Visual Performance of Functional Intraocular Lenses in Cataracts

Study Overview
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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.

Official Title
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Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients

Conditions
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High Myopia, Cataract

Intervention / Treatment
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* Device: trifocal intraocular lens


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOAs | high order aberrations such as coma | three months | 
| Strehl Ratio | The derivative of point spread function (PSF) | three months | 
| objective visual quality | MTF curves | three months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual performance, Trifocal IOL, High myopic cataract