CataractNCT07696130
Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses
A study testing cataract surgery in people with Cataract and Cataract (Post-operative Cataract Surgery Follow-up), run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Cataract, Cataract (Post-operative Cataract Surgery Follow-up)
- What is being tested?
- cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Ocular Conditions:
- Glaucoma.
- Amblyopia.
- Macular diseases (including macular degeneration and other macular pathology).
- Angle kappa greater than 0.5 mm.
- Dry eye disease.
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
II Department of Ophthalmology, Pomeranian Medical University
Szczecin, Zachodnipomorskie, 70-111
Wojciech Lubiński, +48 91466 12 93, oko@pum.edu.pl
About this study
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.
Read more
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.
- Being tested
- cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDevice
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 group | Role | What they receive |
|---|---|---|
| 20 patients (40 eyes) | Experimental | Patients who meet all inclusion criteria and none of the exclusion criteria. Receives: Device: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From surgery to 6 months postoperatively.
Secondary outcomes (4)
Binocular contrast sensitivity.
Assessment of binocular contrast sensitivity under photopic and mesopic conditions.
Measured: 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).
Measured: 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.
Measured: At 1, 3, and 6 months postoperatively.
Spectacle independence.
Assessment of participants' need for spectacles for distance, intermediate, and near vision tasks.
Measured: At 1, 3, and 6 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Feb 2026
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Twenty patients will be selected according to predefined inclusion and exclusion criteria.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696130
- Sponsor's protocol ID
- enVista Envy
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Outcomes, Complications, and Neuroadaptation Following Bilateral Implantation of enVista Envy Trifocal Intraocular Lenses
- ClinicalTrials.gov ID
- NCT07696130
- Acronym / sponsor ID
- enVista Envy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Twenty patients will be selected according to predefined inclusion and exclusion criteria.
| Arm | Type | Receives |
|---|---|---|
| 20 patients (40 eyes) | Experimental | Device: cataract surgeryPatients who meet all inclusion criteria and none of the exclusion criteria. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (23 listed)
- Ocular Conditions:
- Lifestyle Factors:
- Psychological and Personality Factors:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgerySurgery 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. | Device | 20 patients (40 eyes) |
Primary outcome
Visual function at distance, intermediate, and near ranges.
Time frame: Preoperatively and at 1, 3, and 6 months postoperatively.
Improvement in visual function at distance (4 m), intermediate (66 cm), and near (40 cm) distances following bilateral implantation of the enVista Envy IOL.
Neuroadaptation time.
Time frame: From surgery to 6 months postoperatively.
Reduction in the time required for neuroadaptation following bilateral implantation of the enVista Envy IOL.
Intraoperative and postoperative complications.
Time frame: From surgery to 6 months postoperatively.
Assessment of adverse events and complications associated with cataract surgery and implantation of the enVista Envy IOL.
4 secondary outcomes
Binocular contrast sensitivity.
Time frame: Preoperatively and at 1, 3, and 6 months postoperatively.
Quality of vision and Near vision-related quality of life assessed using Questionnaires
Time frame: At 1, 3, and 6 months postoperatively.
Incidence and severity of photic phenomena.
Time frame: At 1, 3, and 6 months postoperatively.
Spectacle independence.
Time frame: At 1, 3, and 6 months postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract and Cataract (Post-operative Cataract Surgery Follow-up), run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Lubiński (+48 91 466 12 93, oko@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual function at distance, intermediate, and near ranges. (time frame: Preoperatively and at 1, 3, and 6 months postoperatively.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.