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2017 Ciliary Muscle Electrostimulation To Restore Accommodation in Patients With Early Presbyopia - Preliminary Results

The document describes a study that tested using pulsed electrostimulation of the ciliary muscle to improve near vision in early presbyopia patients. 27 patients aged 40-51 with early presbyopia received 4 sessions of bilateral pulsed electrostimulation over 2 months, while 13 control patients did not receive treatment. Near vision measures improved significantly in the treatment group but not controls, and most patients reported satisfaction with the results.

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0% found this document useful (0 votes)
70 views8 pages

2017 Ciliary Muscle Electrostimulation To Restore Accommodation in Patients With Early Presbyopia - Preliminary Results

The document describes a study that tested using pulsed electrostimulation of the ciliary muscle to improve near vision in early presbyopia patients. 27 patients aged 40-51 with early presbyopia received 4 sessions of bilateral pulsed electrostimulation over 2 months, while 13 control patients did not receive treatment. Near vision measures improved significantly in the treatment group but not controls, and most patients reported satisfaction with the results.

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Alex Kwan
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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ORIGINAL ARTICLE

Ciliary Muscle Electrostimulation to Restore


Accommodation in Patients With Early
Presbyopia: Preliminary Results
Luca Gualdi, MD; Federica Gualdi, MD; Dario Rusciano, PhD; Renato Ambrósio, Jr., MD, PhD;
Marcella Q. Salomão, MD; Bernardo Lopes, MD; Veronica Cappello, MD; Tatiana Fintina, MD;
Massimo Gualdi, MD

ABSTRACT

PURPOSE: To report short-term results of pulsed ciliary


muscle electrostimulation to improve near vision, likely
P resbyopia, from the Greek words presbys meaning
“old man” and ops meaning to “see like,” is the in-
ability to comfortably focus on close objects due to
aging. This is the most common physiologic alteration of eye-
sight, affecting more than 1.2 billion individuals worldwide,
through restoring accommodation in patients with em-
metropic presbyopia. and leads to a major impact on productivity among healthy
adults.1 Presbyopia also significantly affects quality of life in
METHODS: In a prospective non-randomized trial, 27 both developed and developing countries.2 Unlike ametropic
patients from 40 to 51 years old were treated and defects or refractive errors (myopia, hyperopia, and astigma-
13 age- and refraction-matched individuals served as tism), caused by genetic and envi­ronmental conditions that
untreated controls. All patients had emmetropia and affect the shape of the eye, presbyopia does affect virtually
needed near sphere add between +0.75 and +1.50
diopters. The protocol included four sessions (one every every individual older than 50 or 60 years due to the progres-
2 weeks within a 2-month period) of bilateral pulsed (2 sive loss of the accommodation ability of the eye.
sec on; 6 sec off) micro-electrostimulation with 26 mA Current treatments for presbyopia are based on optical correc-
for 8 minutes, using a commercially available medical tions, but surgical refractive modifications are also possible. Al-
device. The uncorrected distance visual acuity (UDVA) though near vision can be easily recovered by the use of reading
(logMAR) for each eye, uncorrected near (40 cm) visual
acuity in each eye (UNVA) and with both eyes (UNVA OU) glasses, there is nonetheless a great demand for more permanent
(logMAR), and reading speed (number of words read per solutions to avoid the use of corrective lenses. However, available
minute at 40 cm) were measured preoperatively and 2 invasive surgical procedures have several limitations and are not
weeks after each session. Overall satisfaction (0 to 4 devoid of side effects.3 Pharmaceutical treatments stimulating the
scale) was assessed 2 weeks after the last session.
From Diagnostica Oftalmologica e Microchirurgia Oculare, Rome, Italy
RESULTS: UDVA did not change and no adverse events (LG, FG, VC, TF, MG); Sooft Italia SpA, Rome, Italy (DR); Rio de Janeiro
were noted in either group. Bilateral and monocular Corneal Tomography and Biomechanics Study Group, Instituto Olhos Renato
UNVA and reading speed were stable in the control Ambrósio, Rio de Janeiro, Brazil (RA, MQS, BL); and Federal University of São
group, whereas they continuously improved in the Paulo, São Paulo, Brazil (RA, MQS, BL).
treated group (Friedman, P < .00001). Post-hoc sig- Submitted: January 22, 2017; Accepted: May 26, 2017
nificant differences were found for monocular and bin-
ocular UNVA after the second treatment and after the © 2017 Gualdi, Gualdi, Rusciano, et al.; licensee SLACK Incorporated. This is
first treatment considering words read per minute (P < an Open Access article distributed under the terms of the Creative Commons
.001). One patient (3.7%) was not satisfied and 18 pa- Attribution 4.0 International (https://creativecommons.org/licenses/by/4.0).
This license allows users to copy and distribute, to remix, transform, and build
tients (66.7%) were very satisfied (score of 4). Average
upon the article, for any purpose, even commercially, provided the author is
satisfaction score was 3 (satisfied). attributed and is not represented as endorsing the use made of the work.

CONCLUSIONS: Ciliary muscle contraction to restore Dr. Rusciano is a full-time employee of Sooft Italia, the company that com-
mercializes the electrostimulation device in Italy. The remaining authors have
accommodation was safe and improved the short-term
no financial or proprietary interest in the materials presented herein.
accommodative ability of patients with early emme-
tropic presbyopia. The authors thank Dr. Federica Iannella, psychologist (University “La Sapienza,”
Rome, Italy), Dr. Carlo Leoni, psychologist (University “La Sapienza,” Rome,
Italy), and Professor Massimo Biondi, Director of Psychiatric Department
[J Refract Surg. 2017;33(9):578-583.]
(University “La Sapienza,” Rome, Italy), for their contributions elaborating
the results of the Minnesota Test, and Dr. Antony Bridgewood (University of
Catania, Italy) for English proofreading of the manuscript.
Correspondence: Luca Gualdi, MD, Diagnostica Oftalmologica e Microchirurgia
Oculare, Via F. Civinini 111, 00197 Rome, Italy. E-mail: [email protected]
doi:10.3928/1081597X-20170621-05

578
Ciliary Muscle Electrostimulation to Restore Accommodation/Gualdi et al

contraction of ciliary muscles in the presence of differ- The protocol, established after previous experience, in-
ent miotics4-6 and nonsteroidal anti-inflammatory drugs7 cluded four sessions of bilateral pulsed (2 sec on; 6 sec off)
have been recently described, suggesting the relevance of micro-electrostimulation with 26 mA for 8 minutes, with
the stimulation of the ciliary muscle to recover some of its 2-week intervals, using the Ocufit medical device (Sooft;
function. An alternative approach could address the revi- Montegiorgio, Italy) consisting of special lenses and a cali-
talization of the accommodation system by stimulating the brated power supply to which the lenses have to be con-
ciliary muscle to increase its potency so that it can over- nected (see below). Micro-electrostimulation treatments
come the higher resistance of the system (ciliary muscle were performed by the first author (LG) at the Diagnostica
and lens) that has become stiffer due to aging.8 Pulsed elec- Oftalmologica e Microchirurgia Oculare clinic in Rome,
trostimulation is known to work for atrophic muscles9,10 Italy. Two drops of 0.4% oxybuprocaine were instilled
and therefore might also be effective on the ciliary muscle.11 before treatment with the patient in the supine position.
We describe a non-invasive and innovative method to A 20-mm polycarbonate scleral contact lens equipped
improve near vision, likely through restoring the accom- with four microelectrodes at the four cardinal points po-
modation mechanism through pulsed micro-electrostim- sitioned 3.5 mm outside the limbal area corresponding to
ulation of the anterior segment of the eye to stimulate the ciliary body region (Figure A and Video 1, available
ciliary muscle contraction to restore accommodation. in the online version of this article) was used. The micro-
electrodes were connected through four electric pins and
PATIENTS AND METHODS cables to the electrical generator (Figures AA-AC). The
The study was conducted in accordance with the te- lens was carefully applied onto the eye (Figure AD) to
nets of the 1964 Declaration of Helsinki, revised in 2000. avoid trauma to the ocular surface. The electrostimula-
All patients signed an informed consent according to the tor (Sooft) generates biphasic compensated square waves
