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CompletedNCT04907955Updated Jun 1, 2021

Visual Performance Following Implantation of Presbyopia Correcting IOLs

An interventional study of phacoemulsification with implantation of presbyopia correcting IOL in Loss of Visual Contrast Sensitivity, Near Vision and Visual Impairment, sponsored by Dar Al Shifa Hospital. Completed at 1 site in Kuwait. Per ClinicalTrials.gov, last updated 2021-06-01.

Sponsored by Dar Al Shifa Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jun 2019, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Loss of Visual Contrast Sensitivity
  • Near Vision
  • Visual Impairment
03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 50 is below the median of 78 across 923 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Dar Al Shifa Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with normal ocular examination apart from cataract.

Exclusion criteria

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Procedurephacoemulsification with implantation of presbyopia correcting IOL

    cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL

06

What researchers measure

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.

    Time frame: 6 months postoperatively.

Secondary outcomes

  1. 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.

    Time frame: 6 months postoperatively.

  2. 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.

    Time frame: 6 months postoperatively.

  3. photic phenomena

    The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.

    Time frame: 6 months postoperatively.

  4. spectacle independence

    patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.

    Time frame: 6 months postoperatively.

07

Study locations

1 site
  • Daralshifa hospital
    Kuwait, Kuwait
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04907955
Lead sponsor
Dar Al Shifa Hospital
Responsible party
magda torky (Principle investigator, Dar Al Shifa Hospital) — Principal investigator
First posted
Jun 1, 2021
Start date
Jun 1, 2019
Primary completion
May 30, 2020
Completion
May 30, 2020
Last update
Jun 1, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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