FORM 2
THE PATENTS ACT, 1970
(Act 39 of 1970) COMPLETE SPECIFICATION
Title: Novel Refractive EDOF Intraocular Lens
Name: Biotech Vision Care Pvt. Ltd.
Address: Block 1, Abhishree Corporate park,
Opp. Swagat Bungalows BRTS Stop, Bopal-Ambli Road
Ahmedabad- 380058, Gujarat, India.
Nationality: Indian
The following specification particularly describes the invention and the manner in which it is to be performed.
Title of Invention
Novel Refractive EDOF Intraocular Lens Field of Invention
The present invention relates to intraocular lens. More particularly, the present invention relates to intraocular lens (IOL) with extended focal depth, which helps in providing adequate vision for far objects to intermediate objects with minimized glares and halos.
Background of the invention:
Intraocular lens (IOL) is an artificial lens implanted in the human eye as part of a treatment for cataract surgery. The IOL is implanted during a cataract surgery, after the cloudy eye's natural crystalline lens (colloquially called a cataract) has been removed. The Intraocular lens (IOL) provides the same light focusing function as the natural crystalline lens of the human eye. Most IOLs fitted today are fixed monofocal lenses matched to a particular distance vision. Hence these types of lenses cannot be used to see the objects at various distances simultaneously. Hence the person using this type of lens has to still wear prescription glasses for viewing objects at different distance. For instance, the monofocal lens is generally fitted for viewing distant objects. So, for viewing objects that are closer or at arm's length, glasses are still required. Hence, the glasses need to be carried anywhere even after the monofocal lenses are inserted in the cataract surgery.
Hence, there is a dire need to develop such lenses, which can be used to view the objects at different distances simultaneously, thus giving a continuous vision without the need of wearing glasses.
The prior art document US20030199976A1 relates to a narrow profile, glare reducing, posterior chamber intraocular lens comprises an optic having an anterior surface and a posterior surface and an optical axis. The posterior surface is formed

having two adjacent peri-axial, stepped imaging zones, the two imaging zones having the substantially the same optical power. A transition zone between the two imaging zones preferably has a surface of continuous curvature shaped to reduce direct glare from light incident on the transition zone in an individual's eye in which the intraocular lens is implanted by internal reflection of direct light incident on the transition zone. Attachment members joined to the optic position the intraocular lens in an eye with the optical axis of the optic generally aligned with the optical axis of the eye. In variations, the transition zones are formed at the optic edge to minimize direct and indirect in the eye of an individual wearing the intraocular lens.
However, the above-mentioned prior art document is a thin profile monofocal refractive INTRAOCULAR LENSs for implanting in narrow ocular regions. It thus does not provide a multi focal refractive INTRAOCULAR LENS. Hence it cannot be used to see the objects at different length variation and hence fails to provide a continuous vision without the need of glasses.
The prior art document US6923539B2 relates to monofocal ophthalmic lenses that exhibit extended depth of field while providing sufficient contrast for resolution of an image over a selected range of defocus distances. In some embodiments, a lens of the invention can include a refractive surface having controlled surface modulations relative to a base profile. The surface modulations are designed to extend a depth of field of the lens such that a single image can be resolved, albeit with somewhat less contrast, over a range of distances greater than the focal region of a conventional lens. The ophthalmic lenses of the invention can be employed in various vision correction applications, including, but not limited to, intraocular lenses, contact lenses, intrastromal implants and other refractive devices.
However, the mentioned prior art document can increase the depth of focus for single focus lenses. Hence it cannot be used for multi focal lenses and hence it cannot

be used for viewing objects at multiple distances. Hence these lenses cannot replace multifocal refractive lenses.
Hence all the above-mentioned prior arts fail to provide a multifocal refractive INTRAOCULAR LENS with extended depth of focus, which is essential in order to view the objects from different distances. Also, the above-mentioned prior arts fail the objective to provide continuous vision for objects at different distances without using the glares and halo.
Without limiting the scope of the present invention, a brief summary of some of the claimed embodiments of the present invention is set forth below. Additional details of the summarized embodiments of the present invention and/or additional embodiments of the present invention may be found in the Detailed Description of the Present Invention below.
Summary of the Invention:
The present invention relates to intraocular lens (IOL) with extended focal depth (EDOF), which helps in providing adequate vision for far objects to intermediate objects with minimized glares and halos.
The main objective of the present invention novel refractive EDOF intraocular lens is to provide extended depth of focus to get continuous vision from far distance to intermediate distance around 80 cm distance.
The optimization of each zone and controlled spherical aberration makes the nominal power independent from the pupil size (eye pupil) and minimize haloes and glares in the visual acuity of the patient after implanting the lens in the eye.
Other main objective of the present invention novel refractive EDOF intraocular lens is to provide a pupil independent of the power by using 60-degree segment design in the third zone

Another main objective of the present invention novel refractive EDOF intraocular lens is to minimize glares and halos by providing controlled spherical aberration
Another objective of the present invention Novel refractive EDOF intraocular lens is to balance the nominal power and provide pupil independence
Yet other objective of the present invention Novel refractive EDOF intraocular (IOL) lens is the optimized energy distribution in each annular zone to maintain good contrast irrespective of the pupil size and irrespective of the light conditions
Another objective of the present invention Novel refractive EDOF intraocular lens is to provide balanced light distribution and avoid the poor image quality affects due to decentration or tilt of the INTRAOCULAR LENS by concentric circular zones and 60 deg segments design
Another objective of the present invention Novel refractive EDOF intraocular lens is the outer peripheral circular zone, is given negative curvature to reduce the center thickness of the lens and unfold the lens very gently after passing through a small incision during implantation to the patient.
Another objective of the present invention novel refractive EDOF intraocular lens is in addition of the above mentioned design three small-optimized holes are given at 120-degree distance in the outer peripheral zone irrespective of the haptics position to remove the left viscoelastic material behind the lens surface, which is used during the lens implantation.
Another objective of the present invention novel refractive EDOF intraocular lens is to provide good rotational stability and preventing the early rotation of the INTRAOCULAR LENS after implantation in to the human eye by using modified C type haptics design.

The 360-degree posterior surface square edge of the intraocular lens design will provide proper shrinkage of the capsular bag with the posterior surface of the intraocular lens and prevent the early stage PCO (Posterior Capsular Opacification).
These and other objects of the invention will be appreciated by reference to the drawings of the invention and to the detailed description of the preferred embodiment that follow, it being understood that not all objects are necessarily simultaneously attained by each aspect of the invention, and that not all objects are necessarily fulfilled by each claim of the application.
Brief description of the Drawings:
The illustrated embodiments of the invention will be best understood by reference to the drawings, wherein like parts are designated by like numerals or other labels throughout. The following description is intended only by way of example, and simply illustrates certain selected embodiments of a Novel Refractive EDOF intraocular lens.
Figure 1 represents the anterior surface of the novel extended depth of focus intraocular lens in accordance with the present invention
Figure 2 represents the posterior surface of the novel extended depth of focus intraocular lens in accordance with the present invention
Figure 3 describes the concentric annular zones in the novel extended depth of focus intraocular lens design in accordance with the present invention
Figure 4 describes about the 60-degree arc segments in the toricity zone for novel extended depth of focus intraocular lens design
Figure 5 explains about the power distribution in the respective annular zones in the novel extended depth of focus intraocular lens design

Figure 6 describes about the posterior surface square edge of novel extended depth of focus intraocular lens design
Figure 7describes about the three holes given at peripheral portion of the optic disc of the novel extended depth of focus intraocular lens design
Figure 8 explains about the optical output result (autofocus scan) of the novel extended depth of focus intraocular lens design
Detailed Description of the present invention along with the drawings:
The following paragraphs describe preferred embodiments of the device according to the present invention. The claimed subject matter is described with reference to the drawings, wherein like reference numerals are used to refer to like elements throughout. It will be obvious to a person of ordinary skill in the art will be aware that the activities described are only exemplary and several variations are possible, all of which are understood to fall within the scope of this disclosure. Moreover, the drawings may not be to scale. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present invention. Any benefits, advantages, or solution to problems that are described herein with regard to specific embodiments are not intended to be construed as a critical, required or essential feature or element of any or all the claims.
The terms IOL', 'intraocular lens5, 'lens' are used in same sense in the complete text of this document and may be taken as same for the purpose of disclosing the invention herein.
The terms 'EDOF', 'extended depth of focus', are used in same sense in the complete text of this document and may be taken as same for the purpose of disclosing the invention herein.

