Visual Outcomes of Functional Intraocular Lenses in Catar... | NCT06092164

Studies
Visual Outcomes of Functional Intraocular Lenses in Cataracts

NCT06092164

Sponsor

Eye & ENT Hospital of Fudan University

Status

Not yet recruiting

Last Update Posted

Oct 23, 2023Actual

Enrollment

20,000Estimated

Phase

Not provided

Conditions

Cataract
Visual Quality

Interventions

Not provided

Countries

Not provided

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2023Estimated

Primary Completion Date

Dec 30, 2029Estimated

Completion Date

Dec 30, 2031Estimated

First Submitted Date

Oct 15, 2023

First Submission Date that Met QC Criteria

Oct 15, 2023

First Posted Date

Oct 23, 2023Actual

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

Oct 19, 2023

Last Update Posted Date

Oct 23, 2023Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.

Detailed Description

Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

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

20,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
uncorrected distance visual acuity (UDVA)	uncorrected visual acuity at 5 m	one year
best corrected distance visual acuity (BCVA)	corrected visual acuity at 5 m	one year
uncorrected near visual acuity (UNVA)	uncorrected visual acuity at 40 cm	one year
uncorrected intermediate visual acuity (UIVA)	uncorrected visual acuity at 60 cm	one year

Secondary Outcomes

Measure	Description	Time Frame
HOAs	high order aberrations such as coma	three months
Strehl Ratio	The derivative of point spread function (PSF)	three months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

cataract
age > 18 years

Exclusion Criteria:

amblyopia; previous ocular surgery;
ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Catarct

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Yang	Contact	+8613671632525		jin_er76@hotmail.com

Overall Officials

Name	Affiliation	Role
Jin Yang	Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University	Study Director

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases