High rates of spectacle independence, patient satisfaction seen with Symfony IOL

A larger range of patients may benefit from implantation of this new presbyopia-correcting lens.

At the American Society of Cataract and Refractive Surgery meeting in May, I reported on the results of four prospective, multicenter clinical investigations of Abbott Medical Optics’ Tecnis Symfony IOL, a new presbyopia-correcting IOL that merges two complementary technologies — an echelette design and achromatic technology — to provide an extended range of continuous vision.

The studies were conducted at 69 sites in the United States, New Zealand and Europe, with 3- to 6-month follow-up of 1,464 eyes of 735 subjects. In each of the studies, patients were randomized to bilateral implantation of either the Symfony lens (ZXR00) or a monofocal control lens (ZCB00). Subjects and evaluators were masked to the IOL implanted.

Study results

Distance visual acuity was comparable in the monofocal and Symfony groups. The Symfony groups had significantly better near and intermediate acuity. There were consistently low reports of visual symptoms: About 90% of subjects across both IOL groups reported no or only mild halos (Figure 1), more than 93% of subjects reported no or only mild glare, and more than 95% reported no or only mild starbursts.

The symptom questionnaires were non-directed — that is, at most sites, subjects were asked if they had experienced any difficulties or problems with their eyes or vision since their last visit. If they had symptoms, they were then asked to specify which symptoms (glare, halo, starbursts) and to rate each symptom as mild, moderate or severe. Twelve European sites asked a more directed question: “Do you experience any glare or halo at any time during the day or night?” Directed questionnaires usually result in higher reports of symptoms, but we found little difference in glare and halo reports between the European study with some directed questionnaires and the other studies.

Most subjects who reported symptoms rated them as mild or moderate. In the U.S. study, for example, reports of severe visual symptoms were less than 2.8% for halos, none for glare and less than 1.5% for starbursts.

Historically, we have seen that 3% to 5% of patients implanted with monofocal aspheric lenses report glare and halo, so there is only a small increase in these studies. It is important to note that the use of femtosecond laser, manual limbal relaxing incisions, and LASIK or PRK enhancement were all disallowed during the study, so residual sphere or cylinder error may also have contributed to the incidence of visual symptoms.

In the European studies, subjects were asked if they would recommend the lens to a friend. Nearly all (97.9% in the Europe-1 study and 93.7% in the Europe-2 study) said yes. A high percentage of patients across studies said they would choose to have the same IOL implanted again (Figure 2). This level of satisfaction is particularly noteworthy given the design of the study. Because patients did not know whether they were getting the monofocal lens or the extended range of vision IOL, they were not counseled about neuroadaptation to the lens or the need to use good light. Surgeons did not attempt to set expectations as we typically would when implanting a presbyopia-correcting IOL.

Personal experience

I personally treated 24 patients in the study, including 11 who received the Symfony lens.

I was pleasantly surprised by how good their near vision was. The mean near acuity was approximately 20/30 in the U.S. trial, and my patients found that they rarely needed reading glasses for normal-sized print in room lighting.

I have not seen the visual symptom data analyzed by refractive error, but my guess is that those with moderate to severe halo or glare are more likely to have been those who needed an enhancement. Certainly that was the case in my practice. Two of my patients who were not fully satisfied initially needed an enhancement after the study was completed.

Role in my practice

We always ask patients about their refractive goals before cataract surgery. For those who want high-quality distance and intermediate vision and do not mind occasionally wearing reading glasses, I will recommend Symfony lenses because I think they will provide a high level of patient satisfaction with less chair time for me.

There will still be some patients who want perfect near vision and may be better candidates for a multifocal IOL, provided the inherent tradeoffs of multifocal IOLs — risk of glare and halo, greater susceptibility to refractive error and less sharp intermediate vision — are acceptable to them.

I may also consider blended vision strategies such as implanting a Symfony lens in the dominant eye and a multifocal ZKB00 or ZLB00 (both Abbott Medical Optics) in the nondominant eye or implanting Symfony in both eyes but leaving the nondominant eye with –0.5 D to –0.75 D of mini-monovision.

I expect that this new category of extended range of vision lenses will invigorate refractive lensectomies in my practice. In the past, I have not been as confident in the ability of multifocal IOLs to satisfy a younger patient who is 20/20 preoperatively, but I expect that will change.

Perhaps most exciting is that I think the Symfony IOL will open up presbyopia-correcting surgery to more patients in my practice. At least 30% (and sometimes up to 50%) of the patients who walk through my door have not been good candidates for presbyopia-correcting IOLs, in my estimation. I have avoiding multifocal IOLs in eyes with any glaucoma or retinal pathology, history of LASIK or retinal surgery, significant dry eye, basement membrane disease or corneal irregularities. Although we can correct regular astigmatism, the need to do a two-step bioptics procedure in astigmatic eyes complicates the decision for both the surgeon and the patient. All of these factors have eliminated from consideration many patients who would otherwise be excited about multifocal IOLs.

Some European papers have already shown good visual outcomes without complaints in patients with concomitant ocular pathology who have Symfony IOLs. Because the distance vision is so comparable to a monofocal and only 8% of light is lost as compared with 10% with traditional diffractive multifocal IOLs, I think I will be more confident in recommending this lens for a 65-year-old with a few drusen or the patient with good vision but a history of epiretinal membrane peel who I might previously have steered toward a monofocal IOL.

There will still be patients who are not good candidates for any presbyopia-correcting IOL, but it is exciting to me that Symfony has the potential to broaden the range of patients who can benefit from presbyopia-correcting technology.

Disclosure: Loden reports he is a paid consultant for Abbott Medical Optics and Omeros.

At the American Society of Cataract and Refractive Surgery meeting in May, I reported on the results of four prospective, multicenter clinical investigations of Abbott Medical Optics’ Tecnis Symfony IOL, a new presbyopia-correcting IOL that merges two complementary technologies — an echelette design and achromatic technology — to provide an extended range of continuous vision.

The studies were conducted at 69 sites in the United States, New Zealand and Europe, with 3- to 6-month follow-up of 1,464 eyes of 735 subjects. In each of the studies, patients were randomized to bilateral implantation of either the Symfony lens (ZXR00) or a monofocal control lens (ZCB00). Subjects and evaluators were masked to the IOL implanted.

Study results

Distance visual acuity was comparable in the monofocal and Symfony groups. The Symfony groups had significantly better near and intermediate acuity. There were consistently low reports of visual symptoms: About 90% of subjects across both IOL groups reported no or only mild halos (Figure 1), more than 93% of subjects reported no or only mild glare, and more than 95% reported no or only mild starbursts.

The symptom questionnaires were non-directed — that is, at most sites, subjects were asked if they had experienced any difficulties or problems with their eyes or vision since their last visit. If they had symptoms, they were then asked to specify which symptoms (glare, halo, starbursts) and to rate each symptom as mild, moderate or severe. Twelve European sites asked a more directed question: “Do you experience any glare or halo at any time during the day or night?” Directed questionnaires usually result in higher reports of symptoms, but we found little difference in glare and halo reports between the European study with some directed questionnaires and the other studies.

Most subjects who reported symptoms rated them as mild or moderate. In the U.S. study, for example, reports of severe visual symptoms were less than 2.8% for halos, none for glare and less than 1.5% for starbursts.

Historically, we have seen that 3% to 5% of patients implanted with monofocal aspheric lenses report glare and halo, so there is only a small increase in these studies. It is important to note that the use of femtosecond laser, manual limbal relaxing incisions, and LASIK or PRK enhancement were all disallowed during the study, so residual sphere or cylinder error may also have contributed to the incidence of visual symptoms.

In the European studies, subjects were asked if they would recommend the lens to a friend. Nearly all (97.9% in the Europe-1 study and 93.7% in the Europe-2 study) said yes. A high percentage of patients across studies said they would choose to have the same IOL implanted again (Figure 2). This level of satisfaction is particularly noteworthy given the design of the study. Because patients did not know whether they were getting the monofocal lens or the extended range of vision IOL, they were not counseled about neuroadaptation to the lens or the need to use good light. Surgeons did not attempt to set expectations as we typically would when implanting a presbyopia-correcting IOL.

Personal experience

I personally treated 24 patients in the study, including 11 who received the Symfony lens.

I was pleasantly surprised by how good their near vision was. The mean near acuity was approximately 20/30 in the U.S. trial, and my patients found that they rarely needed reading glasses for normal-sized print in room lighting.

I have not seen the visual symptom data analyzed by refractive error, but my guess is that those with moderate to severe halo or glare are more likely to have been those who needed an enhancement. Certainly that was the case in my practice. Two of my patients who were not fully satisfied initially needed an enhancement after the study was completed.

PAGE BREAK

Role in my practice

We always ask patients about their refractive goals before cataract surgery. For those who want high-quality distance and intermediate vision and do not mind occasionally wearing reading glasses, I will recommend Symfony lenses because I think they will provide a high level of patient satisfaction with less chair time for me.

There will still be some patients who want perfect near vision and may be better candidates for a multifocal IOL, provided the inherent tradeoffs of multifocal IOLs — risk of glare and halo, greater susceptibility to refractive error and less sharp intermediate vision — are acceptable to them.

I may also consider blended vision strategies such as implanting a Symfony lens in the dominant eye and a multifocal ZKB00 or ZLB00 (both Abbott Medical Optics) in the nondominant eye or implanting Symfony in both eyes but leaving the nondominant eye with –0.5 D to –0.75 D of mini-monovision.

I expect that this new category of extended range of vision lenses will invigorate refractive lensectomies in my practice. In the past, I have not been as confident in the ability of multifocal IOLs to satisfy a younger patient who is 20/20 preoperatively, but I expect that will change.

Perhaps most exciting is that I think the Symfony IOL will open up presbyopia-correcting surgery to more patients in my practice. At least 30% (and sometimes up to 50%) of the patients who walk through my door have not been good candidates for presbyopia-correcting IOLs, in my estimation. I have avoiding multifocal IOLs in eyes with any glaucoma or retinal pathology, history of LASIK or retinal surgery, significant dry eye, basement membrane disease or corneal irregularities. Although we can correct regular astigmatism, the need to do a two-step bioptics procedure in astigmatic eyes complicates the decision for both the surgeon and the patient. All of these factors have eliminated from consideration many patients who would otherwise be excited about multifocal IOLs.

Some European papers have already shown good visual outcomes without complaints in patients with concomitant ocular pathology who have Symfony IOLs. Because the distance vision is so comparable to a monofocal and only 8% of light is lost as compared with 10% with traditional diffractive multifocal IOLs, I think I will be more confident in recommending this lens for a 65-year-old with a few drusen or the patient with good vision but a history of epiretinal membrane peel who I might previously have steered toward a monofocal IOL.

There will still be patients who are not good candidates for any presbyopia-correcting IOL, but it is exciting to me that Symfony has the potential to broaden the range of patients who can benefit from presbyopia-correcting technology.

Disclosure: Loden reports he is a paid consultant for Abbott Medical Optics and Omeros.