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

Cataract Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03726606
• Other study ID #: HASH00011
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: May 6, 2019

Study information

• Verified date: October 2018
• Source: Hashmanis Hospital
• Contact: Nauman Hashmani, MBBS
• Phone: 00923212828062
• Email: naumanhashmani[@]hashmanis.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Lenses
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• Intraocular lens
Bilateral implantation of the same intraocular lens.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Hashmanis Hospital	Hashmanis Foundation, SIFI SpA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Near Visual Acuity (Corrected and Uncorrected)	40 cm	3 months after bilateral implantation
Primary	Intermediate Visual Acuity (Corrected and Uncorrected)	66 cm	3 months after bilateral implantation
Primary	Distance Visual Acuity (Corrected and Uncorrected)	4 m	3 months after bilateral implantation
Secondary	Defocus Curve	Evaluating presbyopia correction	3 months after bilateral implantation
Secondary	Objective Automated Refraction	Using a auto refractometer (Topcon KR-800, Tokyo, Japan)	3 months after bilateral implantation
Secondary	Contrast Sensitivity	At 2.5 m	3 months after bilateral implantation
Secondary	Higher Order Abberations	Using a Abberometer	3 months after bilateral implantation
Secondary	Halos and Glares	Using custom software provided by SIFI	3 months after bilateral implantation