Back to resultsVisual Performance Following Implantation of Presbyopia Correcting IOLs
Primary Purpose
Loss of Visual Contrast Sensitivity, Near Vision, Visual Impairment
Status
Completed
Phase
Not Applicable
Locations
Kuwait
Study Type
Interventional
Intervention
phacoemulsification with implantation of presbyopia correcting IOL
Sponsored by
About this trial
This is an interventional treatment trial for Loss of Visual Contrast Sensitivity
Eligibility Criteria
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).
Sites / Locations
- Daralshifa hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
panoptix PANFOCAL intraocular lens
Trifocal Diffractive the AT LISA intraocular lens
Symphony EDOF (extended depth of focus) intraocular lens
Arm Description
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
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
photic phenomena
The presence of dysphotopsia including haloes, glare and starburst were assessed regarding their frequency, severity and the degree of bother.
spectacle independence
patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04907955
Brief Title
Visual Performance Following Implantation of Presbyopia Correcting IOLs
Official Title
Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 30, 2020 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dar Al Shifa Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Loss of Visual Contrast Sensitivity, Near Vision, Visual Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
panoptix PANFOCAL intraocular lens
Arm Type
Active Comparator
Arm Description
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
Arm Title
Trifocal Diffractive the AT LISA intraocular lens
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Symphony EDOF (extended depth of focus) intraocular lens
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
phacoemulsification with implantation of presbyopia correcting IOL
Intervention Description
cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
Primary Outcome Measure Information:
Title
visual acuity
Description
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 Outcome Measure Information:
Title
defocus curve
Description
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.
Title
contract senstivity
Description
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.
Title
photic phenomena
Description
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.
Title
spectacle independence
Description
patients were given a questionnaire to assess their spectacle independence. The response for spectacle independence was yes or no.
Time Frame
6 months postoperatively.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Daralshifa hospital
City
Kuwait
Country
Kuwait
12. IPD Sharing Statement
Plan to Share IPD
No
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Visual Performance Following Implantation of Presbyopia Correcting IOLs
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