The following paragraph describes about the design of novel extended depth of focus Intraocular lens (EDOF INTRAOCULAR LENS) in accordance with the present invention and its outcomes and advantages due to the design. The claimed subject matter is explained with the drawings at required places, where in like reference numerals are used.
The present invention of intraocular lens is called extended depth of focus Intraocular lens (EDOF IOL). These lenses offer clear vision from far distance to intermediate distance up to around 80 cm closer distances. This feature is in addition to providing a far vision.
The Novel Refractive EDOF property is achieved based on the principle of refraction. Refraction is the bending of light ray when passing through one medium to another medium. The bending of light rays are proportional to the curvature of the medium, in which light rays are entering and exist from the medium. Based on this principle the present invention is developed.
The present invention novel refractive extended depth of focus intraocular lens is related to intraocular lenses, which are used in the cataract surgery for replacement of the natural crystalline lens. This novel refractive EDOF lens is developed with hydrophobic acrylic material having the refractive index of 1.52. The design is suitable with the materials like Hydrophilic & Hydrophobic having the range of refractive index higher than aqueous humour like from 1.4 to 1.55 the refractive index. The EDOF intraocular lens design is having single piece structure as described in the figure 1. It shows the front surface of the intraocular lens, which is called as anterior surface of the innovation. The part number 101 represents the center optic portion of the intraocular lens, which is responsible for the light ray refraction inside the eye and part number 102 & part number 103 represents the modified C type haptics of the intraocular lens. The modified C type haptics will provide maximum

contact angle with the capsular bag and will provide the good rotational stability of the INTRAOCULAR LENS to stay stable in the capsular bag of the human eye. The figure 2 represents the back surface of the intraocular lens device, which surface is called as Posterior surface of the intraocular lens. The posterior surface center optic portion represented with the part numbers 104, which is having single radius of curvature on the entire posterior optic surface and part number 105 and 106 represents the haptics of the intraocular lens device.
The center optic portion of the intraocular lens is having the innovative design to provide extended depth of focus to see the objects from far distance to intermediate distance. The center optic portion having four concentric annular refractive zones with in the 4.7 mm clear optic zone on the anterior surface of the optic portion as shown in the figure 3. The part numbers 107 represent the center annular zone with 0.5 D more power to the nominal/base power of the INTRAOCULAR LENS. The part number 108 represents the second annular zone with 0.25 lesser power to the nominal/base power of the INTRAOCULAR LENS. The part number 109 represents the toricity zone. The part number 110 represents the fourth zone in the figure 3 and it is having the optical power of the second zone. As shown in the figure 3-part number 111 represents the outer peripheral circular zone given negative curvature to reduce the center thickness of the lens. It allows the lens to unfold very gently through a small incision during implantation to the patient.
Spherical aberration of the lens plays very important role in the optics. When light rays passing through the lens system, paraxial light rays and marginal light rays focus at different focal points on the optic axis, instead of focusing at a single point. Paraxial light rays focus far away from the lens system and marginal light rays focus nearby lens system in case of positive spherical aberration and in case of negative spherical aberration the light rays focus in the opposite way. The spacing between the two focal points gives the spherical aberration. Based on this principle, the annular zones are given negative and positive spherical aberrations in respective zones. The

