In eyes with little or no capsular support, IOL implantation options include anterior chamber open-loop IOLs (AC-IOLs), iris-fixation IOLs (in the anterior or posterior chamber) or scleral-fixation IOLs. There is no general consensus about the best IOL choice in cases that involve insufficient capsular support. When there is no iris support, scleral-fixated IOLs are the only option. Generally, these IOLs are made of a hard PMMA and require large corneal or sclerocorneal incisions, which can induce postsurgical astigmatism. These IOLs are usually fixed with two suture points that cause a risk of optic plate tilting.

To avoid these two complications, we have created a scleral-fixation IOL made of a foldable material. The Ultima IOL (Figure 1) was designed in conjunction with Corneal Industries (Paris) and is a foldable acrylic hydrophilic IOL (26% water content). To the best of our knowledge, it is the first foldable scleral-fixation IOL; it has the unique feature of 360º sulcus support.

The Ultima IOL is circular with a Greek cross design. The total diameter of the lens is 13 mm, and the optic disc diameter is 6.5 mm. The lens is not angulated (Figure 2). The width of the external round loop is 0.45 mm and is connected to the optic disc by four direct arms, each 0.40 mm long. The arms are connected to the external loop with 0.18-mm omega loops.

Omega Loops
The loops allow the lens to adapt to the different diameters of the ciliary sulcus (sulcus diameter differs in the general population and may change with age). Omega loops also absorb shock when the eye is exposed to small trauma or deformations. Four 0.45-mm diameter suture holes in the external loop are positioned at 12:00, 3:00, 6:00 and 9:00. This design provides good IOL stability and centration, even during indentation manoeuvre as in vitreoretinal surgery (the optic disc does not move or tilt, even if the total diameter of the lens is artificially reduced to 11 mm). The Ultima IOL can be inserted through a 4-mm clear-corneal incision.

Achieve a good insertion by surgically performing these 10 points:
1. Conjunctival peritomies and scleral flaps (it is best to perform this part of the surgery with a tonic eye that is not opened).
2. Two paracenteses and a 4-mm self-sealing clear-corneal incision.
3. Upon resolution of insufficient/absent capsular support, perform an anterior vitrectomy through the paracentesis and/or corneal incision.
4. The suture threads (polypropylene 10-0) are passed directly through the ciliary sulcus. The needle handle is inserted through the corneal incision, or the Trimarchi's needle injector (Janach, Como, Italy) is passed through the paracentesis.
5. The suture threads are passed through the IOL holes and then to the fixation points. During this still period, the IOL should be constantly hydrated to maintain its softness.
6. The IOL is then folded using a typical IOL folder (Figure 3) and inserted with the aid of foldable IOL forceps. It is important to first insert the distal part of the external loop to facilitate insertion. Once the lens is inside the eye, the forceps are opened and the suture threads are pulled up. This will help place the IOL in the right position on the ciliary sulcus.
7. The correct positioning of the external loops is achieved with an iris hook.
8. Suture threads are then fixated to the sclera.
9. Hydration or suturing of the corneal incision.
10. The conjunctiva is then sutured or cauterized.

The Ultima lens can also be inserted into the sulcus without sutures, even in the presence of small capsular remnants. In these cases, it is possible to inject the lens with a cartridge through a 3.2-mm incision.

Surgical Results
We have inserted 68 Ultima lenses (61 scleral fixated and 7 without sutures) in a 3-year period. The typical indication for this scleral-fixatation IOL were applied to our patients. These indications include insufficient/absent capsular support, aphakia, dislocated lens in the vitreous, large lens subluxation, traumas, traumatic or nontraumatic IOL luxation, endothelial loss in anterior chamber IOL in association with a perforating keratoplasty, vitreoretinal surgery needing silicone oil in the absence of the lens and when capsular remnants — either during or after cataract surgery — are too small for a typical IOL insertion into the sulcus.

Forty-four males and 17 females (mean age, 45 years) had scleral fixation. Four females and three males (mean age, 61 years) did not have suture points. In the first patient who had posttraumatic aphakia with aniridia, the Ultima lens was sutured with four scleral points at positions 12:00, 3:00, 6:00 and 9:00 (Figure 4). Two suture points were used with the second patient who had traumatic lens luxation in the vitreous. In this patient, surgery was easier, and the IOL remained well centred with no clinical evidence of tilting.

Complications Noted
One complication was cystoid macular edema in the second patient that occurred 2 months after surgery and completely resolved 3 months later with antiflogistic therapy. A second complication was a vitreous hemorrhage and retinal detachment in an eye that had previously undergone three trabeculectomies for refractory glaucoma (the last surgery was with mitomycin C). There was also a chronic closed-angle glaucoma in an eye with a shallow anterior chamber 1 year postsurgery. We inserted the lens into the sulcus without suture, seeing that a large circular posterior capsule remnant was still present after vitreoretinal surgery.

No other intra- or postoperative complications were observed in the other cases. Postsurgical visual improvements were noted in patients who had relatively good retinal conditions prior to surgery. The visual decrease was experienced in the one eye complicated with vitreous hemorrhage, and retinal detachment occurred 6 months later. Complications such as scleral erosion induced by the suture thread or postsurgical point rupture with lens dislocation were not observed.

Surgical Indications
Based on our experience, the Ultima lens appears to be a valid choice for complicated cataract surgery cases. This scleral-fixation lens has two important advantages, being that it is foldable and it is circular. The soft hydrophilic material allows the lens to be inserted and fixed to the scleral using a self-sealing 4-mm clear-cornea incision that normally does not require sutures. Little or no astigmatism is induced. The circular shape of the external loop ensures a 360º ciliary sulcus support, thus providing good IOL stabilization and centration with no optic plate tilting. This broad support system becomes more stable with time, due to fibrosis that occurs at the interface between the loop and the ciliary sulcus.

Moreover, the foldable hydrophilic material offers the additional advantages of less trauma for myotic pupils, less bacterial adhesion, good uveal biocompatibility, prevention of silicone oil passage from the vitreous cavity to the anterior chamber in vitreoretinal surgery and facilitation of lens manipulation during surgery. In fact, in one case a suture thread broke during scleral fixation and the loop was removed out of the corneal incision and adjusted to permit proper fixation. The 6.5-mm diameter of the optic disc permits a good visualization of the ocular fundus.

It Takes Time To Master
Similar to all new developments, time is required to master the technique of properly inserting the Ultima lens. The large lens dimension and the various modes of insertion may initially make for difficult IOL insertion, especially if the surgeon fixes the lens with more than two points. Over time, however, easier insertion of the Ultima IOL is achieved with a good anterior vitrectomy. It is essential to pay close attention to the external loop opening in a sutureless procedure because the lens is large. The iris may prevent a good opening of the loop in cases of bad mydriasis. In this case, it is better to insert the lens with an injector; the loop can unfold on the optic plate and prevent tearing of capsular remnants or eventual vitreal residues.

In conclusion, the Ultima lens may be a step ahead in surgical ophthalmology, as the advantages of a soft IOL inserted in the capsular bag are maintained. The absence of tilting and a small incision permit an optimum optical recovery.

Giuseppe Migliorati, MD, is from the department of ophthalmology, SM Misericordia Hospital in Udine, Italy. He discloses that he has a financial interest in the Ultima lens in the form of a royalty agreement with Corneal Industries. He may be reached at Giuseppe.migliorati@libero.it or +39 3333604055.