Cataract, Intraocular Lens
Conditions
Keywords
cataract, intraocular lens, phacoemulsification
Brief summary
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
DEVICEIntraocular 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).
Sponsors
Sensor Cliniq
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity | Measured at the follow-up visit up to 60 months after cataract surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Refraction | Measured at the follow-up visit up to 60 months after cataract surgery | Spherical and cylindrical refractive errors will be measured subjectively using trial frame glasses and patient responses. |
| Monocular and Binocular Defocus Curve | Measured at the follow-up visit up to 60 months after cataract surgery | 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. |
| Contrast Sensitivity | Measured at the follow-up visit up to 60 months after cataract surgery | Contrast sensitivity will be assessed using the Matrix Perceptix test under photopic light conditions. |
| Keratometry | Measured at the follow-up visit up to 60 months after cataract surgery | Keratometry will be measured using IOLMaster 500 and Pentacam |
| Anterior Chamber Depth | Measured at the follow-up visit up to 60 months after cataract surgery | Anterior chamber depth will be measured using IOLMaster 500 and Pentacam. |
| Objective Refraction | Measured at the follow-up visit up to 60 months after cataract surgery | Spherical and cylindrical refractive errors will be measured objectively using an autorefractometer. |
| Central Corneal Thickness | Measured at the follow-up visit up to 60 months after cataract surgery | Central corneal thickness will be measured using Pentacam. |
| Anterior Chamber Angle | Measured at the follow-up visit up to 60 months after cataract surgery | Anterior chamber angle will be measured using Pentacam. |
| Primary and Secondary Spherical Aberrations | Measured at the follow-up visit up to 60 months after cataract surgery | Primary and secondary spherical aberrations will be measured using Pentacam. |
| Patient-Reported Spectacle Independence | Measured at the follow-up visit up to 60 months after cataract surgery | Degree of spectacle independence will be assessed using the Patient-Reported Spectacle Independence Questionnaire (PRSIQ). |
| Patient-Reported Quality of Vision | Measured at the follow-up visit up to 60 months after cataract surgery | Quality of vision will be assessed using the Quality of Vision Questionnaire (QoV). |
| Pupil Size | Measured at the follow-up visit up to 60 months after cataract surgery | Pupil diameter will be measured using IOLMaster 500 and Pentacam. |
Countries
Poland
Outcome results
None listed