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

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ClinicalTrials.gov Identifier: NCT03726606
Recruitment Status : Unknown
Verified October 2018 by Hashmanis Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
SIFI SpA
Hashmanis Foundation
Information provided by (Responsible Party):
Hashmanis Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Lenses Visual Impairment Device: Intraocular lens Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: The patient and the examiner will be blinded to the arms.
Primary Purpose: Treatment
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
Estimated Study Start Date : November 5, 2018
Estimated Primary Completion Date : May 6, 2019
Estimated Study Completion Date : May 6, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Extended depth of focus intraocular lens
Bilateral implantation of extended depth of focus intraocular lenses.
 Device: Intraocular lens
Bilateral implantation of the same intraocular lens.
Other Name: Phacoemulsifcation
Active Comparator: Trifocal intraocular lens
Bilateral implantation of trifocal intraocular lenses.
 Device: Intraocular lens
Bilateral implantation of the same intraocular lens.
Other Name: Phacoemulsifcation


Outcome Measures
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Primary Outcome Measures :
  1. Near Visual Acuity (Corrected and Uncorrected) [ Time Frame: 3 months after bilateral implantation ]
    40 cm

  2. Intermediate Visual Acuity (Corrected and Uncorrected) [ Time Frame: 3 months after bilateral implantation ]
    66 cm

  3. Distance Visual Acuity (Corrected and Uncorrected) [ Time Frame: 3 months after bilateral implantation ]
    4 m


Secondary Outcome Measures :
  1. Defocus Curve [ Time Frame: 3 months after bilateral implantation ]
    Evaluating presbyopia correction

  2. Objective Automated Refraction [ Time Frame: 3 months after bilateral implantation ]
    Using a auto refractometer (Topcon KR-800, Tokyo, Japan)

  3. Contrast Sensitivity [ Time Frame: 3 months after bilateral implantation ]
    At 2.5 m

  4. Higher Order Abberations [ Time Frame: 3 months after bilateral implantation ]
    Using a Abberometer

  5. Halos and Glares [ Time Frame: 3 months after bilateral implantation ]
    Using custom software provided by SIFI


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726606


Contacts
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Contact: Nauman Hashmani, MBBS 00923212828062 naumanhashmani@hashmanis.edu.pk
Contact: Sharif Hashmani, FCPS 00923008255771 yashhashmani@hotmail.com

Sponsors and Collaborators
Hashmanis Hospital
SIFI SpA
Hashmanis Foundation
Investigators
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Principal Investigator: Sharif Hashmani, FCPS Hashmanis Hospital
More Information
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Responsible Party: Hashmanis Hospital
ClinicalTrials.gov Identifier: NCT03726606    
Other Study ID Numbers: HASH00011
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hashmanis Hospital:
Cataract
Intraocular lenses
Trifocal intraocular lenses
Extended depth of focus intraocular lenses
Presbyopia
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Cataract
Lens Diseases
 Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases