Visual Outcomes and Contrast Sensitivity in Patients Implanted With Tecnis Eyhance Intraocular Lens
Condition: Intraocular Lens
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      To compare visual outcomes for various distances, reading speed, contrast sensitivity, glare
      occurence, defocus curve and subjective satisfaction in patients implanted with the extended
      depth of focus lens (Tecnis Eyhance) in one eye and monocal aspheric lens (Tecnis ZCB00) in
      second eye. Patients undergo visit in 3,6 and 12 months after the surgery.
    

Detailed description: 
      The goal of refractive cataract surgery is to remove the opacity, or cataract and to produce
      the desired refractive outcome. In most cases, the desired outcome is an emmetropic eye, or
      an eye that sees 20/20 Snellen for distance vision post-surgery with the implant of a
      monofocal IOL. This, however, does not offer much in the way of intermediate and near vision.
      The increased desire for simultaneous distance, intermediate and near vision has increased
      the popularity of multifocal IOLs (MIOLs). However MIOLs provide visual acuity for all
      distances, they has occurence of optical phenomena such as glare and halo and lower contrast
      sensitivity. Extended depth of focus (EDOF) lens should provide distance vision as good as
      monofocal lens and intermediate vision better than monofocal but without any optical
      phenomenon or decreased contrast sensitivity.

      This study is conducted from 11/2019 to 08/2021 in the Ophthalmology department of Faculty
      Hospital Kralovske Vinohrady in Prague. The research protocol was explained to all
      participants and informed consent was signed before enrolling patient to the study. The study
      was approved by the Ethics Committee of Faculty Hospital Kralovske Vinohrady and will
      enrolled up to 25 patients with presence of cataract in both eyes.

      Bilateral clear corneal phacoemulsification and IOL implantation is performed by one surgeon
      using the same technique in both eyes. The surgical process involved topical anesthesia,
      superior 3-step clear corneal incision (2,2mm), 5,0mm curvilinear capsulorhexis,
      phacoemulsification, bilateral irrigation- aspiration and IOL implantation. One eye is
      implanted with EDOF IOL second eye with monofocal IOL. Type of IOL is chosen randomly and
      double masked.

      Patients are scheduled for visit at 3,6 and 12 months after the surgery.
    

Intervention name(s): TECNIS Eyhance intraocular lens; Monofocal intraocular lens Tecnis ZCB00
Intervention type(s): Device; Device
Intervention description(s): Cataract surgery and implantation with extended depth of focus intraocular lens; Cataract surgery and implantation with monofocal intraocular lens
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: each patient in group received monofocal intraocular lens in one eye and extended depth of focus intraocular lens in second eye
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: EDOF lens; Cataract