NCT03726606

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hashmanis Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Cataract
• Lenses
• Visual Impairment

Interventions

Type	Name	Description
DEVICE	Intraocular lens	Bilateral implantation of the same intraocular lens.

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2018-10-31
• Last updated: 2018-10-31