Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses

Sponsor
Pomeranian Medical University Szczecin
Study ID
NCT07696130
Status
Recruiting
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Conditions

  • Cataract
  • Cataract (Post-operative Cataract Surgery Follow-up)

Eligibility Criteria

Sex
ALL
Age
50 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • cataract surgery — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 10, 2026
Start date
Feb 1, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 20 patients (40 eyes)
    Patients who meet all inclusion criteria and none of the exclusion criteria.

Primary Outcome Measure

Visual function at distance, intermediate, and near ranges. [ Time Frame: Preoperatively and at 1, 3, and 6 months postoperatively. ]

Central Contacts

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