An interventional study of cataract surgery in Cataract and Cataract (Post-operative Cataract Surgery Follow-up), sponsored by Pomeranian Medical University Szczecin. Recruiting at 1 site in Poland. Open to participants aged 50 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Pomeranian Medical University Szczecin · Not applicable, Interventional, and Treatment
The enVista Envy intraocular lens (IOL) manufactured by Bausch + Lomb is a new multifocal intraocular lens based on diffractive optics. It was registered with the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in September 2025. The lens also bears the CE mark, indicating that it is approved for marketing and use within the European Union.
Its innovative design is based on a smooth, continuous transition between diffractive rings, allowing patients to achieve excellent visual quality at far, intermediate, and near distances while reducing the incidence and severity of unwanted photic phenomena such as glare and halos. Thanks to this technology, patients may achieve better uncorrected visual acuity, reduced dependence on spectacles, and faster neuroadaptation.
The Second Department of Ophthalmology is the first center in Poland to be offered participation in a clinical study evaluating the safety and effectiveness of the enVista Envy IOL. The planned study will provide the first clinical experience with this lens in Poland and contribute to expanding knowledge regarding modern intraocular lens technologies.
Twenty patients will be selected according to predefined inclusion and exclusion criteria. Preoperative assessment will include a comprehensive ophthalmic examination and IOL power calculation. Cataract surgery will be performed using bimanual MICS (Micro-Incision Cataract Surgery) phacoemulsification. Surgery in the fellow eye will be performed one month after the first procedure.
Before surgery and during follow-up visits at 1, 3, and 6 months postoperatively, the following assessments will be performed: routine ophthalmic examination, intraocular pressure (IOP) measurement, visual evoked potentials (VEP), monocular and binocular uncorrected distance visual acuity (UDVA), distance best-corrected visual acuity (DBCVA) at 4 meters, intermediate visual acuity (66 cm) and near visual acuity (40 cm), both corrected and uncorrected, monocularly and binocularly (logMAR charts), binocular contrast sensitivity testing, and defocus curve assessment.
Intraoperative and postoperative complications, quality of vision (using the standardized Quality of Vision Questionnaire [QoV] and the Near Activity Vision Questionnaire [NAVQ]), speed of neuroadaptation, spectacle independence, and the occurrence of photic phenomena such as glare and halos will also be analyzed.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 20 is below the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →Pomeranian Medical University Szczecin is the lead sponsor of 69 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Ocular Conditions:
Lifestyle Factors:
Psychological and Personality Factors:
Patients who meet all inclusion criteria and none of the exclusion criteria.
Device: cataract surgery
Surgery performed using the NGENUITY® 3D Visualization System. Two-handed Micro-Incision Cataract Surgery (MICS) technique. Corneal incisions measuring 1.2 × 1.4 mm at the 2 o'clock and 10 o'clock positions. Continuous curvilinear capsulorhexis with a diameter of approximately 5 mm. Ultrasound phacoemulsification. Intraocular lens (IOL) implantation through a 2.2-2.3 mm incision. The implanted intraocular lens (IOL) will be the enVista Envy IOL.
Visual function at distance, intermediate, and near ranges.
Improvement in visual function at distance (4 m), intermediate (66 cm), and near (40 cm) distances following bilateral implantation of the enVista Envy IOL.
Time frame: Preoperatively and at 1, 3, and 6 months postoperatively.
Neuroadaptation time.
Reduction in the time required for neuroadaptation following bilateral implantation of the enVista Envy IOL.
Time frame: From surgery to 6 months postoperatively.
Intraoperative and postoperative complications.
Assessment of adverse events and complications associated with cataract surgery and implantation of the enVista Envy IOL.
Time frame: From surgery to 6 months postoperatively.
Binocular contrast sensitivity.
Assessment of binocular contrast sensitivity under photopic and mesopic conditions.
Time frame: Preoperatively and at 1, 3, and 6 months postoperatively.
Quality of vision and Near vision-related quality of life assessed using Questionnaires
Evaluation of subjective visual quality, including frequency, severity, and bothersomeness of visual disturbances - Quality of Vision (QoV) Questionnaire. Evaluation of patient-reported ability to perform near-vision activities and overall satisfaction with near vision - The Near Activity Visual Questionnaire (NAVQ).
Time frame: At 1, 3, and 6 months postoperatively.
Incidence and severity of photic phenomena.
Assessment of the occurrence and severity of photic phenomena reported by participants.
Time frame: At 1, 3, and 6 months postoperatively.
Spectacle independence.
Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.
Time frame: At 1, 3, and 6 months postoperatively.
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Feb 2029, 36 months after the start.
Of 300 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 36 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
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Pomeranian Medical University Szczecin