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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05431868
Other study ID # Trifocal&AL
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information

Verified date June 2022
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date December 31, 2021
Est. primary completion date January 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Refractive Outcomes Manifest refraction was measured. Three months after surgery.
Primary Visual Acuity at Different Distances 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. Three months after surgery.
Primary Defocus Curve The defocus curve was measured with the additional spherical diopters from +2.00 D to -4.00 D in 0.50 D steps. Three months after surgery.
Primary Contrast Sensitivity and Aberrations 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. Three months after surgery.
Primary IOL decentration 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. Three months after surgery.
Primary Subjective Satisfaction 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. Three months after surgery.
Primary Life Quality The life quality after surgery was assessed by the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) in Chinese. Three months after surgery.
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