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

NCT05431868 | Completed

• 1 other identifier: Trifocal&AL
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract; Presbyopia; Lenses, Intraocular; Myopia; Satisfaction

Keywords

Cataract; Presbyopia; Intraocular Lens; Axial Length; Satisfaction

Outcome Measures

Primary Outcomes (7)

• Refractive Outcomes

  Manifest refraction was measured.

  Three months after surgery.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (3)

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)

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)

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)

Interventions

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.

the control group; the long AL group; the short AL group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective cohort study collected data of patients who underwent bilateral or unilateral cataract surgery with the AT LISA tri 839MP implantation at the Department of Ophthalmology, Peking University Third Hospital, Beijing, China.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Cataract; Presbyopia; Myopia; Personal Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: January 1, 2019
• Primary Completion: January 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

CN (1)