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

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.

Study Overview

• Status: Recruiting
• Conditions: Cataract; Cataract (Post-operative Cataract Surgery Follow-up)
• Intervention / Treatment: Device: cataract surgery

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wojciech Lubiński; Phone Number: +48 91 466 12 93; Email: oko@pum.edu.pl
• Study Contact Backup: Name: Zuzanna Warenik; Phone Number: +48 91 466 12 93; Email: z.warenik@usk2.szczecin.pl

Study Locations

• Poland
  • Zachodnipomorskie
    • Szczecin, Zachodnipomorskie, Poland, 70-111
      • Recruiting
      • II Department of Ophthalmology, Pomeranian Medical University
      • Contact: Wojciech Lubiński; Phone Number: +48 91466 12 93; Email: oko@pum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Bilateral cataract or refractive lens exchange candidates.
• Presbyopia and/or hyperopia.
• Preoperative corneal astigmatism less than 1.00 diopter (D).
• Absence of ocular diseases other than cataract.
• High motivation to achieve spectacle independence.
• Patients willing to accept the possibility of mild photic phenomena, such as glare and halos.

Exclusion Criteria:

• Ocular Conditions:

  • Glaucoma.
  • Amblyopia.
  • Macular diseases (including macular degeneration and other macular pathology).
  • Angle kappa greater than 0.5 mm.
  • Dry eye disease.
  • Corneal disorders.
  • Pupil abnormalities.
  • Irregular astigmatism.
  • Ocular motility disorders or strabismus.
  • Pupil diameter < 2.5 mm under photopic conditions or > 6.0 mm under mesopic conditions.
  • Abnormalities of the capsular bag or zonular apparatus, including pseudoexfoliation syndrome (PEX).

• Lifestyle Factors:

  • Patients with unrealistic expectations regarding postoperative visual outcomes.
  • Individuals whose professions require highly precise visual performance, such as pilots, professional drivers, architects, or similar occupations.
  • Patients satisfied with using spectacles for near vision.
  • Age greater than 75 years (due to potential difficulties with neuroadaptation to new visual conditions).

• Psychological and Personality Factors:

  • Patients with psychiatric disorders that may interfere with study participation or outcome assessment.
  • Patients dissatisfied with progressive addition lenses (progressive spectacles).
  • Patients with dyslexia or a history of stroke.
  • Type A personality traits (perfectionists).
• Patients will also be excluded if the calculated IOL power falls outside the available range of +6.00 D to +34.00 D or if they have a history of laser vision correction surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 20 patients (40 eyes); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	From surgery to 6 months postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular contrast sensitivity.	Assessment of binocular contrast sensitivity under photopic and mesopic conditions.	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).	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.	At 1, 3, and 6 months postoperatively.
Spectacle independence.	Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.	At 1, 3, and 6 months postoperatively.

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: June 24, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Surgical Procedures, Operative; Ophthalmologic Surgical Procedures; Refractive Surgical Procedures; Cataract Extraction
• Other Study ID Numbers: enVista Envy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No