NCT04062084

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

April 5, 2021

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

July 31, 2019

Last Update Submit

April 2, 2021

Conditions

Subluxation of LensSurgical Instruments，Cataract

Outcome Measures

Primary Outcomes (1)

  • Surgical success rate

    Surgical success rate of operation with different retractor

    through study completion, an average of 1 year

Secondary Outcomes (4)

  • Successful implantation rate of intraocular lens

    through study completion, an average of 1 year

  • Visual function

    1day postoperation，1 week，1 month， 3month postoperation

  • intraocular pressure

    1 day, 1 week, 1 month, and 3 month postoperation

  • endothelial cell count

    1 week, 1 month, and 3 month postoperation

Study Arms (2)

Multifunctional Cataract-assisted Retractor

EXPERIMENTAL

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

Device: Multifunctional Cataract-assisted Retractor

Capsule Retractor

EXPERIMENTAL

Patients undergoing cataract with lens subluxation surgery with traditional capsule retractor

Device: Multifunctional Cataract-assisted Retractor

Interventions

Multifunctional Cataract-assisted RetractorDEVICE

Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens

Capsule RetractorMultifunctional Cataract-assisted Retractor

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2019

First Posted

August 20, 2019

Study Start

September 1, 2019

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

April 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)