Abstract:
A method and apparatus for performing eye surgery. A deformable body having shape memory retentive properties is formed with one or more open loops. The body is longitudinally stretched so that it can follow a needle through a small caliber needle track formed in the cornea, into the anterior chamber in front of the iris. There, the body has relaxed and reverted to its original shape. The needle is of such size that the needle track self-closes and no closure stitch is needed. Two sutures are connected to opposite ends of the body and one of the sutures connects the body to the needle. After the body is in the pupil of the iris, the loop openings face the wall of the iris and then the sutures are pulled to displace the body and press it against the wall of the iris to dilate the pupil.

Description:
FIELD OF THE INVENTION 
       [0001]    The invention relates to methods and apparatus for genera; surgery, especially ocular surgery and in particular for cataract surgery. 
         [0002]    The invention further relates to a device used in such surgery for pupil dilation, for lens capsule dilation and/or for connecting or stabilizing an intraocular lens. 
         [0003]    The invention also relates to apparatus for cinch locking the device during surgery or as a tether to secure the device when it remains in the eye. 
       BACKGROUND AND PRIOR ART 
       [0004]    Methods for retracting tissues to improve visualization or prevent trauma to tissues impinging on a surgical site have been used for centuries. Optical instruments, such as speculums or retraction devices require a surgical opening to be made for their insertion thereby adding to the number of wounds required to accomplish proper exposure. 
         [0005]    Heretofore these devices have been placed through small or large incisions in order to bring retracting or hooking surface to bear against the tissue to be retracted. 
         [0006]    For cataract surgery a large pupil of 6 mm or more is required. When pupils do not dilate well due to the presence of adhesions, inability of the iris musculature to respond to pharmacologic mydriasis, or for other reasons, a mechanical method of enlarging the pupil is necessary. Stretching the iris has been the most common methodology in the last thirty years. 
         [0007]    Speculums were employed in the past for retracting the iris during intracapsular cataract surgery whereby removal of the entire lens utilizing an incision of 8-10 mm or larger was required. The Rosenbaum Drews iris retractor was one such example. The surgeon must hold the retractor with one hand while an assistant lifted the cornea and the surgeon removed the lens with a cryoprobe or other such lens removal device with the dominant hand. Models for left and right handed surgeons were designed. With the onset of modern small incision surgery 1.5-6 mm incisions have been employed. The size limitations of a small incision and the presence of a small pupil required that the iris be cut and moved out of the way, stretched using (Kuglen) hooks, (Beehler) pupil stretchers or that a small (peripheral) or large section of the iris be removed (sector iridectomy) to facilitate cataract removal. Recently the presence of a condition whereby the iris prolapses through the small incision has been described. This condition has been given the name “intraocular floppy iris syndrome” or IFIS. Enlarging the incision or introducing instruments into the eye requires that the pupil remain dilated and the iris be kept away from the incision. Intraocular hooks for retracting the iris or lens capsule developed by Makool are introduced through individual small incisions. Four or five of these incisions and hooks are required to adequately retract the iris. With multiple incisions and multiple hooks to retract the iris, insertion and removal may be problematic. The hooks may rotate into the iris stroma damaging the iris and causing bleeding thereby making surgery more difficult. Insertion and removal of the hooks is technically difficult and many surgeons avoid them for this reason. The introduction of pupillary rings developed by Milverton “Perfect Pupil™”, Malyugin “Malyugin ring” is another method for retracting the iris through the incision which is made for cataract removal. An expanding ring is inserted through the small cataract incision. The expense of the device, and the necessity for learning a new methodology with specially developed insertion and removal tools has limited their use. 
       SUMMARY OF THE INVENTION 
       [0008]    An object of the invention is to provide a speculum or retractor and associated methods for its utilization which avoids the need for hooks or other bulky instruments and their associated incisions as explained above in respect of the prior art. 
         [0009]    A particular object of the invention is to provide a speculum or retractor which can be introduced into the eye without need for an incision or any closure stitch. 
         [0010]    The terms speculum, retractor and speculum retractor are used interchangeably and refer to the same element. 
         [0011]    A further object of the invention is to provide such a speculum or retractor which is made of a deformable material that has shape retentive memory so that it can be installed in a collapsed, deformed state through a needle track into a position adjacent to the iris where it expands to its original state to accomplish various purposes in the eye surgery. 
         [0012]    In accordance with the invention, the speculum is secured to a suture connected to a needle. The needle is inserted through the cornea into the anterior chamber of the eye and exits from a corneal site several millimeters from the entry site. This results in the speculum remaining in the anterior chamber with suture ends external to the eye. The needle diameter is larger than the deformed speculum allowing easy passage of the flexible speculum through the needle track. The speculum can then be manipulated in the anterior chamber through an original cataract incision or a small paracentesis to engage the iris. The suture is pulled up to a desired position of the speculum resulting in dilation of the iris and the pupil being secured. Several of the sutures with speculums are placed to produce the desired degree of dilation of the iris. 
         [0013]    The speculum retractors may also be used to engage the capsular bag, if required, for zonular weakness or absence, or to stabilize a subluxed posterior chamber intraocular lens. The speculum retractors may also be used to support a customized intraocular lens in the absence of capsular or iris support. 
         [0014]    The speculum of the invention has use in general laparoscopic and other forms of surgery of various sizes in which retraction is important for visualization of surgical wounds. 
     
    
     
       DESCRIPTION OF THE FIGURES OF THE DRAWING 
         [0015]      FIG. 1  is a perspective view of one embodiment of a speculum or retractor according to the invention. 
           [0016]      FIG. 2  shows another embodiment of the speculum or retractor according to the invention. 
           [0017]      FIG. 3  diagrammatically illustrates the retractor of  FIG. 1  assembled with a needle and a suture for passing through the cornea. 
           [0018]      FIGS. 3A-3D  diagrammatically illustrate progressively the deformation of the retractor for its entry and passage through the needle track. 
           [0019]      FIG. 4  is a front elevation view which schematically illustrates the placement of the retractor in the anterior chamber of the eye. 
           [0020]      FIG. 5A  diagrammatically illustrates the placement of the speculum into the anterior chamber.  FIG. 5B  shows the placement of the speculum into the peri-pupillary space.  FIG. 5C  shows the final position of the speculum. 
           [0021]      FIG. 6  diagrammatically illustrates a pupil dilated by four retractors. 
           [0022]      FIGS. 7A-7E  diagrammatically illustrate the retractors for tissue retraction. 
           [0023]      FIG. 8  is a rear elevation view that diagrammatically illustrates the retractor as a docking member for an intraocular lens. 
           [0024]      FIG. 9  diagrammatically illustrates a single suture cinch lock for a retractor in operative position dilating an iris. 
           [0025]      FIG. 10A  is a top perspective view of a single cinch lock disc. 
           [0026]      FIG. 10B  is a side view of a single cinch lock disc. 
           [0027]      FIG. 10C  is a side perspective view of a single suture cinch lock disc. 
           [0028]      FIG. 10D  is a top perspective view of a double suture cinch lock disc. 
           [0029]      FIG. 10E  is a side view of a double suture cinch lock disc. 
           [0030]      FIG. 10F  is a side perspective view of a double suture cinch lock disc. 
           [0031]      FIG. 10G  is a diagrammatic view of the suture retractor in the pupil in place and retracting the iris and secured by the cinch lock disc. 
           [0032]      FIG. 11  is similar to  FIG. 10G  but showing double locking and cinching of the suture. 
           [0033]      FIG. 12  is similar to  FIG. 11  and shows a modification in the double locking and cinching of the suture. 
           [0034]      FIGS. 13A-13L  diagrammatically illustrate variations of the suture cinch lock disc. 
           [0035]      FIGS. 14A-14C  diagrammatically illustrate further variations of the suture cinch disc. 
           [0036]      FIGS. 15A-15C  further illustrate suture cinch lock discs. 
           [0037]      FIGS. 16A and 16B  diagrammatically illustrate cinch lock discs. 
           [0038]      FIGS. 17A and 17B  further diagrammatically illustrate the suture cinch lock disc. 
           [0039]      FIGS. 18-20  illustrate an intraocular lens adapted for engagement with the retractor for being secured therewith. 