policies of the Associazione Italiana Medici Oculisti. In for a low voltage micro-electrostimulation of the ciliary
a prospective non-randomized trial, 27 patients from 40 muscle. The amount of electrical current flowing from
to 51 years old were treated and 13 individuals matched the positive to the negative pole remained stable, and
for age and refraction served as untreated controls. All any risk of thermal damage was prevented. During the
patients had emmetropia with an uncorrected distance 8 minutes of treatment, 60 cycles of electrostimulation
visual acuity (UDVA) of 20/20 (0.0 logMAR) or better were given, with each cycle consisting of 2 seconds of
and needed near sphere add between +0.75 and +1.50 electrical impulse and 6 seconds of rest (Figure AE).
diopters (D). Manifest refraction in both groups did not After each treatment, two drops of an antibiotic-steroid
change UDVA with any spherical or cylindrical addi- were instilled in each treated eye to prevent postopera-
tion; all patients had visual acuity of 20/20 or better and tive inflammation or infection. No other medications
a spherical equivalent of ±0.25 D or less (as measured by were needed. Although both eyes could be treated si-
the autorefractometer). Based on these data, cycloplegic multaneously, treatments were generally performed in
refraction was performed only on 5 patients at random one eye with immediate sequential treatment of the fel-
(to avoid the discomfort caused by this procedure to the low eye. The ciliary muscle contraction to restore ac-
rest of the patients), and the resulting spherical equiva- commodation didactic demonstration of the procedure
lent was found to be not more than +0.375 D. is available online (https://youtu.be/724pb1Kyp80).
Exclusion criteria included any ocular pathology, in- Clinical examinations were performed 1 hour prior to the
cluding demyelinating and vascular diseases that may ciliary muscle contraction to restore accommodation treat-
reduce blood perfusion of the ciliary body, and epilepsy. ment and 2 weeks after each treatment (just before starting
Patients who had a pacemaker were also excluded be- the next one). Because the protocol included four sessions,
cause of possible electrical interactions. In addition, pa- the last examination was approximately 2 weeks after the
tients receiving specific treatments that could possibly fourth treatment (or 2 months after enrollment). LogMAR
influence accommodation, such as antidepressant, anti- UDVA for each eye, logMAR uncorrected near (40 cm) vi-
spasmodic, antihistaminic, and diuretic drugs, were also sual acuity in each eye (UNVA) and in both eyes (UNVA
excluded. To exclude patients with obvious psychologi- OU), and reading speed (number of words read per min-
cal problems, all of those enrolled had to complete the ute at 40 cm) were taken preoperatively and 2 weeks after
psychological Minnesota Test questionnaire (MMPI-2), each session. UNVA was measured on standard MNREAD
consisting of 567 questions to which a true or false an- charts at a fixed distance of 40 cm, under standard (500
swer has to be given. The results were elaborated by the lux) illumination and no extra lighting. Reading speed was
Psychology Department of the University “La Sapienza” measured by two orthoptists, one holding a chronometer
in Rome, Italy. Enrolled patients were advised about the and the other counting the words, under standard room il-
possible advantages and limitations of the procedure. lumination on MNREAD charts at 40 cm distance.

