A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses

A Randomized, Controlled, Two-armed, and Single Blind Trial Evaluating the Visual Performance and Quality of Vision After Bilateral Implantation of 2 Presbyopia Correcting Intraocular Lenses: Trifocal Versus Extended Depth of Focus

We are conducting a trial evaluating the performance of trifocal versus extended depth of focus intraocular lenses. These lenses will be implanted in otherwise healthy individuals with visual problems due to bilateral cataracts. Patients must be seeking an improvement in their visual performance with a special focus on presbyopia correction.

Study Overview

• Status: Unknown
• Conditions: Cataract; Visual Impairment; Lenses
• Intervention / Treatment: Device: Intraocular lens

Detailed Description

To compare the clinical performance, quality of vision and subjective outcomes between the extended depth of focus (EDOF) Mini Well Ready intraocular lens (IOL) and the diffractive trifocal PanOptix IOL, at 3 months following second eye implantation.

Statistical analysis

All data will be analyzed using the Statistical Package for the Social Sciences (SPSS) v23 (SPSS Inc., Chicago, IL, USA). Graphs will be made using SPSS and Microsoft Excel (Microsoft Corp., Redmond, WA, USA). Normality will be tested for using the Shapiro Wilk test. If the data is normal, an independent t test will be used for comparing the continuous variables between the groups. If the data is not normal, then we will utilize the Mann Whitney U test.

Sample size calculation

The sample size calculation was based on the mean binocular Uncorrected Near Visual Acuity (UNVA) tested at 40cm under photopic condition. A previous study on the same diffractive trifocal IOL revealed a binocular UNVA of 0.01 ± 0.087 logMAR (12). The anticipated mean value for Mini Well Toric Ready is 0.10 logMAR. Based on these assumptions, an alpha of 0.05 and power of 0.8, it was calculated a number of 15 patients implanted bilaterally for each group. Assuming a dropout rate of 20% on the primary outcome measure, this resulted in a total number of 36 bilateral patients, 18 each group.

Duration of the project: Six months to one year

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged 30 years of age or older
• Has bilateral cataracts with visual problems
• Is motivated for vision correction

Exclusion Criteria:

• Any ocular pathology that could impair vision, for example:

  • Pseudoexfoliation syndrome
  • Zonular weakness
  • Retinal or corneal dystrophies
  • Retinal pathologies like age related macular degeneration
• History of trauma
• History of ocular surgery
• Individuals having trouble understanding written or spoken language
• Those with dense cataracts causing problems with optical biometry
• Average corneal powers outside the range of 41 diopters (D) to 46 D
• Corneal astigmatism > 0.75 D
• Irregular astigmatism index of 0.54 or higher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended depth of focus intraocular lens; Bilateral implantation of extended depth of focus intraocular lenses.	Device: Intraocular lens; Bilateral implantation of the same intraocular lens.; Other Names: Phacoemulsifcation
Active Comparator: Trifocal intraocular lens; Bilateral implantation of trifocal intraocular lenses.	Device: Intraocular lens; Bilateral implantation of the same intraocular lens.; Other Names: Phacoemulsifcation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Near Visual Acuity (Corrected and Uncorrected)	40 cm	3 months after bilateral implantation
Intermediate Visual Acuity (Corrected and Uncorrected)	66 cm	3 months after bilateral implantation
Distance Visual Acuity (Corrected and Uncorrected)	4 m	3 months after bilateral implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defocus Curve	Evaluating presbyopia correction	3 months after bilateral implantation
Objective Automated Refraction	Using a auto refractometer (Topcon KR-800, Tokyo, Japan)	3 months after bilateral implantation
Contrast Sensitivity	At 2.5 m	3 months after bilateral implantation
Higher Order Abberations	Using a Abberometer	3 months after bilateral implantation
Halos and Glares	Using custom software provided by SIFI	3 months after bilateral implantation

Collaborators and Investigators

• Sponsor: Hashmanis Hospital
• Collaborators: SIFI SpA; Hashmanis Foundation
• Investigators: Principal Investigator: Sharif Hashmani, FCPS, Hashmanis Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 5, 2018
• Primary Completion (Anticipated): May 6, 2019
• Study Completion (Anticipated): May 6, 2019

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 30, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cataract; Presbyopia; Intraocular lenses; Trifocal intraocular lenses; Extended depth of focus intraocular lenses
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Lens Diseases; Sensation Disorders; Cataract; Vision, Low; Vision Disorders
• Other Study ID Numbers: HASH00011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No