first zone was given the 0.3 μm negative spherical aberration with 0.5 diopter more power to the nominal power (this power will be varied as per required depth of focus) to distribute the energy towards lower power side and second zone given the 0.3 μm positive spherical aberration with 0.25 diopter lesser power to the nominal/base power (this power will be varied as per required depth of focus) to distribute the energy towards higher power side. Due to the positive and negative spherical aberration, the energy is distributed between these powers uniformly and provides the extended depth of focus without any glare.
When the pupil/aperture size is small, the light provides the extended depth of focus due to pinhole affect. Hence, when we are giving the higher and lower powers on the first and second optic zones, the energy will be distributed around these focal points and provide good contrast around 3 mm optic zone.
When aperture size will increase, the pinhole affect will decrease and energy will distribute unevenly. Due to this reason the intensity or contrast of the image will decrease. To manage this issue, the third zone is divided into six segments. Each segment having sixty-degree arc length as shown in the figure 4 from the part numbers 112 to 117. The part numbers 112, 114 & 116 segments having the optical power of the first zone and the part numbers 113,115 & 117 segments having the optical power of second zone. These two powers in the alternating segments balance the nominal power and provide the pupil independence at various pupil sizes and provide the extended depth of focus. This toricity zone having the negative spherical aberration of average power of the first two zones. This average power negative spherical aberration will distribute the energy at lower power side and in between nominal and higher power to balance the contrast at different light conditions.
The fourth zone is given the lower power (same power of second zone) with positive spherical aberration to provide sufficient light energy at nominal power in scotopic

light conditions. Each optic zone diameter is optimized by taking optical bench trails to reduce the halos at different pupil sizes and at different light conditions.
The distribution of two powers in four respective zones are represented with solid lines and dotted lines by using hatching methodology in the figure 5 for better understanding.
The figure 6 represents the left side view of the intraocular lens and the part number 118 represents the 360-degree posterior surface square edge of the intraocular lens. The design of the square edge will provide proper shrinkage of the capsular bag with the posterior surface of the intraocular lens and prevent the early stage PCO (Posterior Capsular Opacification).
The above-mentioned design additionally having three small-optimized holes having the diameter of 325 μm (119,120,121) on the peripheral zone at 120-degree apart from each hole irrespective of the haptics position as show in the figure 7. These three holes (119,120,121) can support to remove the left viscoelastic material behind the lens surface, which is used during the lens implantation, and provide proper shrinkage with the capsular bag.
Design specifications of the present invention:
In the design and development of Novel refractive EDOF INTRAOCULAR LENS, Hydrophobic material was used and it was having the refractive index of material 1.524. The design is suitable with the materials like Hydrophilic & Hydrophobic having the range of refractive index higher than aqueous humour like from 1.4 to 1.55 the refractive index. The size of the optic portion is 6 mm and the overall diameter of the INTRAOCULAR LENS is 13.0 mm. These lenses having diopter range from 0.5 D to 40.0 D with a 0.5 D step increment with 1.5 D extended depth of field.
Specifications of the present invention:

Optical Material: Hydrophobic
> Refractive Index: 1.524 (The design is suitable with the materials like Hydrophilic & Hydrophobic having the range of refractive index higher than aqueous humour like from 1.4 to 1.55 the refractive index).
> Optic Surface: Aspheric

> Optical Size of the INTRAOCULAR LENS: 6 mm
> Clear optic: 4.74 mm
> Number of concentric refractive circular zones in the clear optic area: 4 (in the
clear optic zone)
> Number of holes on the peripheral zone: 3
> Diameter of each hole: 325μm
Results of the present invention:
The invention of the Novel, referactive EDOF INTRAOCULAR LENS given satisfactory results on the optical bench performance. Continuous and extended depth of focus(EDOF) as observed in the output result. Figure 8 represents the autofocus scan measurement (Modulation Transfer Function curve) of the intraocular lens measurement.
The Modulation Transfer Function (MTF) curve in the fig 8. shows the achieved EDOF property of the INTRAOCULAR LENS at 3 mm aperture size. The MTF curve representing 0.35 MTF (501ine per mm) at nominal power and it is extended more than 1.5 D depth from the nominal power with more than 0.2 MTF (501ine/mm) value. The

maximum achieved intensity at nominal power is more than 0.3 MTF_50 line/mm, which gives the better contrast of the image at nominal power (distance vision).
Thus, the achieved depth of field is useful to see the objects from far distance to Intermediate distance which covers the arm's length distance also for daily activities like speedometer reading during the driving, computer reading, cooking etc. The present invention provides adequate vision for far objects to intermediate objects with minimized glares and halos. The optimization of each zone and controlled spherical aberration makes the nominal power independent from the pupil size (eye pupil) and minimize haloes and glares in the visual acuity of the patient after implanting the lens in accordance with the present invention in the eye. With many other advantages of the present invention it provides good effective lens position and reduces the Dysphotopsia and control the PCO by using three additional peripheral holes in the design.
The following description is of the best-contemplated mode of carrying out the invention. The description is made for the purpose of illustrating the general principles of the invention and should not be taken in a limiting sense.

