalmic Center, Sun Yat-sen University
Study Sponsor  ICMJE Zhongshan Ophthalmic Center, Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yizhi Liu, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University
PRS Account Zhongshan Ophthalmic Center, Sun Yat-sen University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP