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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular lens | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sensor Cliniq | Recruiting | Warsaw | Poland |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D007910 | Lenses, Intraocular |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D019736 | Prostheses and Implants |
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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 |