Visual Performance Following Implantation of Presbyopia Correcting IOLs

Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses

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.

Study Overview

• Status: Completed
• Conditions: Visual Impairment; Loss of Visual Contrast Sensitivity; Near Vision
• Intervention / Treatment: Procedure: phacoemulsification with implantation of presbyopia correcting IOL

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kuwait
  • Kuwait, Kuwait
    • Daralshifa hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: panoptix PANFOCAL intraocular lens; 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; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
Active Comparator: Trifocal Diffractive the AT LISA intraocular lens; 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; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
Active Comparator: Symphony EDOF (extended depth of focus) intraocular lens; 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; cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Dar Al Shifa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): May 30, 2020

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Refractive Errors; Presbyopia; Vision, Low; Vision Disorders
• Other Study ID Numbers: 02282021065727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No