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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

Clinical study - Intensity

Findings

Preoperative Biometry & VA

ParameterAverage
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

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Efficacy

Visual acuity

Spherical Equivalence

3 Months post-op, n=40

Spherical Equivalence

Monocular Uncorreced Visual Acuity

3 Months post-op, n=40

Uncorrected: Distance - Intermediate - Near

Monocular Correced Visual Acuity

3 Months post-op, n=40

Visual acuity

Binocular Correced Visual Acuity

3 Months post-op, n=40

Both eyes

Contrast sensitivity

3 Months post-op, n=40

Spherical Equivalence

3 Months post, n=40

Refraction accuracy

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

Visual acuity

Satisfaction

What our patients say

Daily activity - Intensity

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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