CataractNCT07276217
Phacoemulsification and Intraocular Lens Implantation: Patient Registry
An observational study of Cataract and Intraocular Lens, run by Sensor Cliniq at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Intraocular Lens
- What is being tested?
- Intraocular lens
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jan 2025to Jul 2026
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Posterior capsule opacification
- Postoperative best-corrected visual acuity (BCVA) less 0.5
- Intraoperative complications, including posterior capsule rupture
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Sensor Cliniq
Warsaw
Jakub Polinski, Medical Doctor, +48227103333, szpital@sensorcliniq.pl
About this study
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.
Read the 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.
- Conditions
- Cataract, Intraocular Lens
- Being tested
- Intraocular lens
- Keywords
- cataract, intraocular lens, phacoemulsification
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraocular lensDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Intraocular lens | |
| 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. Receives: Device: Intraocular lens | |
| 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. Receives: Device: Intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at the follow-up visit up to 60 months after cataract surgery
Secondary outcomes (12)
Objective Refraction
Spherical and cylindrical refractive errors will be measured objectively using an autorefractometer.
Measured: Measured at the follow-up visit up to 60 months after cataract surgery
Subjective Refraction
Spherical and cylindrical refractive errors will be measured subjectively using trial frame glasses and patient responses.
Measured: 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: 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: Measured at the follow-up visit up to 60 months after cataract surgery
Keratometry
Keratometry will be measured using IOLMaster 500 and Pentacam
Measured: 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: 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: 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: 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: 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: 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: 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: Measured at the follow-up visit up to 60 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start2 Jan 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Sensor Cliniq
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakub Polinski, Sensor Cliniq
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276217
- Sponsor's protocol ID
- KB/1520/24
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phacoemulsification and Intraocular Lens Implantation: Patient Registry
- ClinicalTrials.gov ID
- NCT07276217
- Acronym / sponsor ID
- KB/1520/24
- Conditions
- Cataract, Intraocular Lens
- Keywords
- cataract, intraocular lens, phacoemulsification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sensor CliniqUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Monofocal IOL | – | Device: Intraocular lensPatients who underwent bilateral cataract surgery with implantation of monofocal intraocular lenses in both eyes between 2021 and 2025, and attended a follow-up visit. |
| Bilateral Monofocal-plus IOL | – | Device: Intraocular lensPatients 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. |
| Bilateral EDOF IOL | – | Device: Intraocular lensPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraocular lensImplantation 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). | Device | Bilateral EDOF IOL, Bilateral Monofocal IOL, Bilateral Monofocal-plus IOL |
Primary outcome
Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity
Time frame: 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.
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Intraocular Lens, run by Sensor Cliniq at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corrected and Uncorrected Distance, Intermediate and Near Visual Acuity (time frame: Measured at the follow-up visit up to 60 months after cataract surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.