Effective Lens Position After Cataract Surgery | NCT04443101

Studies
Effective Lens Position After Cataract Surgery

NCT04443101

Sponsor

Wenzhou Medical University

Status

Unknown status

Last Update Posted

Mar 7, 2023Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Age-related Cataract

Interventions

different types of intracular lens

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

May 30, 2022Actual

Completion Date

Mar 30, 2023Estimated

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 22, 2020

First Posted Date

Jun 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 5, 2023

Last Update Posted Date

Mar 7, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

yin ying zhao, Principal Investigator, Wenzhou Medical UniversityPrincipal Investigator

Lead Sponsor

Wenzhou Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.

Detailed Description

Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Group（SN6CWS）	Group（SN6CWS）：Implant SN6CWS intraocular lens	Other: different types of intracular lens
Group（MI60）	Group（MI60）：Implant MI60 intraocular lens	Other: different types of intracular lens
Group（Aspira-aA）	Group（Aspira-aA）：Implant Aspira-aA intraocular lens	Other: different types of intracular lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
different types of intracular lens	Other	different types of intracular lens	Group（Aspira-aA） Group（MI60） Group（SN6CWS）

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
effective lens position	Changes of effective lens position at different time points after cataract surgery	up to 3 months after cataract surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a.Diagnosed as cataract;
b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
c.Cataract phacoemulsification and intraocular lens implantation.

Exclusion Criteria:

a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;
b.A history of intraocular surgery or trauma other than cataract surgery;
c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;
d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;
e.Those with incomplete data collected during the follow-up period of postoperative patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Diagnosed as cataract in our hospital;
Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;
Cataract phacoemulsification and intraocular lens implantation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
xixia ding, Phd	Contact	+8613780148109		dingxixiaxc@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmology and Optometry Hospital	Recruiting	Wenzhou	Zhejiang	325027	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided