Visual Performance Following Implantation of Presbyopia Correcting IOLs

Study Overview
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Brief Summary
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The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.

Official Title
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Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses

Conditions
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Near Vision, Loss of Visual Contrast Sensitivity, Visual Impairment

Intervention / Treatment
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* Procedure: phacoemulsification with implantation of presbyopia correcting IOL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with normal ocular examination apart from cataract. Exclusion Criteria: previous ocular surgery. ocular pathology or corneal abnormalities. an endothelial cell count below 2000 cells/mm2. corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: panoptix PANFOCAL intraocular lens<br>panoptix PANFOCAL intraocular lensis a single-piece aspheric non-apodized diffractive panfocal IOL that distributes light energy to three focal points in both small and large pupil conditions | Procedure: phacoemulsification with implantation of presbyopia correcting IOL<br>* cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL<br>|
| Active Comparator: Trifocal Diffractive the AT LISA intraocular lens<br>Trifocal Diffractive the AT LISA is a preloaded single-piece aspheric diffractive trifocal IOL and made of hydrophilic acrylic with a hydrophobic surface with an ultraviolet absorber. This aspheric IOL is aberration -correcting in order to reduce and compensate for corneal spherical aberrations. | Procedure: phacoemulsification with implantation of presbyopia correcting IOL<br>* cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL<br>|
| Active Comparator: Symphony EDOF (extended depth of focus) intraocular lens<br>SYMPHONY EDOF intraocular lens is a single-piece aspheric biconvex hydrophobic acrylic IOL with a 6.0 mm optic and an 13.0 mm overall diameter. This IOL consists of a wavefront-designed anterior aspheric surface (negative spherical aberration of -0.27 mm to counterbalance the net positive spherical aberration from cornea) and a posterior achromatic diffractive surface with echelette design. | Procedure: phacoemulsification with implantation of presbyopia correcting IOL<br>* cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | The monocular uncorrected (UDVA) and corrected (CDVA) distance visual acuity (4 m), uncorrected intermediate visual acuity (UIVA) (60 cm and 80 cm), distance-corrected intermediate visual acuity (DCIVA), uncorrected near visual acuity (40 cm), and distance-corrected near visual acuity (DCNVA) were assessed. Standardized logarithm of the minimum angle of resolution (logMAR) charts were used for visual acuity measurement at 4 m, 80 cm, and 40 cm. | 6 months postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| defocus curve | The binocular defocus curve was done to evaluate the functional range of vision. The curve was obtained while the patient wearing his distance correction to provide the best distance visual acuity in both eyes. The test was performed under photopic conditions (85 candelas/m2) using ETDRS charts at a distance of 4m with the introduction of defocusing lenses from +1.00 D to -4.00 D in 0.50 D steps. | 6 months postoperatively. | 
| contract senstivity | The CSV-1000 system (Vector Vision Inc. Greenville, OH, USA) was used to measure contrast sensitivity under photopic and mesopic conditions without glare with spatial frequencies ranging between 3 and 18 cycles/degree. | 6 months postoperatively. | 
| photic phenomena | The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother. | 6 months postoperatively. | 
| spectacle independence | patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no. | 6 months postoperatively. |