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

NCT ID: NCT03726606

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-05-06

Brief Summary

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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

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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

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Cataract Lenses Visual Impairment

Keywords

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Cataract Intraocular lenses Trifocal intraocular lenses Extended depth of focus intraocular lenses Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The patient and the examiner will be blinded to the arms.

Study Groups

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Extended depth of focus intraocular lens

Bilateral implantation of extended depth of focus intraocular lenses.

Group Type EXPERIMENTAL

Intraocular lens

Intervention Type DEVICE

Bilateral implantation of the same intraocular lens.

Trifocal intraocular lens

Bilateral implantation of trifocal intraocular lenses.

Group Type ACTIVE_COMPARATOR

Intraocular lens

Intervention Type DEVICE

Bilateral implantation of the same intraocular lens.

Interventions

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Intraocular lens

Bilateral implantation of the same intraocular lens.

Intervention Type DEVICE

Other Intervention Names

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Phacoemulsifcation

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SIFI SpA

INDUSTRY

Sponsor Role collaborator

Hashmanis Foundation

UNKNOWN

Sponsor Role collaborator

Hashmanis Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharif Hashmani, FCPS

Role: PRINCIPAL_INVESTIGATOR

Hashmanis Hospital

Central Contacts

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Nauman Hashmani, MBBS

Role: CONTACT

Phone: 00923212828062

Email: [email protected]

Sharif Hashmani, FCPS

Role: CONTACT

Phone: 00923008255771

Email: [email protected]

Other Identifiers

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HASH00011

Identifier Type: -

Identifier Source: org_study_id