Bilateral Implantation of enVista Envy Trifocal IOL for Cataract Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the safety and effectiveness of the enVista Envy trifocal intraocular lens implanted in both eyes during cataract or refractive lens exchange procedures. It focuses on visual outcomes, potential complications, and how patients adapt to the new lens. Eligible participants have bilateral cataracts or prior refractive lens replacement, minimal corneal astigmatism, and a strong desire for spectacle independence. Exclusion criteria include several ocular diseases and conditions that could affect vision or lens performance. The study is led by Pomeranian Medical University Szczecin and is based at the II Department of Ophthalmology in Szczecin, Poland.

Why it matters

Who can join: the full rules

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.

Where it's running

• II Department of Ophthalmology, Pomeranian Medical University
  Szczecin, Zachodnipomorskie, Poland Recruiting

Study contacts

• Study coordinator: Wojciech Lubiński
• Email: oko@pum.edu.pl
• Phone: +48 91 466 12 93

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.