           [0040]      FIG. 21  diagrammatically illustrates a tether secured to a retractor to hold an intraocular lens. 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    Referring to the drawing and particularly to  FIGS. 1-6 , therein there is seen a portion of an eye of a patient adapted to undergo cataract surgery. In the course of the surgery, an optical instrument in the form of a treatment device will be used and described in greater detail subsequently and which will include and be referred to hereafter, in equivalent terms, as a speculum, retractor or speculum retractor. 
         [0042]    The speculum or retractor is made as a deformable body of shape retentive memory material that is capable of being deformed to a stretched, collapsed position and able to return to its original shape when relaxed and no longer deformed. The body can be a natural biometric material, such as titanium, stainless steel or the like or synthetic materials, such as polypropylene or Nylon provided that it is inert to the human body. 
         [0043]      FIG. 1  diagrammatically illustrates a treatment device comprising a needle  1  of curved shape with a pointed end  2  for piercing body tissue. Connected to the needle, for example, by swaging, or a link coupling, is a flexible suture  3  of conventional suturing material, such as polypropylene or titanium thread. The thread is connected at  4  to one end of the speculum or retractor  5  by swaging or a link connection or the like. At the opposite end  6  of the retractor  5 , it is connected to a further length of suture  7 . 
         [0044]    In order for the speculum to be brought to an operative position in the eye, the needle pierces the cornea  8  (only a portion of which is shown) of the eye and transports the suture  3  and the speculum  5  therewith into the anterior chamber  9  of the eye adjacent to the pupillary aperture or pupil  10  in the iris  11  of the eye. 
         [0045]    In the course of the travel of the needle  1  through the cornea  8 , the needle forms a needle track  12  in the cornea, through which the suture  3  and the deformed, collapsed speculum (to be described in more detail subsequently) pass. The needle  1  is of sufficiently small diameter that the needle track  12  self-closes and a closure stitch is unnecessary. 
         [0046]      FIG. 1  shows the retractor  5  in its initial undeformed state. As shown, the retractor is formed as a continuous length of wire material to constitute a wire-form body and includes two loop members  5 A,  5 B connected by a connecting portion  5 C. The loop members  5 A and  5 B are adapted for engaging the iris or for engaging a lens, or lens capsule as will be explained later. One lower end of loop member  5 A, representing one end  4  of retractor  5 , is connected to suture  3 . An opposite end  6  of retractor  5  is connected to the suture  7 . The loop members are formed as predominantly open semi-circular shape. The loops can have other shapes other than semi-circular as long as it has an opening for insertion of the iris and a curved bearing surface for contacting the iris and applying lifting pressure thereagainst. For example, the loop member can be oval or rectangular with a rounded top or any combination thereof. 
         [0047]      FIG. 2  shows another embodiment of the retractor in which only a single loop member  5 A is provided. As in the previous embodiment, the retractor  5  is connected at its ends to both sutures  3  and  7 . The connection of the suture  3  to the lower end of the loop member is made through a reverse bend at the lower end of the loop member. 
         [0048]    The retractor is deformed as shown in  FIGS. 3A-3C  by applying tension thereto by pulling on the needle  1  in one direction and by pulling on the suture  7  in the opposite direction to stretch and deform the retractor. The needle is pulled through the cornea  9  by a conventional needle holder (not shown) to form the needle track  12 . The suture  3 , the deformed retractor and suture  7  follow in succession. The sequence of the deformation of retractor  5  is shown in  FIGS. 3A-3C . It is seen in particular in  FIG. 3C  that the retractor is substantially in flattened state when fully deformed to enable its passage through the needle track  12 . When the retractor has been introduced into the anterior chamber  9  and the needle has exited from the cornea at an exit site several millimeters from the needle entry site, the needle  1  can be separated from the suture  3  so that both ends of the sutures extend outside the cornea. 
       Dimensions 
       [0049]    A normal corneal diameter is between 11 and 13.5 mm, normal pupil diameter is between 2 and 4mm and the needle length is between 9 and 15 mm. The retractor in its normal undeformed state has a length of 2-3 mm, a height of 0.5-1 mm and a width of 0.5-1 mm. In its deformed flattened state the retractor has a length of 7-8 mm. The retractor has a wire diameter of 0.1-0.2 mm although it need not be circular but can be slightly oval or flattened. The retractor has sufficient strength and rigidity to apply force to the iris to dilate the pupil as will be shown later. 
