Phacoemulsification and Intraocular Lens Implantation: Patient Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSensor Cliniq
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients who have undergone or are scheduled for bilateral cataract surgery at Sensor Cliniq between 2021 and 2025.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Intraocular lens
DeviceImplantation 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).
Treatment groups
300 Participants
are divided into 3 treatment groupsGroup A: Bilateral Monofocal IOL1 intervention
Group B: Bilateral Monofocal-plus IOL1 intervention
Group C: Bilateral EDOF IOL1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Measured at the follow-up visit up to 60 months after cataract surgerySecondary outcomes
1
Objective Refraction
Spherical and cylindrical refractive errors will be measured objectively using an autorefractometer.
Time frame
Measured at the follow-up visit up to 60 months after cataract surgery2
Subjective Refraction
Spherical and cylindrical refractive errors will be measured subjectively using trial frame glasses and patient responses.
Time frame
Measured at the follow-up visit up to 60 months after cataract surgery3
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.
Time frame
Measured at the follow-up visit up to 60 months after cataract surgery4
Contrast Sensitivity
Contrast sensitivity will be assessed using the Matrix Perceptix test under photopic light conditions.
Time frame
Measured at the follow-up visit up to 60 months after cataract surgerySponsors and contacts
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Source ClinicalTrials.gov