Visual Performance of Functional Intraocular Lenses in Cataracts

November 1, 2022 updated by: Eye & ENT Hospital of Fudan University

Visual Performance 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 postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.

Study Type

Interventional

Enrollment (Anticipated)

62

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Eye & ENT Hospital of Fudan University

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • required binocular cataract extraction
  • age > 21 years
  • length of optic axis > 26 mm

Exclusion Criteria:

  • irregular corneal astigmatism > 0.3 um;
  • 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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 839MP group
Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.
Device: trifocal intraocular lens
Binocular implantation of two different trifocal intraocular lens in high myopic cataracts
Other: TFNT00 group
Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.
Device: trifocal intraocular lens
Binocular implantation of two different trifocal intraocular lens in high myopic cataracts

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
objective visual quality
Time Frame: three months
MTF curves
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 (Actual)

April 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

September 19, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Functional IOLs in cataracts

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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