Micro insert technology potential option for emmetropic presbyopes

The VisAbility Micro Insert procedure is performed bilaterally, outside the visual axis.

Read sidebar: VisAbility undergoes phase 3 studies

Optometrists have an expanding array of options to offer today’s presbyopes who seek high-quality solutions to their near-vision needs. Unlike previous generations, current presbyopes rely heavily on their near and intermediate vision for digital devices and may be less likely to accept reading glasses. To best meet these needs, optometrists should understand the benefits of available and emerging technologies.

As a sub-investigator in the U.S. clinical trials for the VisAbility Micro Insert System (Refocus Group, Dallas), I provided pre- and postoperative care in our practice for about 70 patients undergoing a new scleral procedure for correcting presbyopia. Under consideration by the FDA, the VisAbility Micro Insert technology is designed for presbyopes between ages 45 and 60 years who have normal ocular health. In our experience, the inserts effectively reduced patients’ dependency on reading glasses.

Jessica Heckman

As patients continue their eye care journey, optometrists can maintain the relationship by remaining on the cutting edge — understanding presbyopia-correcting technologies, educating patients about them, and providing care before and after the procedures they choose.

Bilateral presbyopia correction

Unlike other presbyopia procedures, the VisAbility Micro Insert procedure is performed outside the patient’s visual axis, so it does not affect distance vision. During this procedure, the surgeon implants four micro thin, removable PMMA inserts, smaller than a grain of rice, beneath the scleral surface. It is believed the inserts increase space between the lens and ciliary muscles to increase tension on the zonules and partially restore accommodation.

VisAbility Micro Inserts at 1 month.
Source: Jessica Heckman, OD

The procedure is performed bilaterally, in contrast to other presbyopia procedures such as corneal inlays or LASIK monovision that are performed in one eye. It needs to be done in a surgical center with IV anesthesia and typically takes 20 to 30 minutes. Two dissolvable sutures were used to close the conjunctiva in the clinical trial.

The inclusion criteria for the clinical trial was uncorrected and distance corrected reading vision of 20/50 to 20/80, and the effectiveness endpoint was 20/40 or better and at least 10 letters of ETDRS improvement in distance-corrected near visual acuity.

VisAbility Micro Inserts at 3 months.

Recent reports (Bucci) showed that in a select group of 20 patients participating in the U.S. clinical trial (10 consecutive patients from each of two study sites), 100% achieved J2 or better, and 90% achieved J1 uncorrected near visual acuity, without changes in distance vision or manifest spherical equivalent. Twelve-month results from 360 subjects enrolled in the multicenter U.S. clinical trial are being analyzed.

Understanding patient needs

The primary care optometrist plays an important role in educating patients about presbyopia and potential solutions, which may include high-quality progressive lenses, multifocal contact lenses or surgical options. In my experience, patients are often frustrated when presbyopia begins to affect their near vision and want to know all options for correction, including surgery.

The first step in helping them select an appropriate solution is to ask them about their occupation and lifestyle: How many hours do they spend at a computer? How much time do they spend on visual tasks at work or after hours? What are their hobbies?

If a patient selects a surgical technology, such as VisAbility Micro Inserts, optometrists can continue to play an important role by comanaging their care preoperatively and postoperatively.

Patient selection

VisAbility Micro Inserts are designed for emmetropic presbyopes. Because patients with hyperopia will gain less near vision from the procedure, it is important to identify latent hyperopia.

Patients who cannot tolerate relying on one eye for reading or who do not want to give up distance vision may be particularly interested in this procedure.

In evaluating patients to determine whether they would be good candidates for the VisAbility Micro Inserts, it is essential to perform a preoperative refraction and dilated examination, as we would for any presbyopic procedure.

The quality of the ocular surface plays an important role in the success of any presbyopic surgical procedure, and it needs to be assessed and potentially treated prior to the procedure. Depending on the degree of surface disruption, treatment may include consistent lubrication with artificial tears or management of meibomian gland dysfunction or, in more severe cases, patients may need a topical immunomodulator such as cyclosporine or lifitegrast. If we are proactive in diagnosing and treating ocular surface disease, patients are more likely to heal faster and achieve better outcomes.

Uncorrected near visual acuity (UCNVA) at 40 cm in 20 subjects bilaterally implanted with VisAbility Micro Inserts.
Source: Refocus Group

Patient education before and after the procedure is a critical component of this process. Preoperatively, we need to be sure patients have reasonable expectations regarding visual outcomes, including the need for occasional reading glasses postoperatively for small print and especially dimmer lighting situations. Patients will need to minimize their use of reading glasses after the procedure, allowing the technology to do the work. The more they rely on the inserts, the more quickly they tend to see results and experience better vision.

Postoperative care

After the procedure, patients use a regimen of topical antibiotic and steroid drops. They are seen for follow-up care on a schedule similar to a cataract or refractive surgery patient. An optometrist outside the surgeon’s practice is able to participate in the comanagement of these patients.

During the postoperative examinations, the healing of the inserts is monitored, ensuring they are in proper position and fully covered by conjunctiva. Subconjunctival hemorrhages are typical and temporary, resolving on their own. Postoperative dry eye or inflammation is managed as necessary. The most common condition seen postoperatively at our clinic was dry eye.

Patients notice an improvement in their near vision soon after the procedure, with continued gain over time. Because there is no corneal involvement, there is no risk of corneal haze.

During the healing process, I remind patients to decrease their dependence on reading glasses. To maximize their use of the technology, we may suggest that they perform a visual activity a specific number of times each day. Working with the patient to find a task that interests them, such as finding an app on their phone or solving crossword puzzles, helps with patient compliance.

Optometrists play an important role in the continuum of eye care for patients as they age, helping them choose effective presbyopia correction options. By building a practice that includes surgical comanagement, optometrists can offer patients an expanded array of solutions to their vision needs. Within this collaborative framework, the VisAbility Micro Insert procedure may offer a new opportunity to help your patients reduce their dependency on reading glasses while benefiting your practice.

Mean change in manifest refraction spherical equivalent (MRSE) from baseline in 20 subjects bilaterally implanted with VisAbility Micro Inserts.

Disclosure: Heckman reports no relevant financial interests.

Read sidebar: VisAbility undergoes phase 3 studies

Optometrists have an expanding array of options to offer today’s presbyopes who seek high-quality solutions to their near-vision needs. Unlike previous generations, current presbyopes rely heavily on their near and intermediate vision for digital devices and may be less likely to accept reading glasses. To best meet these needs, optometrists should understand the benefits of available and emerging technologies.

As a sub-investigator in the U.S. clinical trials for the VisAbility Micro Insert System (Refocus Group, Dallas), I provided pre- and postoperative care in our practice for about 70 patients undergoing a new scleral procedure for correcting presbyopia. Under consideration by the FDA, the VisAbility Micro Insert technology is designed for presbyopes between ages 45 and 60 years who have normal ocular health. In our experience, the inserts effectively reduced patients’ dependency on reading glasses.

Jessica Heckman

As patients continue their eye care journey, optometrists can maintain the relationship by remaining on the cutting edge — understanding presbyopia-correcting technologies, educating patients about them, and providing care before and after the procedures they choose.

Bilateral presbyopia correction

Unlike other presbyopia procedures, the VisAbility Micro Insert procedure is performed outside the patient’s visual axis, so it does not affect distance vision. During this procedure, the surgeon implants four micro thin, removable PMMA inserts, smaller than a grain of rice, beneath the scleral surface. It is believed the inserts increase space between the lens and ciliary muscles to increase tension on the zonules and partially restore accommodation.

VisAbility Micro Inserts at 1 month.
Source: Jessica Heckman, OD

The procedure is performed bilaterally, in contrast to other presbyopia procedures such as corneal inlays or LASIK monovision that are performed in one eye. It needs to be done in a surgical center with IV anesthesia and typically takes 20 to 30 minutes. Two dissolvable sutures were used to close the conjunctiva in the clinical trial.

The inclusion criteria for the clinical trial was uncorrected and distance corrected reading vision of 20/50 to 20/80, and the effectiveness endpoint was 20/40 or better and at least 10 letters of ETDRS improvement in distance-corrected near visual acuity.

