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

Sponsor

Peking University Third Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05431868

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract Presbyopia Lenses, Intraocular Myopia Satisfaction	Other: AT LISA tri 839MP (Carl Zeiss Meditec AG)

Study Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Presbyopia-correcting Performance and Subjective Outcomes of a Trifocal Intraocular Lens in Eyes With Different Axial Lengths: a Prospective Cohort Study

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
the short AL group Eyes with AL less than 22.50 mm were devided into the short AL group.	Other: AT LISA tri 839MP (Carl Zeiss Meditec AG) This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.
the control group Eyes with AL between 22.50 to 25.50 mm were devided into the control group.	Other: AT LISA tri 839MP (Carl Zeiss Meditec AG) This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.
the long AL group Eyes with AL more than 25.50 mm were devided into the long AL group.	Other: AT LISA tri 839MP (Carl Zeiss Meditec AG) This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.

Arm

Intervention/Treatment

the short AL group

Eyes with AL less than 22.50 mm were devided into the short AL group.

Other: AT LISA tri 839MP (Carl Zeiss Meditec AG)

This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.

the control group

Eyes with AL between 22.50 to 25.50 mm were devided into the control group.

Other: AT LISA tri 839MP (Carl Zeiss Meditec AG)

This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.

the long AL group

Eyes with AL more than 25.50 mm were devided into the long AL group.

Other: AT LISA tri 839MP (Carl Zeiss Meditec AG)

This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation.

Outcome Measures

Primary Outcome Measures

Refractive Outcomes [Three months after surgery.]
Manifest refraction was measured.
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.
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.
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.
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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

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.