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

NCT07696130 | Recruiting

• 1 other identifier: enVista Envy
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Binocular contrast sensitivity.

  Preoperatively and at 1, 3, and 6 months postoperatively.

• Quality of vision and Near vision-related quality of life assessed using Questionnaires

  At 1, 3, and 6 months postoperatively.

• Incidence and severity of photic phenomena.

  At 1, 3, and 6 months postoperatively.

• Spectacle independence.

  At 1, 3, and 6 months postoperatively.

Study Arms (1)

20 patients (40 eyes)

EXPERIMENTAL

Patients who meet all inclusion criteria and none of the exclusion criteria.

Device: cataract surgery

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.

20 patients (40 eyes)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

II Department of Ophthalmology, Pomeranian Medical University

Szczecin, Zachodnipomorskie, 70-111, Poland

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Wojciech Lubiński

CONTACT

+48 91 466 12 93; oko@pum.edu.pl

Zuzanna Warenik

CONTACT

+48 91 466 12 93; z.warenik@usk2.szczecin.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Twenty patients will be selected according to predefined inclusion and exclusion criteria.

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: July 10, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)