Phacoemulsification and Intraocular Lens Implantation: Patient Registry

The aim of the study is to create a patient registry that will allow for comparison of cataract treatment outcomes using phacoemulsification with implantation of different types of intraocular lenses.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Intraocular Lens
• Intervention / Treatment: Device: Intraocular lens

Detailed Description

This study will establish a registry to evaluate outcomes associated with intraocular lens implants in patients undergoing cataract surgery. Retrospective assessments will include routinely collected preoperative, intraoperative, and postoperative data. Prospectively, visual acuity, refraction, examination findings, patient-reported outcomes, and complications will be collected for up to 60 months after surgery.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • Recruiting
    • Sensor Cliniq
    • Contact: Jakub Polinski, Medical Doctor; Phone Number: +48227103333; Email: szpital@sensorcliniq.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.

Description

Inclusion Criteria:

• Patients who have undergone cataract surgery or are scheduled for bilateral cataract surgery with implantation of an extended-depth-of-focus (EDOF) intraocular lens, a monofocal-plus intraocular lens, or a standard monofocal intraocular lens.

Exclusion Criteria:

• Anterior or posterior segment pathologies affecting postoperative visual acuity, including but not limited to: severe dry eye syndrome, corneal dystrophies, uveitis, retinal degenerative changes, glaucoma, or diabetic retinopathy.
• Pseudoexfoliation syndrome
• Keratoconus
• History of laser refractive surgery
• Prior ocular surgery other than cataract surgery
• Amblyopia
• Posterior capsule opacification
• Postoperative best-corrected visual acuity (BCVA) less 0.5
• Intraoperative complications, including posterior capsule rupture

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bilateral Monofocal IOL; Patients who underwent bilateral cataract surgery with implantation of monofocal intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.	Device: Intraocular lens; Implantation of an intraocular lens following phacoemulsification cataract extraction, with lens type selected according to routine clinical practice (e.g., monofocal, toric, multifocal, or extended-depth-of-focus).
Bilateral Monofocal-plus IOL; Patients who underwent bilateral cataract surgery with implantation of monofocal-plus intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.	Device: Intraocular lens; Implantation of an intraocular lens following phacoemulsification cataract extraction, with lens type selected according to routine clinical practice (e.g., monofocal, toric, multifocal, or extended-depth-of-focus).
Bilateral EDOF IOL; Patients who underwent bilateral cataract surgery with implantation of extended-depth-of-focus (EDOF) intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit.	Device: Intraocular lens; Implantation of an intraocular lens following phacoemulsification cataract extraction, with lens type selected according to routine clinical practice (e.g., monofocal, toric, multifocal, or extended-depth-of-focus).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity	Distance, intermediate, and near visual acuity will be measured both uncorrected and corrected using standard ETDRS charts at 4 meters for distance, 66 cm for intermediate, and 40 cm for near visual acuity.	Measured at the follow-up visit up to 60 months after cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Refraction	Spherical and cylindrical refractive errors will be measured objectively using an autorefractometer.	Measured at the follow-up visit up to 60 months after cataract surgery
Subjective Refraction	Spherical and cylindrical refractive errors will be measured subjectively using trial frame glasses and patient responses.	Measured at the follow-up visit up to 60 months after cataract surgery
Monocular and Binocular Defocus Curve	Visual acuity will be measured at varying defocus levels under monocular and binocular conditions to assess the range of functional vision. Measurements will be taken in 0.5 D steps from +1.00 D to -2.50 D.	Measured at the follow-up visit up to 60 months after cataract surgery
Contrast Sensitivity	Contrast sensitivity will be assessed using the Matrix Perceptix test under photopic light conditions.	Measured at the follow-up visit up to 60 months after cataract surgery
Keratometry	Keratometry will be measured using IOLMaster 500 and Pentacam	Measured at the follow-up visit up to 60 months after cataract surgery
Anterior Chamber Depth	Anterior chamber depth will be measured using IOLMaster 500 and Pentacam.	Measured at the follow-up visit up to 60 months after cataract surgery
Pupil Size	Pupil diameter will be measured using IOLMaster 500 and Pentacam.	Measured at the follow-up visit up to 60 months after cataract surgery
Central Corneal Thickness	Central corneal thickness will be measured using Pentacam.	Measured at the follow-up visit up to 60 months after cataract surgery
Anterior Chamber Angle	Anterior chamber angle will be measured using Pentacam.	Measured at the follow-up visit up to 60 months after cataract surgery
Primary and Secondary Spherical Aberrations	Primary and secondary spherical aberrations will be measured using Pentacam.	Measured at the follow-up visit up to 60 months after cataract surgery
Patient-Reported Spectacle Independence	Degree of spectacle independence will be assessed using the Patient-Reported Spectacle Independence Questionnaire (PRSIQ).	Measured at the follow-up visit up to 60 months after cataract surgery
Patient-Reported Quality of Vision	Quality of vision will be assessed using the Quality of Vision Questionnaire (QoV).	Measured at the follow-up visit up to 60 months after cataract surgery

Collaborators and Investigators

• Sponsor: Sensor Cliniq

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: November 28, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: phacoemulsification; cataract; intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Equipment and Supplies; Optical Devices; Prostheses and Implants; Lenses; Lenses, Intraocular
• Other Study ID Numbers: KB/1520/24