Visual Outcomes of Functional Intraocular Lenses in Cataracts

October 19, 2023 updated by: Jin Yang, Eye & ENT Hospital of Fudan University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Catarct

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

December 30, 2029

Study Completion (Estimated)

December 30, 2031

Study Registration Dates

First Submitted

October 15, 2023

First Submitted That Met QC Criteria

October 15, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOL Outcomes in cataracts

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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