NCT05581888

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 17, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 3, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

September 19, 2022

Last Update Submit

November 1, 2022

Conditions

High MyopiaCataract

Keywords

Visual performanceTrifocal IOLHigh myopic cataract

Outcome Measures

Primary Outcomes (4)

  • 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 (3)

  • HOAs

    three months

  • Strehl Ratio

    three months

  • objective visual quality

    three months

Study Arms (2)

839MP group

OTHER

Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.

Device: trifocal intraocular lens

TFNT00 group

OTHER

Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.

Device: trifocal intraocular lens

Interventions

trifocal intraocular lensDEVICE

Binocular implantation of two different trifocal intraocular lens in high myopic cataracts

839MP groupTFNT00 group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jin Yang

    Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2022

First Posted

October 17, 2022

Study Start

April 1, 2020

Primary Completion

June 30, 2021

Study Completion

March 31, 2023

Last Updated

November 3, 2022

Record last verified: 2022-11

Locations

CN(1)