         [0050]      FIG. 4  is a front view showing the iris  11 , pupil  10  and the retractor  5  installed in the anterior chamber  9 . The sutures  3  and  7  extend outside the cornea. 
         [0051]    As previously explained, after the needle  1  has entered the anterior chamber. the needle exits from the anterior chamber at an exit site several millimeters from the entry site. Thus the retractor has been introduced into the anterior chamber and the sutures  3  and  7  extend out of the cornea. 
         [0052]      FIG. 4  shows a modified embodiment of the retractor  5 ′ on enlarged scale in front of iris  11  with pupil  10 . The retractor has been shown with its loops turned 90 degrees for purposes of illustration. The retractor has loops  5 A′ and  5 B′ connected by connecting portion  5 C′. The retractor can be manipulated to be adjacent to the pupil whereafter the retractor can be displaced into the pupil by means of a hook  13  ( FIG. 5B ) the hook is inserted into the anterior chamber  9  through a paracentesis (not shown) not requiring a closure stitch. The hook  13  is a conventional means used for various displacement purposes in the eye during surgery. 
         [0053]      FIG. 5A  shows the retractor in front of and spaced from the pupil and anterior to lens  14 , in a position in which the openings in the loops  5  A′ and  5 B′ face the edge of the iris with the legs of the loops in a position to straddle the iris so that when the retractor is pulled up, as will be explained later, the loops can engage around the inner peripheral edge of the iris surrounding the pupil.  FIG. 9  more clearly shows the engagement of the loops of the retractor with the iris. In order to retract or stretch the iris and expand the pupil, the ends of the sutures are pulled up to apply pressure by the loops  5 A′ and  5 B′ against the inner surface of the iris as shown in  FIG. 9 .  FIG. 5B  shows a hook  13  engaging the retractor and  FIG. 5C  shows the hook having pushed the retractor into the pupil. 
         [0054]      FIG. 6  diagrammatically shows four substantially equally spaced retractors  5 . The retractors  5  are turned 90 degrees for purposes of illustration. The retractors  5  are engaging iris  11  to dilate the pupil when the retractors are in place in the pupil and their sutures are pulled up. 
         [0055]      FIG. 7  shows a speculum retractor  20  showing loops  21 , the retractor being connected at its ends to sutures  3  and  7 . 
         [0056]      FIGS. 7A-7D  illustrate the use of the retractor for tissue retraction. 
         [0057]    In  FIG. 7A  the needle is shown penetrating and exiting a tissue. The retractor has not yet been used. In  FIG. 7B  the retractor is shown in position with the sutures in place. In  FIG. 7C  the retractors were in position prior to retracting the wound on either side of the vertical incision. In  FIG. 7D  the wound is retracted on either side by the sutures.  FIG. 7E  shows the retractor in place in cross sectional view. 
         [0058]      FIG. 8  shows an intraocular lens (IOL) where haptics  23  are extensions that allow docking with modified speculum retractors which are anchored in the cornea or sclera allowing fixation of the implant without suturing the implant directly. The loops of the retractor are shown turned  90  degrees for purposes of illustration, but it is to be understood when installed the legs of the loops will straddle the leg of the haptic. 
         [0059]      FIG. 9  shows the iris retractor  5  in place in a dilated pupil  10  engaging the peripheral iris  11 . The sutures  6 A and  6 B pass through the cornea at  8 A and  8 B respectively. The suture  6 A is shown with the needle  1 A engaging the indentation of a suture cinch lock disc  15 A 1  at  16  and passing through a slit  17  that extends from the indentation to a hole  15 . The movement of the suture from the indentation  16  to the hole  15  passes across a path Q with the needle moving from  1 A′ to  1 A. The suture  6 B and needle  1 B have not engaged into the hole  15  in this view. 
         [0060]      FIGS. 10A-10G  illustrate a single and double lock suture cinch disc  15 A 1 . 
         [0061]      FIG. 10A  is a top perspective view of a single suture cinch lock disc  15 A 1  having a single indent  16 , a single slit  17  and a single hole  15 . 
