NCT04907955

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

May 21, 2021

Last Update Submit

May 25, 2021

Conditions

Loss of Visual Contrast SensitivityNear VisionVisual Impairment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • defocus curve

    6 months postoperatively.

  • contract senstivity

    6 months postoperatively.

  • photic phenomena

    6 months postoperatively.

  • spectacle independence

    6 months postoperatively.

Study Arms (3)

panoptix PANFOCAL intraocular lens

ACTIVE COMPARATOR

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

Trifocal Diffractive the AT LISA intraocular lens

ACTIVE COMPARATOR

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

Symphony EDOF (extended depth of focus) intraocular lens

ACTIVE COMPARATOR

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

Interventions

phacoemulsification with implantation of presbyopia correcting IOLPROCEDURE

cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

Symphony EDOF (extended depth of focus) intraocular lensTrifocal Diffractive the AT LISA intraocular lenspanoptix PANFOCAL intraocular lens

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with normal ocular examination apart from cataract.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daralshifa hospital

Kuwait City, Kuwait

Location

MeSH Terms

Conditions

MyopiaVision Disorders

Interventions

Phacoemulsification

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cataract ExtractionRefractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeUltrasonic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

May 21, 2021

First Posted

June 1, 2021

Study Start

June 1, 2019

Primary Completion

May 30, 2020

Study Completion

May 30, 2020

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

KU(1)