Phacoemulsification and Intraocular Lens Implantation: Patient Registry

NCT ID: NCT07276217

Last Updated: 2025-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-02

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cataract Intraocular Lens

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Intraocular lens

Intervention Type DEVICE

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.

Intraocular lens

Intervention Type DEVICE

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.

Intraocular lens

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sensor Cliniq

OTHER

Sponsor Role lead

Responsible Party

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Jakub Polinski

Ophthalmologist, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sensor Cliniq

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Facility Contacts

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Jakub Polinski, Medical Doctor

Role: primary

+48227103333

Other Identifiers

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KB/1520/24

Identifier Type: -

Identifier Source: org_study_id

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