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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

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


Condition or disease Intervention/treatment Phase
Cataract Procedure: enlarged internal incision Procedure: regular 2.2mm incision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: Enlarged internal incision
enlarged the internal incision about 0.4mm
Procedure: enlarged internal incision
enlarging the internal incision about 0.4mm

Placebo Comparator: Regular 2.2mm incision
regular 2.2mm corneal incision for microincision coaxial phacoemulsification
Procedure: regular 2.2mm incision
2.2mm microincision coaxial phacoemulsification




Primary Outcome Measures :
  1. descemet membrane detachment(DMD) [ Time Frame: postoperative 1 week ]
    DMD at the incision observed by anterior segment optical coherence tomography



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Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03976791


Contacts
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Contact: Yizhi Liu, Doctor 87330475 liuyizh@mail.sysu.edu.cn

Locations
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China, Guangdong
Zhongshan Ophthalmic Center Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yizhi Liu, Doctor         
Sponsors and Collaborators
Zhongshan Ophthalmic Center, Sun Yat-sen University
Investigators
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Principal Investigator: Yizhi Liu, Doctor Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03976791     History of Changes
Other Study ID Numbers: 2019KYPJ078
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cataract
Surgical Wound
Lens Diseases
Eye Diseases
Wounds and Injuries