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Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04062084
Recruitment Status : Active, not recruiting
First Posted : August 20, 2019
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
To compare the safety and efficacy of a new multi-functional cataract-assisted surgical instrument with that of traditional cataract-assisted surgical instrument in cataract surgery with subluxation of lens.

Condition or disease Intervention/treatment Phase
Subluxation of Lens Surgical Instruments,Cataract Device: Multifunctional Cataract-assisted Retractor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: Multifunctional Cataract-assisted Retractor
Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor
Device: Multifunctional Cataract-assisted Retractor
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Experimental: Capsule Retractor
Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor
Device: Multifunctional Cataract-assisted Retractor
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens




Primary Outcome Measures :
  1. Surgical success rate [ Time Frame: through study completion, an average of 1 year ]
    Surgical success rate of operation with different retractor


Secondary Outcome Measures :
  1. Successful implantation rate of intraocular lens [ Time Frame: through study completion, an average of 1 year ]
    implantation rate of intraocular lens with different retractor

  2. Visual function [ Time Frame: 1day postoperation,1 week,1 month, 3month postoperation ]
    Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart

  3. intraocular pressure [ Time Frame: 1 day, 1 week, 1 month, and 3 month postoperation ]
    intraocular pressure

  4. endothelial cell count [ Time Frame: 1 week, 1 month, and 3 month postoperation ]
    endothelial cell count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of lens subluxation.
  • Patients need to undergo lens subluxation surgery

Exclusion Criteria:

  • Active intraocular inflammation
  • The intraocular pressure (IOP) was higher than 25 mmHg
  • The endothelial cell count (ECC) was less than 1,200 cells/mm2
  • Combined with other eye diseases
  • Combined with other serious systemic diseases

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): NCT04062084


Locations
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China, Zhejiang
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04062084    
Other Study ID Numbers: xuwen2017-034
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Lens Subluxation
Lens Diseases
Eye Diseases