A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses
Primary Purpose
Cataract, Lenses, Visual Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraocular lens
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Cataract, Intraocular lenses, Trifocal intraocular lenses, Extended depth of focus intraocular lenses, Presbyopia
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Extended depth of focus intraocular lens
Trifocal intraocular lens
Arm Description
Bilateral implantation of extended depth of focus intraocular lenses.
Bilateral implantation of trifocal intraocular lenses.
Outcomes
Primary Outcome Measures
Near Visual Acuity (Corrected and Uncorrected)
40 cm
Intermediate Visual Acuity (Corrected and Uncorrected)
66 cm
Distance Visual Acuity (Corrected and Uncorrected)
4 m
Secondary Outcome Measures
Defocus Curve
Evaluating presbyopia correction
Objective Automated Refraction
Using a auto refractometer (Topcon KR-800, Tokyo, Japan)
Contrast Sensitivity
At 2.5 m
Higher Order Abberations
Using a Abberometer
Halos and Glares
Using custom software provided by SIFI
Full Information
NCT ID
NCT03726606
First Posted
October 29, 2018
Last Updated
October 30, 2018
Sponsor
Hashmanis Hospital
Collaborators
SIFI SpA, Hashmanis Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03726606
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2018 (Anticipated)
Primary Completion Date
May 6, 2019 (Anticipated)
Study Completion Date
May 6, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hashmanis Hospital
Collaborators
SIFI SpA, Hashmanis Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lenses, Visual Impairment
Keywords
Cataract, Intraocular lenses, Trifocal intraocular lenses, Extended depth of focus intraocular lenses, Presbyopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to one of two arms: Trifocal or extended depth of focus intraocular lenses.
Masking
ParticipantOutcomes Assessor
Masking Description
The patient and the examiner will be blinded to the arms.
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Extended depth of focus intraocular lens
Arm Type
Experimental
Arm Description
Bilateral implantation of extended depth of focus intraocular lenses.
Arm Title
Trifocal intraocular lens
Arm Type
Active Comparator
Arm Description
Bilateral implantation of trifocal intraocular lenses.
Intervention Type
Device
Intervention Name(s)
Intraocular lens
Other Intervention Name(s)
Phacoemulsifcation
Intervention Description
Bilateral implantation of the same intraocular lens.
Primary Outcome Measure Information:
Title
Near Visual Acuity (Corrected and Uncorrected)
Description
40 cm
Time Frame
3 months after bilateral implantation
Title
Intermediate Visual Acuity (Corrected and Uncorrected)
Description
66 cm
Time Frame
3 months after bilateral implantation
Title
Distance Visual Acuity (Corrected and Uncorrected)
Description
4 m
Time Frame
3 months after bilateral implantation
Secondary Outcome Measure Information:
Title
Defocus Curve
Description
Evaluating presbyopia correction
Time Frame
3 months after bilateral implantation
Title
Objective Automated Refraction
Description
Using a auto refractometer (Topcon KR-800, Tokyo, Japan)
Time Frame
3 months after bilateral implantation
Title
Contrast Sensitivity
Description
At 2.5 m
Time Frame
3 months after bilateral implantation
Title
Higher Order Abberations
Description
Using a Abberometer
Time Frame
3 months after bilateral implantation
Title
Halos and Glares
Description
Using custom software provided by SIFI
Time Frame
3 months after bilateral implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nauman Hashmani, MBBS
Phone
00923212828062
Email
naumanhashmani@hashmanis.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sharif Hashmani, FCPS
Phone
00923008255771
Email
yashhashmani@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharif Hashmani, FCPS
Organizational Affiliation
Hashmanis Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Comparison of the Visual Performance of Trifocal Versus Extended Depth of Focus Intraocular Lenses
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