Visual Outcomes of Functional Intraocular Lenses in Cataracts

Sponsor

Eye & ENT Hospital of Fudan University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06092164

Collaborator

(none)

20,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Visual Quality

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."

Study Design

Study Type:

Observational

Anticipated Enrollment :

20000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2029

Anticipated Study Completion Date :

Dec 30, 2031

Outcome Measures

Primary Outcome Measures

uncorrected distance visual acuity (UDVA) [one year]
uncorrected visual acuity at 5 m
best corrected distance visual acuity (BCVA) [one year]
corrected visual acuity at 5 m
uncorrected near visual acuity (UNVA) [one year]
uncorrected visual acuity at 40 cm
uncorrected intermediate visual acuity (UIVA) [one year]
uncorrected visual acuity at 60 cm

Secondary Outcome Measures

HOAs [three months]
high order aberrations such as coma
Strehl Ratio [three months]
The derivative of point spread function (PSF)
objective visual quality [three months]
The modulation transfer function (MTF) curve
contrast sensitivity [three months]
Contrast sensitivity were obtained from the Functional Vision Analyzer
visual functions [three months]
Visual functions were obtained from the OCULUS Binoptometer 4P
IOL condition [three months]
IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.
subjective satisfaction [three years]
Satisfaction Questionnaire
photic phenomena [three years]
Questionnaire of photic phenomena

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Eye & ENT Hospital of Fudan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin Yang, Professor, Eye & ENT Hospital of Fudan University

ClinicalTrials.gov Identifier:

NCT06092164

Other Study ID Numbers:

IOL Outcomes in cataracts

First Posted:

Oct 23, 2023

Last Update Posted:

Oct 23, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Oct 23, 2023