Phacoemulsification and Intraocular Lens Implantation: Patient Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraocular lens.
- Who it may be relevant to
- Registry conditions: Cataract, Intraocular Lens. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- 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).
Primary outcome measures
- Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
Secondary outcome measures (12)
- Objective Refraction [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Subjective Refraction [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Monocular and Binocular Defocus Curve [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Contrast Sensitivity [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Keratometry [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Anterior Chamber Depth [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Pupil Size [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Central Corneal Thickness [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Anterior Chamber Angle [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Primary and Secondary Spherical Aberrations [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Patient-Reported Spectacle Independence [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
- Patient-Reported Quality of Vision [Time frame: Measured at the follow-up visit up to 60 months after cataract surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Poland · 1 center
- Sensor Cliniq — Warsaw
Identifiers
NCT: NCT07276217 · KB/1520/24