Objective and Subjective Outcomes of a Trifocal IOL in Eyes With Different AL

Completed

• Conditions: Cataract; Myopia; Lenses, Intraocular; Presbyopia; Satisfaction
• Interventions: Other: AT LISA tri 839MP (Carl Zeiss Meditec AG)

• Registration Number: NCT05431868
• Lead Sponsor: Peking University Third Hospital

Brief Summary

This prospective cohort study enrolled patients with implantation of a trifocal IOL. Only one eye of each patient was enrolled. Eyes were devided into three groups according the axial length (AL), including the short AL group, the control group and the long AL group. Manifest refraction, uncorrected and distance-corrected visual acuity at different distances, contrast sensitivity, aberrations and IOL decentration were measured three months after surgery. Spectacle independence, adverse photic phenomena, overall satisfaction and life quality were assessed with a questionnaire.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-12-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-20
• Study First Submitted QC: 2022-06-20
• Last Update Submitted: 2022-06-20
• Study First Posted: 2022-06-24
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Inclusion criteria were patients older than 40 years with significant bilateral or unilateral cataract seeking spectacle independence, with the AL between 21.00 to 30.00 mm, the prediction of postoperative corneal astigmatism less than 1.0 diopters (D), the angle kappa less than 0.50 mm, the corneal spherical aberration less than 0.5 μm and the corneal higher order aberration less than 0.5 μm.

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Exclusion Criteria

• Exclusion criteria were eyes with serious intraoperative complications, irregular corneal astigmatism, corneal scarring, uveitis, glaucoma, pseudoexfoliation syndrome, macular degeneration or other retinal impairment, amblyopia or patients having difficulties with examinations or 3 months' follow-up.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the control group	AT LISA tri 839MP (Carl Zeiss Meditec AG)	Eyes with AL between 22.50 to 25.50 mm were devided into the control group.
the long AL group	AT LISA tri 839MP (Carl Zeiss Meditec AG)	Eyes with AL more than 25.50 mm were devided into the long AL group.
the short AL group	AT LISA tri 839MP (Carl Zeiss Meditec AG)	Eyes with AL less than 22.50 mm were devided into the short AL group.

Primary Outcome Measures

Name	Time	Method
Contrast Sensitivity and Aberrations	Three months after surgery.	Using the OPTEC 6500 Vision Tester (Stereo Optical Co. Inc, Chicago, USA), the contrast sensitivity was conducted under four conditions, including photopic(85 cd/m2), mesopic(3 cd/m2), photopic with glare and mesopic with glare. Besides, there are five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree \[cpd\]) under every condition.
Visual Acuity at Different Distances	Three months after surgery.	Uncorrected and corrected distance (5 m) visual acuity (UDVA, CDVA), uncorrected and distance-corrected intermediate (80 cm) and near (40 cm) visual acuity (UIVA, DCIVA, UNVA and DCNVA) were measured.
Subjective Satisfaction	Three months after surgery.	The subjective satisfaction was assessed by a self-made questionnaire, which evaluated the spectacle independence at different distances, the incidence of several adverse photic phenomena including glare, halo and starburst, and the overall satisfaction.
Refractive Outcomes	Three months after surgery.	Manifest refraction was measured.
Defocus Curve	Three months after surgery.	The defocus curve was measured with the additional spherical diopters from +2.00 D to -4.00 D in 0.50 D steps.
IOL decentration	Three months after surgery.	OPD Scan-III (NIDEK, Inc.) can automatically recognize and locate the edge of the pupil and measure its position relative to the optic axis. After pupil dilation, the IOL decentration was measured through adjusting the edge of the pupil to the edge of the lens manually.
Life Quality	Three months after surgery.	The life quality after surgery was assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in Chinese.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China