Visual Performance of Functional Intraocular Lenses in Cataracts

NCT ID: NCT05581888

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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High Myopia Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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839MP group

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

Group Type OTHER

trifocal intraocular lens

Intervention Type DEVICE

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

TFNT00 group

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

Group Type OTHER

trifocal intraocular lens

Intervention Type DEVICE

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

Interventions

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trifocal intraocular lens

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jin Yang

Role: STUDY_DIRECTOR

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

Locations

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Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Functional IOLs in cataracts

Identifier Type: -

Identifier Source: org_study_id

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