Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

April 2, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical success rate
Time Frame: through study completion, an average of 1 year
Surgical success rate of operation with different retractor
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful implantation rate of intraocular lens
Time Frame: through study completion, an average of 1 year
implantation rate of intraocular lens with different retractor
through study completion, an average of 1 year
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
1day postoperation，1 week，1 month， 3month postoperation
intraocular pressure
Time Frame: 1 day, 1 week, 1 month, and 3 month postoperation
intraocular pressure
1 day, 1 week, 1 month, and 3 month postoperation
endothelial cell count
Time Frame: 1 week, 1 month, and 3 month postoperation
endothelial cell count
1 week, 1 month, and 3 month postoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

November 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 19, 2019

First Posted (Actual)

August 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 5, 2021

Last Update Submitted That Met QC Criteria

April 2, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • xuwen2017-034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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