         [0062]      FIG. 10B  is a side view of a single suture cinch lock disc  15 A 1  with a single indent  16 , single slit  17  and single hole  15 . 
         [0063]      FIG. 10C  is a side perspective view of a single suture cinch lock disc  15 A 1  with a single indent  16 , single slit  17  and single hole  15 . 
         [0064]      FIG. 10D  is a top perspective view of a double suture cinch lock disc  15 A 2  with two indents  16 ,  18 , two slits  17 ,  19  and two holes  15  and  20 . 
         [0065]      FIG. 10E  is al side view of a double suture cinch lock disc  15 A 2  with two indents  16 ,  18 , two slits  17 ,  19  and two holes  15  and  20 . 
         [0066]      FIG. 10F  is a side perspective view of a double suture cinch lock disc  15 A 2  with two indents  16 ,  18 , two slits  17 ,  19  and two holes  15  and  20 . 
         [0067]      FIG. 10G  is a diagrammatic illustration of the suture retractor  5  in the pupil  7  in place and retracting the iris  7 A. The sutures  6 A and  6 B are connected to the retractor and pass through the cornea at  8 A and  8 B respectively. The needle  1 A is shown already having been placed through the hole  15  of suture cinch lock disc  15 A 2 . The suture  6 B and needle  1 B move into the indent at  16  through arc R into the slit  17  and into the hole  15  across path Q with the suture needle arriving at position  1 B′. 
         [0068]      FIG. 11  is a diagrammatic illustration similar to  FIG. 10G  showing the suture retractor  5  in the pupil  7  in place and retracting the iris  7 A. The sutures  6 A and  6 B are connected to the retractor and pass through the cornea at  8 A and  8 B respectively. The needle  1 A is shown already having been placed through the hole  15  of suture cinch lock disc  15 A 2 . The suture  6 A and needle  1 A move into the indent at  18  through arc  21  and needle at  1 A′, into the slit  19  and into the hole  20  across path  22  with the suture needle arriving at position  1 A″ with the suture  6 A engaged in hole  20  effectively double locking and cinching the suture. The suture  6 B has not been engaged in  15 A in  FIG. 11 . 
         [0069]      FIG. 12  is a diagrammatic view similar to  FIG. 11  with the suture retractor  5  in the pupil  7  in place and retracting the iris  7 A. The sutures  6 A and  6 B are connected to the retractor and pass through the cornea at  8 A and  8 B respectively. The needle  1 A is shown already having been placed through the hole  15  of suture cinch lock disc  15 A 2 . The suture  6 A and needle  1 A are shown in the final position of  FIG. 11 . Suture  6 B and needle  1 B move into the indent at  16  through arc H and needle at  1 B′, into the slit  17  and into the hole  15  across path I with the suture needle arriving at position  1 B″. The suture  6 B is then moved across path J to engage the indent at  18 , the slit at  19  and hole at  20  with needle and suture path K and needle moving from  1 B′″ to  1 B″″ with the suture  6 B engaged in hole  20  effectively double locking and cinching the suture. The sutures  6 A and  6 B are both now double locked. 
         [0070]      FIG. 13A  is a top perspective view of a triple suture cinch lock disc  15 A 3  with three indents  16 ,  18 ,  24 , three slits  23  and three holes  15 ,  21  and  22 . 
         [0071]      FIG. 13B  is a side view of the triple suture cinch lock disc  15 A 3  with three indents  16 ,  18 ,  24 , three slits  23  and three holes  15 ,  21  and  22 . 
         [0072]      FIG. 13C  is a side perspective view of the triple suture cinch lock disc  15 A 3  with three indents  16 ,  18 ,  24 , three slits  23 , and three holes  15 ,  21  and  22 . 
         [0073]      FIG. 13D  is a top view of a quadruple clover leaf shaped suture cinch lock disc  15 A 4  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0074]      FIG. 13E  is a top perspective view of the quadruple clover leaf shaped suture cinch lock disc  15 A 4  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0075]      FIG. 13F  is a side perspective view of the quadruple clover leaf shaped suture cinch lock disc  15 A 4  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0076]      FIG. 13G  is a top view of an S shaped double suture cinch lock disc  15 A 5  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0077]      FIG. 13H  is a top perspective view of the S shaped double suture cinch lock disc  15 A 5  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0078]      FIG. 13I  is a side perspective view of the S shaped double suture cinch lock disc  15 A 5  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0079]      FIG. 13J  is a top view of a double oval shaped double suture cinch lock disc  15 A 6  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0080]      FIG. 13K  is a top perspective view of the double oval shaped double suture cinch lock disc  15 A 6  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0081]      FIG. 13L  is a side view of the double oval shaped double suture cinch lock disc  15 A 6  with four indents  16 , four slits  23 , and four holes  15 ,  20 ,  21  and  22 . 
         [0082]      FIGS. 14A-14C  illustrate a suture cinch lock disc  15 A 7  with an extension hook like loop  30  which may be attached to a suture loop or clamp to fasten the end distal to the surgical site. The extension may be rigid acting as a hook or flexible allowing the extension to stretch exerting significant traction when fixed under tension. 
         [0083]      FIG. 14A  is a top view of a disc  15 A 7  with three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0084]      FIG. 14B  is a side perspective view with three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0085]      FIG. 14C  is a side view with three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0086]      FIGS. 15A-15C  illustrates a suture cinch lock disc  15 A 8  with an extension hook like loop  31  with a central opening  25  which may be attached to a suture loop, peg or clamp to fasten the end distal to the surgical site. The extension may be rigid acting as a hook or flexible allowing the extension to stretch exerting significant traction when fixed under tension. 
         [0087]      FIG. 15A  is a two dimensional top view with three slits  23  and three holes at  15 ,  21  and  22 . 
         [0088]      FIG. 15B  is a side perspective view with three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0089]      FIG. 15C  is a side view with three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0090]      FIGS. 16A -16C  illustrate an adherent means  26  on the back surface of a sure cinch lock disc  15 A 92 . The disc may have a multiplicity of configurations and holes of various sizes to allow for multiple sutures, cords or ropes. 
         [0091]      FIG. 16A  is a top view showing three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0092]      FIG. 16B  is a side perspective view showing three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0093]      FIG. 16C  is a side view showing three slits  23 , and three holes at  15 ,  21  and  22 . 
         [0094]      FIGS. 17A and 17B  diagrammatically illustrates the suture cinch lock disc in position. 
         [0095]      FIG. 17A  diagrammatically illustrates, similar to  FIG. 11 , in which the suture retractor  5  is in the pupil  7  in place and retracting the iris  7 A. The sutures  6 A and  6 B are connected to the retractor and pass through the cornea at  8 A and  8 B respectively. The needles  1 A and  1 B are shown already having been placed through the holes  15 ,  20  of suture cinch lock disc  15 A 2 . 
         [0096]      FIG. 17B  shows three suture cinch lock discs  15 A in position with the retractors  5  retracting the iris  7 A and dilating the pupil  7 . The inset shows the details of the retractor  5  and the suture cinch lock disc  15 A in place. 
         [0097]      FIG. 18  is a front perspective view of the intraocular lens (IOL)  35  similar to  FIG. 8 . The haptics  23  are seen on the back surface of the IOL and are engaged by the loops  5 A and  5 B of the retractors  5 . The sutures  3  and  7  are secured to the sclera (not shown) of the eye. The retractors  5  serve as tethers for the IOL. 
         [0098]      FIG. 19  is a rear view showing the IOL installed in the iris in which the retractors  5 , serving as tethers, engage the haptics  23 , the ends of sutures  3  and  7  are knotted together at knots  36 . The retractors serving as tethers maintain the IOL in place without sulcus or capsule fixation. 
         [0099]      FIG. 20  is a rear perspective view of the IOL showing the engagement of the retractors  8  with the haptics  23 . The sutures  3  and  7  are to be secured to the sclera as previously noted. 
         [0100]      FIG. 21  is an enlarged diagrammatic view of the eye showing the optic nerve  37 , the pars plana region of the retina  38  and the IOL installed in the iris. Also visible are the haptics  23  and the retractors  5 . The sutures  3  and  7  are knotted at  36 .