VisAbility Micro Inserts at 3 months.

Recent reports (Bucci) showed that in a select group of 20 patients participating in the U.S. clinical trial (10 consecutive patients from each of two study sites), 100% achieved J2 or better, and 90% achieved J1 uncorrected near visual acuity, without changes in distance vision or manifest spherical equivalent. Twelve-month results from 360 subjects enrolled in the multicenter U.S. clinical trial are being analyzed.

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Understanding patient needs

The primary care optometrist plays an important role in educating patients about presbyopia and potential solutions, which may include high-quality progressive lenses, multifocal contact lenses or surgical options. In my experience, patients are often frustrated when presbyopia begins to affect their near vision and want to know all options for correction, including surgery.

The first step in helping them select an appropriate solution is to ask them about their occupation and lifestyle: How many hours do they spend at a computer? How much time do they spend on visual tasks at work or after hours? What are their hobbies?

If a patient selects a surgical technology, such as VisAbility Micro Inserts, optometrists can continue to play an important role by comanaging their care preoperatively and postoperatively.

Patient selection

VisAbility Micro Inserts are designed for emmetropic presbyopes. Because patients with hyperopia will gain less near vision from the procedure, it is important to identify latent hyperopia.

Patients who cannot tolerate relying on one eye for reading or who do not want to give up distance vision may be particularly interested in this procedure.

In evaluating patients to determine whether they would be good candidates for the VisAbility Micro Inserts, it is essential to perform a preoperative refraction and dilated examination, as we would for any presbyopic procedure.

The quality of the ocular surface plays an important role in the success of any presbyopic surgical procedure, and it needs to be assessed and potentially treated prior to the procedure. Depending on the degree of surface disruption, treatment may include consistent lubrication with artificial tears or management of meibomian gland dysfunction or, in more severe cases, patients may need a topical immunomodulator such as cyclosporine or lifitegrast. If we are proactive in diagnosing and treating ocular surface disease, patients are more likely to heal faster and achieve better outcomes.

Uncorrected near visual acuity (UCNVA) at 40 cm in 20 subjects bilaterally implanted with VisAbility Micro Inserts.
Source: Refocus Group
PAGE BREAK

Patient education before and after the procedure is a critical component of this process. Preoperatively, we need to be sure patients have reasonable expectations regarding visual outcomes, including the need for occasional reading glasses postoperatively for small print and especially dimmer lighting situations. Patients will need to minimize their use of reading glasses after the procedure, allowing the technology to do the work. The more they rely on the inserts, the more quickly they tend to see results and experience better vision.

Postoperative care

After the procedure, patients use a regimen of topical antibiotic and steroid drops. They are seen for follow-up care on a schedule similar to a cataract or refractive surgery patient. An optometrist outside the surgeon’s practice is able to participate in the comanagement of these patients.

During the postoperative examinations, the healing of the inserts is monitored, ensuring they are in proper position and fully covered by conjunctiva. Subconjunctival hemorrhages are typical and temporary, resolving on their own. Postoperative dry eye or inflammation is managed as necessary. The most common condition seen postoperatively at our clinic was dry eye.

Patients notice an improvement in their near vision soon after the procedure, with continued gain over time. Because there is no corneal involvement, there is no risk of corneal haze.

During the healing process, I remind patients to decrease their dependence on reading glasses. To maximize their use of the technology, we may suggest that they perform a visual activity a specific number of times each day. Working with the patient to find a task that interests them, such as finding an app on their phone or solving crossword puzzles, helps with patient compliance.

Optometrists play an important role in the continuum of eye care for patients as they age, helping them choose effective presbyopia correction options. By building a practice that includes surgical comanagement, optometrists can offer patients an expanded array of solutions to their vision needs. Within this collaborative framework, the VisAbility Micro Insert procedure may offer a new opportunity to help your patients reduce their dependency on reading glasses while benefiting your practice.

Mean change in manifest refraction spherical equivalent (MRSE) from baseline in 20 subjects bilaterally implanted with VisAbility Micro Inserts.

Disclosure: Heckman reports no relevant financial interests.