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Completed

NCT Number: NCT05431868

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

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.

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Key information

Conditions

Cataract Behavior Eye Diseases Lens Diseases Lenses, Intraocular Myopia Personal Satisfaction Presbyopia Refractive Errors Satisfaction

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AT LISA tri 839MP (Carl Zeiss Meditec AG)

Other

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

Primary outcomes

  1. Refractive Outcomes

    Time frame: Three months after surgery.

    Manifest refraction was measured.

  2. Visual Acuity at Different Distances

    Time frame: 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.

  3. Defocus Curve

    Time frame: 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.

  4. Contrast Sensitivity and Aberrations

    Time frame: 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.

  5. IOL decentration

    Time frame: 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.

  6. Subjective Satisfaction

    Time frame: 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.

  7. Life Quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 24, 2022
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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