Clinical trial NCT03726606: A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Lenses
Visual Impairment
Keywords: Cataract
Intraocular lenses
Trifocal intraocular lenses
Extended depth of focus intraocular lenses
Presbyopia
Lead sponsor: Hashmanis Hospital
Sponsor class: OTHER
Collaborators: name: SIFI SpA
name: Hashmanis Foundation
First posted: 2018-10-31
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Near Visual Acuity (Corrected and Uncorrected)
timeFrame: 3 months after bilateral implantation
measure: Intermediate Visual Acuity (Corrected and Uncorrected)
timeFrame: 3 months after bilateral implantation
measure: Distance Visual Acuity (Corrected and Uncorrected)
timeFrame: 3 months after bilateral implantation
Secondary outcomes:
measure: Defocus Curve
timeFrame: 3 months after bilateral implantation
measure: Objective Automated Refraction
timeFrame: 3 months after bilateral implantation
measure: Contrast Sensitivity
timeFrame: 3 months after bilateral implantation
measure: Higher Order Abberations
timeFrame: 3 months after bilateral implantation
measure: Halos and Glares
timeFrame: 3 months after bilateral implantation
Other outcomes:
Locations:
Study officials:
affiliation: Hashmanis Hospital
name: Sharif Hashmani, FCPS
role: PRINCIPAL_INVESTIGATOR
References: