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An Aspheric Hydrophobic Acrylic Intraocular Lens With Unique Optic Holes.

Abstract: Currently, cataract surgery has evolved into a rapid and increasingly refractive procedure, aiming to achieve optimal visual outcomes without unexpected refractive errors. Patients experience dissatisfaction attributable to several factors, including challenges related to biometry, intraocular lens (IOL) selection and placement, surgical intricacies, capsular bag distension, effective lens position, and rotational instability. The postoperative capsular bag distension is a concern, despite its relatively low incidence. The alteration in effective lens position, leading to refractive surprises, can be attributed to the lifting of the IOL caused by the entrapment of fluids during stromal hydration. Consequently, this can result in posterior capsular bowing or, on occasion, posterior capsule wrinkling. To achieve the above objective, an intraocular lens is a single piece Acrylic Hydrophobic Aspheric lens is prepared having one optical portion and two haptic portions. The invention comprises of unique optic holes that prevents the post-operative complications. According to a preferred embodiment of the invention, the intraocular with four holes is implanted with a routine procedure and lens does not require any special instruments or technique. Therefore, the lens reduces risk of capsule rapture as the practitioner is not required to go behind the intraocular lens to remove the ophthalmic viscosurgical devices (OVD) to reduce risk of Posterior capsule rapture.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
14 June 2023
Publication Number
51/2024
Publication Type
INA
Invention Field
BIO-MEDICAL ENGINEERING
Status
Email
Parent Application

Applicants

BIOTECH VISION CARE PVT. LTD
BLOCK 1, ABHISHREE CORPORATE PARK, OPP. SWAGAT BUNGLOWS, BRTS STOP, BOPAL-AMBLI ROAD, AHMEDABAD-380058, GUJARAT, INDIA.

Inventors

1. DR. ROHIT OM PRAKASH
DR. OM PRAKASH EYE INSTITUTE, 117-A, THE MALL AMRITSAR, PUNJAB-143001 INDIA
2. DR. SHRUTI MAHAJAN
DR. OM PRAKASH EYE INSTITUTE, 117-A, THE MALL AMRITSAR, PUNJAB-143001 INDIA
3. HITENDRA PATEL
BLOCK 1, ABHISHREE CORPORATE PARK,OPP. SWAGAT BUNGALOWS BRTS STOP, BOPAL-AMBLI ROAD AHMEDABAD- 380058,GUJARAT, INDIA
4. PEDAMALLU VVNSP RAJU
BLOCK 1, ABHISHREE CORPORATE PARK,OPP. SWAGAT BUNGALOWS BRTS STOP, BOPAL-AMBLI ROAD AHMEDABAD- 380058,GUJARAT, INDIA.

Specification

FORM 2
THE PATENTS ACT, 1970
(Act 39 of 1970)
COMPLETE SPECIFICATION
(See Section 10)
Title: An Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes
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 THE INVENTION
An Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes. FIELD OF THE INVENTION
The present invention relates to intraocular lens (IOL's). More particularly, the present invention relates to a device with unique optic holes, which prevents post¬operative problems like refractive surprise, capsular bag distension (CBD) and achieves affective lens position and rotational stability.
BACKGROUND OF THE INVENTION
The human eye functions to provide vision by transmitting light through a clear outer portion called the cornea, and focusing the image by way of a crystalline lens onto a retina. The quality of the focused image depends on many factors including the size and shape of the eye, and the transparency of the cornea and the lens.
When age or disease causes the lens to become less transparent (e.g., cloudy), vision deteriorates because of the diminished light, which can be transmitted to the retina. This deficiency in the lens of the eye is medically known as a cataract. Cataract can affect a large percentage of worldwide adult population with clouding of the native crystalline lens and resulting loss of vision. Patients with cataracts can be treated by native lens removal and surgical implantation of synthetic intraocular lens. Factors like biometry issues, intraocular lens issues, surgical factors, capsular bag distension, effective lens position and rotational instability are faced by patients after cataract surgery.
Capsular bags are extremely fragile and may not effectively secure lenses. Capsular bag distension is one of the major concerns for refractive surprise post-operatively. This capsular bag distension changes the position of the refractive lens and cause post-operative refractive surprises. The capsular bag over time wrinkles causing

vision problems and contraction of the capsular bag over the struts of the replacement lens prevents the replacement lens from being removed from the eye in the future.
While early intraocular lens were made from hard plastic, such as polymethylmethacrylate (PMMA), soft, foldable intraocular lens made from acrylate based material have become increasingly popular because of the ability to fold or roll these soft lenses and insert them through a smaller incision. Such acrylate based lenses are particularly desirable because they exhibit excellent folding and unfolding characteristics during and upon implantation within the eye. Such acrylate lenses also exhibit desired biocompatibility characteristics.
One of the proposed mechanisms is lifting of the intraocular lens due to fluid entrapment during stromal hydration. During the stromal hydration, there will be a capsular bag distance between intraocular lens posterior surface and capsular bag.
Another invention US2012309899A1 Disclosed are low-tack, hydrophobic, high refractive index, acrylic materials. These materials, especially useful as intraocular lens materials, contain one or more aryl acrylic hydrophobic monomers as principal device-forming monomers, a tack-reducing macromer additive and a glistening-reducing additive. In addition to their use as intraocular lens materials, the present materials are also suitable for use in other implantable ophthalmic devices.
Yet another invention CN203425064U A hanging type intraocular lens with four fixing holes is implanted into eyes to replace a natural crystalline lens, and is used for fixing a hanging suture for implanting the intraocular lens into a posterior chamber in the case of the posterior capsule loss. The adopted scheme is that two flanges (2) are additionally arranged on the outer side of an intraocular lens optical part (1), the flanges (2) and the optical part (1) are integrally formed, and four fixing holes (3) for allowing the hanging suture to pass through are formed in the flanges (2); when the suture is used for hanging the crystalline lens, the hanging suture penetrates out of the four fixing holes (3) and are fixed on a sclera.

Currently, there are a limited few lenses that have eyelets in their haptics that can be sewn to the eye wall to stabilize them but they often tilt causing visual distortions and once they are sewn in no new lenses can be placed, nor can they be exchanged should the need arise without a major eye Surgery. Thus, there exists significant room for improvement in the art for overcoming these and other shortcomings of conventional systems and methods for securing intraocular lenses.
SUMMARY OF INVENTION
To achieve the above objective, an intraocular lens is a single piece Acrylic Hydrophobic Aspheric lens is prepared having one optical portion and two haptic portions. The invention comprises of unique optic holes that prevents the post operative complications.
According to a preferred embodiment of the invention, the intraocular lens with
four holes is implanted with a routine procedure and lens does not require any special
instruments or technique. Therefore, the lens reduces risk of capsule rapture as the
practitioner is not required to go behind the intraocular lens to remove the ophthalmic
viscosurgi cal devices(OVD) to reduce risk of Posterior capsule rapture.
According to a preferred embodiment of the invention, an aspheric hydrophobic acrylic intraocular lens with unique optic holes prevents capsular bag distension (CBD).
According to a preferred embodiment of the invention, an aspheric hydrophobic acrylic intraocular lens with unique optic holes achieves the rational stability of the intraocular lens.
According to a preferred embodiment of the invention, an aspheric hydrophobic acrylic intraocular lens with unique optic holes controls one of the mechanisms lifting

of the intraocular lens due to fluid entrapment during stromal hydration. During the stromal hydration there will be a capsular bag distance between intraocular lens posterior surface and capsular bag.
According to a preferred embodiment of the invention, an aspheric hydrophobic acrylic intraocular lens with unique optic holes is to control the posterior capsule opacification (PCO).
According to a preferred embodiment of the invention, an aspheric hydrophobic acrylic intraocular lens with unique optic holes is to minimize the photic phenomenon like Dysphotopsia by controlling the posterior capsule wrinkling behind the refractive lens surface.
BRIEF DESCRIPTION OF DRAWINGS
The drawings illustrate example embodiments of the present disclosure. The drawings are not necessarily to scale, may include similar elements that are numbered the same, and may include dimensions (in millimeters) and angles (in degrees) by way of example, not necessarily limitation. In the drawings:
Figure 1 illustrates the front surface (anterior surface) of the intraocular lens.
Figure 2 illustrates the back surface (posterior surface) of the intraocular lens.
Figure 3 illustrates the intraocular lens having four unique fenestrations placed equidistantly in the periphery of the optic portion.
Figure 4 illustrates cross-sectional view of the each fenestration with 500 micron diameter of each fenestration.
Figure 5 illustrates cross-sectional view of reduced diameter of each fenestration to 325 micron.

DETAILED DESCRIPTION OF THE INVENTION
The approach is illustrated by way of example and not by way of limitation in the figures of the accompanying drawings in which like references indicate similar elements. It should be noted that references to "an" or "one" or "some" embodiment(s) in this disclosure are not necessarily to the same embodiment, and such references mean at least one.
The present invention is predicated upon the provision of a single piece acrylic hydrophobic aspheric lens for aiding in the prevention of capsular bag distension, refractive surprise, and posterior capsule wrinkling.
The present invention relates to an artificial intraocular lens comprising an optical medical body (optical part), and a supporting peripheral body means (haptic part) in the shape of at least two loop means which are integral with the optical part and project from the latter. The optical part is provided with two or more peripheral first apertures, and each of said loops at the root thereof is provided with one of said first apertures, and said loops are each provided with a second aperture each at a distance from or at the outer end of the loop.
The invention especially concerns artificial lenses for the human eye which are produced from acrylic (PMMA). It is, however, not intended to limit the invention to production of lenses from this material.
An artificial eye lens (IOL) is used to replace the human eye lens when the latter is removed due to vision impaired by darkening. Such darkening is called cataract. The cause of cataract may be "age", disease, or injury.
The medical term for an artificial lens of the mentioned kind is an artificial intraocular lens. The popular international medical term is IOL. Consequently, the term IOL will be used below.

IOL means produced for PMMA are used in eye surgery since 1949. In recent years a rather explosive development in all industrial countries has been experienced.
IOL means are in principle ranged in two main groups, i.e.:
(1) camera anterior-IOL, and
(2) camera posterior-IOL.
Camera posterior-IOL means comprise two kinds:
(2a) with loops to be fastened in the sulcus proper, and
(2b) with loops to be fastened inside the lens capsule.
The natural anatomic position of an IOL means is inside the lens bag after removal of the lens nuclens and cortex. The lens bag or lens capsule is, ill fact, transparent and does not represent an optical obstruction. By the very fact that the lens bag is not removed the eye retains its natural partition between the anterior and posterior regions of the eye. This will cause less complications than is the case when the cataract is completely removed with the lens bag. The natural barrier between the anterior and posterior regions of the eye would then be broken.
The invention especially concerns IOL means intended to be placed in the lens bag proper, i.e. the above mentioned group 2b. When IOL is mentioned below it should, thus, be understood to be related to the above group 2b.
Today, there is a plurality of different models of IOL means. It is common to them all that they comprise an optical medial body means (optical part), and a supporting peripheral body means (haptic part) in the shape of loops.
In connection with implanting an IOL means the great problem is to have the haptic part inserted into the lens bag. Post examinations in several examination materials show that one of the loops often stays outside the lens bag proper. This is

undesirable for various reasons, probably especially because the optical body will then have an asymmetric position in relation to the optical axis of the eye. Also, a loop or loops remaining outside the lens bag will contact iris tissue and, at worst, cause injury or irritation.
A series of special instruments and techniques are developed to aid the surgeon in placing IOL means in the lens bag. In most IOL means small apertures are provided both in the optical part and in the haptic body. By the aid of instruments the surgeon can engage these apertures to adjust the lens position inside the lens bag.
As disclosed in Figure 1 and Figure 2, comprises of an optic portion wherein the optic portion comprises of an anterior segment (2) to control thickness of lens to fold and unfold easily and a posterior segment having a single radius curvature for entire posterior surface.
Further, as disclosed in figure 3, is a single piece acrylic hydrophobic aspheric lens comprising of four unique fenestrations (4, 5, 6, 7) placed equidistantly in the periphery of the optic portion wherein the lens further comprises of a haptic portion wherein, a modified C type haptics (1,3) providing maximum contact angle with the capsular bags for better rotational stability of the eye.
Figure 4 of the invention discloses that the optic portion of the aspheric hydrophobic lens comprises of four fenestration (4, 5, 6, 7) is having a diameter of 500 microns. Wherein the diameter of the four fenestration (4, 5, 6, 7) was further reduced to 325 microns as disclosed in figure 5.
Further Figure 5 also discloses that the four fenestration (4, 5, 6,7) with reduced micron size controls one of the mechanical lifting of the IOL due to fluid entrapment during stromal hydration, where there will be a capsular bag distance between IOL posterior surface and capsular bag.

The unique arrangement of the four fenestrations (4, 5, 6, 7) equidistant from one another comprising of diameter 325 microns with a refractive index of 1.428 wherein optical size of the IOL is 6mm and the clear optic is 4.74 mm, wherein the IOL of present invention comprises of hydrophobic material.
The IOL lens with four fenestration (4, 5, 6, 7) as disclosed in figures 1-6 attached to the posterior capsule showed that there was a significant prevention of capsular bag distension, maintained the effective lens position and also there was a rotational stability. Therefore, the IOL lens with four unique fenestration of present invention overcomes the problem cited in the prior art effectively.

We Claim,
1. An Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes
comprises of;
a haptic portion wherein, a modified C type haptics (1,3) providing maximum contact angle with the capsular bags for better rotational stability of the eye;
an optic portion wherein the optic portion comprises of an anterior segment (2) to control thickness of lens to fold and unfold easily and a posterior segment having a single radius curvature for entire posterior surface;
the optic portion comprising of a single piece hydrophobic aspheric lens characterized in that, a four fenestrations (4,5,6,7) placed equidistantly in periphery of the optic portion wherein the four fenestrations (4,5,6,7) controls a mechanical lifting of an IOL due to fluid entrapment during stromal hydration.
2. The Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes as
claimed in claim 1, wherein the single piece hydrophobic aspheric lens is selected but
not limited to acrylic material.
3 . The Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes as claimed in claim 1, wherein the four fenestrations (4,5,6,7) having diameter 500 microns diameter further reduced to 325 microns diameter.
4. The Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes as claimed in claim 1, wherein the refractive index is 1.428 with optical size of 6 mm and clear optic is 4.74 mm.
5. The Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes as claimed in claim 1, wherein the four fenestrations (4,5,6,7) equidistant on the hydrophobic aspheric lens preventing capsular bag distension and maintain effective

lens position, controls the posterior capsular opacification (PCO) and rotational stability.
6. The Aspheric Hydrophobic Acrylic Intraocular Lens with Unique Optic Holes as claimed in claim 1, wherein the four fenestrations (4,5,6,7) equidistant on the hydrophobic aspheric lens minimize the photic phenomenon like Dysphotopsia, scattering of the light by controlling the posterior capsule wrinkling behind the refractive lens surface.

Documents

Application Documents

# Name Date
1 202321040475-Other Patent Document-140623.pdf 2023-09-30
2 202321040475-Form 5-140623.pdf 2023-09-30
3 202321040475-Form 3-140623.pdf 2023-09-30
4 202321040475-Form 2(Title Page)-140623.pdf 2023-09-30
5 202321040475-Form 1-140623.pdf 2023-09-30