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Visual Performance of Functional Intraocular Lenses in Cataracts

Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05581888
Collaborator
(none)
62
Enrollment
1
Location
2
Arms
35.9
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

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

Condition or Disease Intervention/Treatment Phase
  • Device: trifocal intraocular lens
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
Actual Study Start Date :
Apr 1, 2020
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. uncorrected distance visual acuity (UDVA) [one year]

    uncorrected visual acuity at 5 m

  2. best corrected distance visual acuity (BCVA) [one year]

    corrected visual acuity at 5 m

  3. uncorrected near visual acuity (UNVA) [one year]

    uncorrected visual acuity at 40 cm

  4. uncorrected intermediate visual acuity (UIVA) [one year]

    uncorrected visual acuity at 60 cm

Secondary Outcome Measures

  1. HOAs [three months]

    high order aberrations such as coma

  2. Strehl Ratio [three months]

    The derivative of point spread function (PSF)

  3. objective visual quality [three months]

    MTF curves

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye & ENT Hospital of Fudan University Shanghai Shanghai China 200031

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:
Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier:
NCT05581888
Other Study ID Numbers:
  • Functional IOLs in cataracts
First Posted:
Oct 17, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Eye & ENT Hospital of Fudan University
Visual performance
Trifocal IOL
High myopic cataract
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Nov 3, 2022