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Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

Primary Purpose

Subluxation of Lens, Surgical Instruments，Cataract

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multifunctional Cataract-assisted Retractor
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subluxation of Lens

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affiliated Hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Multifunctional Cataract-assisted Retractor

Capsule Retractor

Arm Description

Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor

Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor

Outcomes

Primary Outcome Measures

Surgical success rate
Surgical success rate of operation with different retractor

Secondary Outcome Measures

Successful implantation rate of intraocular lens
implantation rate of intraocular lens with different retractor
Visual function
Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart
intraocular pressure
intraocular pressure
endothelial cell count
endothelial cell count

Full Information

First Posted
July 31, 2019
Last Updated
April 2, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04062084
Brief Title
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Official Title
Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subluxation of Lens, Surgical Instruments，Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multifunctional Cataract-assisted Retractor
Arm Type
Experimental
Arm Description
Patients undergoing cataract with lens subluxation surgery with Multifunctional cataract-assisted retractor
Arm Title
Capsule Retractor
Arm Type
Experimental
Arm Description
Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor
Intervention Type
Device
Intervention Name(s)
Multifunctional Cataract-assisted Retractor
Intervention Description
Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens
Primary Outcome Measure Information:
Title
Surgical success rate
Description
Surgical success rate of operation with different retractor
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Successful implantation rate of intraocular lens
Description
implantation rate of intraocular lens with different retractor
Time Frame
through study completion, an average of 1 year
Title
Visual function
Description
Best corrected visual acuity (BCVA) measured using a decimal chart Best corrected visual acuity (BCVA) measured using a decimal chart
Time Frame
1day postoperation，1 week，1 month， 3month postoperation
Title
intraocular pressure
Description
intraocular pressure
Time Frame
1 day, 1 week, 1 month, and 3 month postoperation
Title
endothelial cell count
Description
endothelial cell count
Time Frame
1 week, 1 month, and 3 month postoperation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Second Affiliated Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of Multifunctional Cataract-assisted Retractor in Complicated Cataract Surgery

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