A New Opportunity for Shared Care: Scleral Inserts for Presbyopia

A New Opportunity for Shared Care: Scleral Inserts for Presbyopia

Counseling presbyopic patients about their vision correction options is becoming more complex—but also more rewarding. In addition to high-quality progressive spectacles and multifocal contact lenses, there are now several different types of presbyopia-correcting procedures on the market, as well as a new scleral micro-insert option making its way through the FDA approval process.

Patients are having presbyopia surgery earlier. Almost 1 million patients every year now have lens surgery prior to age 651, and many are interested in surgical options as emerging presbyopes. The increasing dependence in our society on digital devices, making near and intermediate vision a high priority, is certainly contributing to the trend, but so is the desire to look and feel younger. Reading glasses are a sign of aging that many younger presbyopes are highly motivated to avoid.

All of this means that now is a good time for optometrists to get up to speed on presbyopia-correcting technologies and how they can benefit our patients and our practices.

New scleral technology

Figure 1

Figure 1. Side view of a Micro-Insert implanted in the sclera.

I’m particularly interested in an innovative new technology for presbyopes in the 45- to 60-year-old age group who don’t yet have lens changes. The VisAbilityTM Micro-Insert System (ReFocus Group, Dallas, Texas) consists of four tiny PMMA inserts, each about the size of a grain of rice (Fig 1, 2), that are implanted in the oblique quadrants of the sclera in each eye, completely outside the visual axis. The micro-inserts create space and increase tension on the zonules. This is exciting because it appears to partially restore accommodation by allowing the zonules to function as nature intended. Other presbyopia-correcting technologies also do a very good job of improving near vision, but in ways (extending the depth of focus, adding power, or multifocality) that are different from how the young eye naturally functions.

Preliminary U.S. study data for the micro-inserts has thus far been quite positive. Reports presented at medical symposia showed that in a select group of 20 patients (10 consecutive patients each from two sites in the clinical trial) 100 percent achieved J2 or better uncorrected near visual acuity (Fig 2), with 90 percent achieving J1 or better at 24 months. There was essentially no change in distance acuity or manifest refractive spherical equivalent from baseline. Twenty-four-month results from all 360 eyes treated in the U.S. clinical trial are now being analyzed.

Three questions about co-management

My expectation is that scleral micro-inserts, once they are approved, will be a great opportunity for co-management between ophthalmologists and optometrists. That’s because I think we can answer “Yes” to all three of the big questions that my colleagues and I have when considering procedures as candidates for shared care:

1. Does it work? - The preliminary study results appear compelling. Of the subset of patients reported out so far, 100 percent achieved uncorrected near visual acuity of J2 or better, and 90 percent were J1, without losing distance vision. We shouldn’t need to worry that we’ll be spending a lot of chair time consoling patients who didn’t get the result they were hoping for.  

2. Is it safe? - This procedure does not involve the visual axis, central cornea, or crystalline lens, and there is no risk of long-term haze, which is very reassuring to my colleagues who may have concerns about other presbyopia procedures.

3. Is the postoperative course relatively straightforward? - It is also compelling that this is a procedure that seems to work without a lot of adjustments, enhancements, or potential complications, all of which can make primary eye care doctors less enthusiastic about managing these patients. It is also completely reversible.

Patient selection

Figure 2

Figure 2. Micro-Insert on a US penny.

As with any presbyopic procedure, it is important to consider the patient’s lifestyle, occupation, other ocular health conditions, and lens status. Scleral micro-insert surgery is likely to be ideal for the presbyope who can enjoy a decade or more of good vision before needing cataract surgery, while patients who already have lens changes may be better candidates for lenticular surgery.

It is important to set the appropriate expectations for the immediate postop period. The advantage of scleral micro-insert is that by avoiding the cornea, the visual axis and the crystalline lens, corneal nerves are unaffected; the disadvantage is that the surgeon is working through vascular tissue. Patients need to know that the procedure will cause some short-term cosmetic effects, similar in degree to what they might experience following a blepharoplasty or retinal surgery.

Postoperative management

Co-managing optometrists will likely see a scleral micro-insert patient back for the Day 1 or Week 1 visit.  Patients would probably be on a tapering regimen of topical antibiotics and anti-inflammatories, similar to a postop cataract regimen.

Figure 3

Figure 3. 100 percent of patients at 2 clinical trial sites achieved bilateral uncorrected near visual acuity of J2 or better with 90 percent achieving J1 or better.

Clinically, it is important to make sure that all the incision points are healing well, demonstrated by a progressive reduction in fluorescein staining. Postoperatively, the optometrist will also be assessing cell and flare in the anterior chamber and ensuring that IOP remains within the normal range.

As noted above, during the first few days, there will be a fair amount of subconjunctival hemorrhage. It is important to reassure the patient that these cosmetic effects are temporary and will resolve. Cool compresses at home can be helpful. Patients do not typically experience much discomfort since the procedure doesn’t affect the corneal nerves.

Because this is a bilateral procedure that doesn’t restrict light or reduce binocularity, patients seem to adapt very quickly to scleral micro-inserts. Although there is some continued improvement over time especially if patients don’t use their reading glasses, there is no need for prolonged neuroadaptation.

Meet your patients where they are

Our patients very much want to find solutions to presbyopia. They are struggling with the loss of near vision and hoping we can guide them towards safe, effective solutions. I believe the explosion in presbyopia correction procedures in general—and scleral micro-inserts in particular—presents an excellent opportunity for optometrists to adjust their practice models to provide more surgical co-management. That starts with educating ourselves about innovative new surgical options and developing good relationships with surgeons whose values are aligned to meet our needs and serve our patients well.

References:

  1. 2015 Comprehensive Report on the Global IOL Market, MarketScope.
Subscribe to eNewsletters
Get the latest ophthalmic industry news and
technology updates related to your interests.

Dr. Karpecki is in private practice at Kentucky Eye Institute. He has no financial interest in the products or company discussed in this paper. Contact him at [email protected].

  • <<
  • >>

Comments