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

To Compare the Clinical Results of Different Multifocal Intraocular Lenses (IOLs) in Patients With Presbyopia or Cataracts

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.

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: multifocal intraocular lens IOLs

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast sensitivity	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.	4 years

Collaborators and Investigators

• Sponsor: Shahid Beheshti University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2013
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): January 14, 2020

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: March 2, 2018
• First Posted (Actual): March 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 10, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: ShahedBU

Drug and device information, study documents

• 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