presbyopia: Visual Performance of Four Types of Multifocal Intraocular Lenses

Sponsor
Shahid Beheshti University (Other)
Overall Status
Terminated
CT.gov ID
NCT03454334
Collaborator
(none)
141
4
77.1

Study Details

Study Description

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
  • Device: multifocal intraocular lens IOLs
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
141 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 :
Aug 11, 2013
Actual Primary Completion Date :
Nov 18, 2019
Actual Study Completion Date :
Jan 14, 2020

Arms and Interventions

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 -0.20 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

Outcome Measures

Primary Outcome Measures

  1. Contrast sensitivity [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shahid Beheshti University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
farinaz doroodgar, Ophthalmologist, Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT03454334
Other Study ID Numbers:
  • ShahedBU
First Posted:
Mar 5, 2018
Last Update Posted:
Apr 18, 2022
Last Verified:
Jun 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2022