Vision Redefined
Initial Clinical Study
Primary goal: To evaluate the monocular & binocular visual acuity for far, intermediate and near distance after the INTENSITY implantation.
Secondary goals: To measure the defocus curve and patient satisfaction.
January 2020
Prof. Ehud I. Assia Hanita Lenses
Our study
The design
This study is a prospective, single arm, single center, open label study.
The aim of this study is to evaluate safety and performance of the INTENSITY IOL.
Participants
Population
Patients diagnosed with cataract who require cataract surgery procedure that meet the inclusion criteria.
Inclusion criteria
Age 45 – 75 years.
Bilateral age-related cataracts, require bilateral cataract.
Axial length of 22-24.5mm.
Corneal astigmatism < 0.75D, regular.
Post-op BCVA expected 0.3 logMAR or better.
Patient motivated for multifocal IOL
No retinal or optic nerve abnormalities
Follow-up
Study status
Findings
Preoperative Biometry & VA
| Parameter | Average |
|---|---|
| SE [D] | - 0.24 |
| UDVA [LogMAR] | 0.56 |
| CDVA [LogMAR] | 0.18 |
| K1 [D] | 43.51 |
| K2 [D] | 43.96 |
| Cyl [D] | 0.45 |
| AL [mm] | 23.34 |
How it works
Efficacy
Visual acuity
Spherical Equivalence
3 Months post-op, n=40
Monocular Uncorreced Visual Acuity
3 Months post-op, n=40
Monocular Correced Visual Acuity
3 Months post-op, n=40
Binocular Correced Visual Acuity
3 Months post-op, n=40
Contrast sensitivity
3 Months post-op, n=40
Spherical Equivalence
3 Months post, n=40
Uncorrected: Distance – Intermediate – Near
1-3 Months post-op Uncorrected, n=26
Visual acuity
1-3 Months post-op Corrected, n=26
Visual acuity
3 Months post-op, n=40
Contrast sensitivity
Performance
Defocus curve
Satisfaction
What our patients say
Glass dependency
Function and satisfaction
Use glasses for near
vision (Reading)?
Never
Use glasses for
Intermediate vision?
Never
Use glasses for
distance vision?
Never
Would you go over the treatment again?
Yes
Are you generally satisfied with the treatment?
Satisfied 2
Very Satisfied 9
Glass dependency
Function and satisfaction
Use glasses for near
vision (Reading)?
Never
Use glasses for
Intermediate vision?
Never
Use glasses for
distance vision?
Never
Would you go over the treatment again?
Yes
Are you generally satisfied with the treatment?
Satisfied 2
Very Satisfied 9
Would you go over the treatment again?
Yes
Are you generally satisfied with the treatment?
Satisfied 2
Very Satisfied 9
Highlights
Conclusions
- A promising new lens design that may truly provide a good range of focus and spectacle freedom to pseudophakic patients.
Results show an excellent defocus curve, with exceptionally good near and intermediate vision without compromising the far vision.
Average visual acuity above 0.05 (6/6.7) throughout infinity to 40 cm.
- High patient satisfaction.
Contact us
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Hanita Lenses
Hanita is a global leader in
innovative solutions for cataract