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Comparison of Visual Performance of Four Types of Multifocal Intraocular Lenses (presbyopia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03454334
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2018
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):
farinaz doroodgar, Shahid Beheshti University

Brief Summary:
This investigation assessed the visual performance of presbyopia and cataract patients after bilateral implantation of 4 distinct sorts of multifocal IOLs: At lisa tri, PanOptix, ReSTOR, and Symfony. The clinical results demonstrated here were excellent for four groups, however, there were also differences in group ReSTOR, UCVA and BCVA for the intermediate and near of the other groups showed less vision also symphony group for far distance demonstrated less vision than other groups, which may be related to their design.Multifocal IOLs demonstrated very good technology and unquestionably have a place in refractive surgery, whether for clear lens extraction or cataracts.Patients can expect excellent outcomes and surgeons can expect patients to be very satisfied with surgical outcomes. Four groups multifocal lenses provided excellent distance, intermediate and near vision, but several measures indicated that the PanOptix and at lisa tri lens provided better vision in all distances. Spectacle independence was significantly higher with four groups. Multifocal IOL design might play a role in the postsurgical outcome, because better results were obtained with diffractive lenses. Although there were differences in the results of these four lenses in the study, all of the results were acceptable.

Condition or disease Intervention/treatment Phase
Cataract Device: multifocal intraocular lens IOLs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts
Actual Study Start Date : February 11, 2013
Estimated Primary Completion Date : October 18, 2018
Estimated Study Completion Date : December 14, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: AMO Tecnis Symfony

Multifocal with extended range of vision, Diffractive, No Preloaded, Aspheric, +3.25 D near add and +2.17 D intermediate 6.0mm Hydrophilic


Has nine diffractive steps, The proprietary achromatic technology corrects chromatic aberration. This creates improved contrast sensitivity.

Device: multifocal intraocular lens IOLs
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts

Active Comparator: AcrySof ReSTOR (Alcon Laboratories)

Multifocal ,Diffractive, +3.00D and for Near, Aspheric, Has 9 steps (rings), Light: 41% for far; 41% for near: 18% reflected (lost).

6.0mm Silicone

-0.10 Bifocal ,One piece,Blue filter ,Central diffractive region of 3.6_mm for near and distance vision ,Apodised ,peripheral refractive region is dedicated to distance vision

Device: multifocal intraocular lens IOLs
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts

Active Comparator: AT Lisa tri (CarlZeiss Meditec AG)
Trifocal, diffractive, +3.33 D near add and +1.66 D intermediate add at the IOL plane, aspheric (aberration correcting) Optic Diameter 6.0 mm Total Diameter 11.0 mm Haptic Angulation 0° Lens Design Single-piece, MICS Incision Size 1.8 mm Company Labeled A-Constant1 118.6 Diopter Range 0.0 to +32.0 D, 0.5 D increments ACD 5.32
Device: multifocal intraocular lens IOLs
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts

Active Comparator: PanOptix(Alcon Laboratories)

Trifocal,Difractive,+3.25D Near,+2.17 D intermediate 6.0mm hydrophobic

-0.27 One piece ,aspheric , Focal 4.5 mm (15 diffractive zones)

Device: multifocal intraocular lens IOLs
clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts

Primary Outcome Measures :
  1. Contrast sensitivity [ Time Frame: 4 years ]
    mean postoperative contrast sensitivity in logarithmic scale under binocular mesopic and photopic conditions. There was no significant difference in the values obtained between at lisa tri and PanOptix at spatial frequencies of 1 cpd and 3, 6, 12, 18 cpd. Eyes with the PanOptix and at lisa tri IOL showed better contrast sensitivity than ReSTOR and Symfony at spatial frequencies of 1, 3, 6 cpd (P<0.001) in photopic and mesopic conditions. The curves achieved with monocular vision were equivalent with binocular vision that was achieved.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Preoperative BCVA (distance) more impacted than 20/40
  • Glare VA test comes about worse than 20/40, or practically impairing dissensions about their vision.
  • By reviewing and judging the researchers, individuals also had a potential need for visual acuity of 20/30 or better after surgery.
  • Express a want for multifocal vision, and be ready and ready to conform to the investigation necessities

Exclusion Criteria:

  • Excluded from entry were subjects with regular astigmatism greater than 1.5 D or irregular astigmatism.
  • Large pupil
  • Corneal transplant surgery or previous glaucoma-filtering,
  • A history of retinal detachments.
  • Also excluded were patients with other clinically non-cataract ocular abnormality (e.g. chronic drug-induced miosis,
  • Endothelial disease
  • Iris neovascularization, and amblyopia)

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Responsible Party: farinaz doroodgar, Clinical Professor, Shahid Beheshti University Identifier: NCT03454334     History of Changes
Other Study ID Numbers: ShahedBU
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases