Visual Performance of Functional Intraocular Lenses in Cataracts

Not Applicable

Active, not recruiting

• Conditions: High Myopia; Cataract
• Interventions: Device: trifocal intraocular lens

• Registration Number: NCT05581888
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

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 Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-06-30
• Study First Submitted: 2022-09-19
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-03
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TFNT00 group	trifocal intraocular lens	Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens.
839MP group	trifocal intraocular lens	Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens.

Primary Outcome Measures

Name	Time	Method
best corrected distance visual acuity (BCVA)	one year	corrected visual acuity at 5 m
uncorrected intermediate visual acuity (UIVA)	one year	uncorrected visual acuity at 60 cm
uncorrected near visual acuity (UNVA)	one year	uncorrected visual acuity at 40 cm
uncorrected distance visual acuity (UDVA)	one year	uncorrected visual acuity at 5 m

Secondary Outcome Measures

Name	Time	Method
objective visual quality	three months	MTF curves
HOAs	three months	high order aberrations such as coma
Strehl Ratio	three months	The derivative of point spread function (PSF)

Trial Locations

Locations (1)

Eye & ENT Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China