Phacoemulsification and Intraocular Lens Implantation: Patient Registry

Sensor Cliniq

Status: Enrolling

Conditions: Cataract; Intraocular Lens

Treatments: Device: Intraocular lens

Study type: Observational

Funder types: Other

Identifiers

NCT07276217

KB/1520/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Bilateral Monofocal IOL

Description:

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.

Treatment:

Device: Intraocular lens

Bilateral Monofocal-plus IOL

Description:

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.

Treatment:

Device: Intraocular lens

Bilateral EDOF IOL

Description:

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.

Treatment:

Device: Intraocular lens