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

Hashmanis Hospital

Status: Unknown

Conditions: Cataract; Lenses; Visual Impairment

Treatments: Device: Intraocular lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03726606

HASH00011

Details and patient eligibility

About

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.

Full 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

Enrollment: 36 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Extended depth of focus intraocular lens

Experimental group

Description:

Bilateral implantation of extended depth of focus intraocular lenses.

Treatment:

Device: Intraocular lens

Trifocal intraocular lens

Active Comparator group

Description:

Bilateral implantation of trifocal intraocular lenses.

Treatment:

Device: Intraocular lens