Claims:
We Claim:
1. Novel Refractive EDOF INTRAOCULAR LENS which is shaped so as to be assemblable into an assembled state in situ in a capsular bag of human eye so as to have extended depth of focus as well as see the objects from far distance to Intermediate distance which covers the arm's length distance also for daily activities comprising of
Light rays passing through the Novel refractive EDOF INTRAOCULAR LENS made of hydrophobic shape retaining synthetic material with refractive index material of at least 1.5 (The design is suitable with the materials like Hydrophilic & Hydrophobic having the range of refractive index higher than aqueous humour like from 1.4 to 1.55 refractive index).
a posterior and anterior segments with aspheric center optic portion having atleast four concentric annular refractive zones to give negative and positive spherical aberrations in respective zones;
three small-optimized holes having the diameter of 325 μm (119,120,121) on the peripheral zone at 120-degree apart from each hole irrespective of the haptics position;
the outer peripheral circular zone(lll) given negative curvature to reduce the center thickness of the lens
and as the light rays passes, the paraxial light rays and marginal light rays focus at different focal points depending on the positive spherical aberration or negative spherical aberration thus the distribution of two powers in four respective zones is to

provide good effective lens position and reduces the photic phenomena and control the PCO by using three additional peripheral holes in the design.
2. Novel Refractive EDOF INTRAOCULAR LENS of claim 1, wherein the size of the optic portion is 6 mm and the overall diameter of the INTRAOCULAR LENS is 13.0 mm.
3. Novel Refractive EDOF INTRAOCULAR LENS of claim 1, wherein it has a diopter range from 0.5 D to 40.0 D with a 0.5 D step increment with more than 1.5 D extended depth of field.
4. Novel Refractive EDOF INTRAOCULAR LENS of claim 1, wherein the center optic portion having four concentric annular refractive zones within the 4.7 mm clear optic zone on the anterior surface of the optic portion.
5. The concentric annular refractive zones of claim 1, comprises of the center annular zone (107) with 0.5 D more power to the nominal/base power of the INTRAOCULAR LENS to distribute the energy towards lower power side and thus given 0.3 μm negative spherical aberration.

6. The concentric annular refractive zones of claim 1, comprises of the second annular zone(108) given the 0.3 μm positive spherical aberration with 0.25 lesser power to the nominal/base power of the INTRAOCULAR LENS to distribute the energy towards higher power side.
7. The concentric annular refractive zones of claim 1, comprises of the third zone (109) is the torcity zone which is divided into six segments wherein each segment having 60 degree arc length distribute energy evenly specially when the aperture size is bigger.
8. Novel Refractive EDOF INTRAOCULAR LENS of claim 1, wherein if the pupil aperture size is small, the higher and lower powers on the first and second optic zones

will distribute the energy around these focal points and provide good contrast around 3 mm optic zone.
9. The third zone of claim 7, has three segments having the optical power of the first
zone and the other three segments having the optical power of the second zone.
10. The segments of the third zone of claim7, have two optical powers in alternating
segments to balance the nominal power and provide the pupil independence at
various pupil sizes and provide the extended depth of focus.
1.1. The torcicity zone of claim 7, have average power negative spherical aberration which will distribute the energy at lower power side and in between nominal and higher power to balance the contrast at different light conditions.
12. The concentric annular refractive zones of claim 1, comprises of the fourth zone
(110) which is having the optical power of the second zone with positive spherical
aberration to provide sufficient light energy at nominal power in scotopic light
conditions.
Due to the positive and negative spherical aberration, the energy is distributed between these powers uniformly and provides the extended depth of focus without any glare.
13. Novel Refractive EDOF INTRAOCULAR LENS of claim 1, wherein the three holes (119,120,121) can support to remove the left viscoelastic material behind the lens surface which is used during the lens implantation and provide proper shrinkage with the capsular bag.
14. Novel Refractive EDOF INTRAOCULAR LENS of claim 1 provides good rotational stability and preventing the early rotation of the INTRAOCULAR LENS after implantation.

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