Journal of Refractive Surgery • Vol. 33, No. 9, 2017 579


Ciliary Muscle Electrostimulation to Restore Accommodation/Gualdi et al

TABLE 1
LogMAR UNVA (Smallest Character) Data Measured by MNREAD Charts at 40 cm Distance
UNVA Minimum 25th Percentile Median 75th Percentile Maximum
Preop -0.1 0.025 0.12 0.23 0.36
T1 -0.12 0.01 0.1 0.2 0.31
T2 -0.2 0.025 0.1 0.18 0.29
T3 -0.19 0.02 0.09 0.16 0.34
T4 -0.2 0 0.08 0.12 0.24
UNVA = uncorrected near visual acuity; preop = preoperative

Objective variations of the accommodation system Table 1, Tables A-B (available in the online version
were measured (only in one eye randomly chosen from 7 of this article), and Figures 1-3 include the data values
patients) by ultrasound biomicroscopy (Optikon, Rome, and their graphic illustration of UNVA, UNVA OU)
Italy), which was recorded under standard illumination and reading speed defined earlier. UNVA improved
with the patient in the supine position after the instilla- after the second treatment compared to preoperative
tion of two drops of anesthetic (oxybuprocaine) 2 min- values, whereas reading speed was significantly im-
utes before the examination. Three good quality images proved soon after the first treatment. Considering the
were recorded for far vision (with the eye focused on in- UNVA for each eye, there was a continuous improve-
finity, with the lens in the relaxed position) and three for ment. UNVA OU was better than in separated eyes,
near vision (with the eye focused on a near point at 30 which shows the improvement due to binocularity.
cm, with the lens at the maximum accommodation and An ultrasound biomicroscopy study was done on 7
thickness). eyes randomly chosen from 7 treated patients to obtain
Overall satisfaction (0 to 4 scale, where 0 is no a quantitative and objective measurement of the change
satisfaction and 4 is high satisfaction) was assessed occurring during accommodation soon after electro-
2 weeks after the last session, at the time of the last stimulation training. The measurement was taken in the
clinical examination. supine position with both eyes open and one eye had
the ultrasound biomicroscopy immersion measurement
Statistical Analysis taken with the patient looking at distance and to the close
Statistical analyses were performed by different soft- target. The lens curvature and thickness were recorded
ware packages: MedCalc Statistical Software (version at its maximum convexity, showing an average increase
16.8.4; MedCalc, Ostend, Belgium: https://www.medcalc. of +0.07 mm (range: 4.10 to 4.17 mm) of the lens thick-
org) and the R Core Team (version 3.3.1.2016; R Founda- ness, a decrease of the anterior lens curvature of -0.24
tion for Statistical Computing, Vienna, Austria: https:// mm (range: 6.96 to 6.72 mm), and a decrease of the poste-
www.R-project.org). The non-parametric Friedman test rior lens curvature of -0.08 mm (range: 4.60 to 4.52 mm).
was used for testing the differences between the several Figure 4 shows a representative picture of this analysis.
time points for the same patients for each outcome vari- None of the clinical parameters were altered (P >
able analyzed. If the null-hypothesis was rejected with .10) in the control group at the time of their enroll-
a P value of less than .001, pairwise post-hoc analysis ment, and all remained stable over the corresponding
was conducted based on Conover’s method.12 Because time of observation.
the Friedman test is for related samples, all cases had no A subjective questionnaire was given to treated pa-
missing observations for the analyzed variables. tients to record their satisfaction 2 weeks after the end
of the fourth treatment cycle, at the time of the last
RESULTS assessment. Most (96.3%) stated that they were satis-
Among the 27 treated patients, 17 (63%) were wom- fied and felt a real improvement in their visual abil-
en. The average patient age was 45.74 ± 3.35 years ity (highly improved = 10, improved = 8, slightly im-
(range: 40 to 51 years). The control group of 13 indi- proved = 8, not improved = 1).
viduals had 7 women (53.84%) and the average age
was 45.8 ± 3.1 years (range: 40 to 49 years). DISCUSSION
Three of the 27 treated patients (11.11%) reported a dry This is the first clinical report of the results of
eye sensation soon after treatment, which was completely pulsed ciliary muscle contraction to restore accommo-
resolved in 48 hours by using artificial tears containing hy- dation. Although we have reported short-term results
aluronic acid. No other side effects were observed. (up to 2 months), our findings support ciliary muscle

580
Ciliary Muscle Electrostimulation to Restore Accommodation/Gualdi et al

Figure 1. Dot-plot with superimposed box plot of the logMAR uncorrected


near visual acuity (UNVA) (smallest character) measured by MNREAD Figure 2. Dot-plot with superimposed box plot of the logMAR uncorrected
charts at 40 cm distance at the different time points, along with the near visual acuity (smallest character) with both eyes (UNVA OU) measured
pairwise post-hoc significant differences. ***P < .001. by MNREAD charts at 40 cm distance at the different time points, along
with the pairwise post-hoc significant differences. ***P < .001.

contraction to restore accommodation as a promising


treatment for presbyopia.
The complete pathophysiology of presbyopia remains
poorly understood. Donders (1864) proposed that presby-
opia is caused by a decrease in the force of contraction
of the ciliary muscle with age and Helmholtz (1855) sug-
gested that the lens becomes more difficult to deform with
age due to lenticular sclerosis.13 According to the latter
theory, accommodation occurs as a result of the elastic
properties of the lens and possibly the vitreous, which al-
low the lens to expand and increase its power when zonu-
lar tension is relieved during ciliary muscle contraction.14
As the lens changes with age, the ability to expand and in-
crease its refractive power is progressively lost. Possibly,
a combination of these two mechanisms determines the
Figure 3. Dot-plot with superimposed box plot of the reading velocity mea-
evolution and natural course of presbyopia. Interestingly,
sured as the number of words read per minute at the different time points,
Helmholtz’s theory of sclerosis of the crystalline lens as along with the pairwise post-hoc significant differences. ***P < .001.
the cause of presbyopia was challenged by Schachar,15
who suggested that when the longitudinal muscle fibers ods used so far for the correction of presbyopia include
of the ciliary muscle contract during accommodation, contact lenses and spectacles, whereas the surgical cor-
they place more tension on the equatorial zonules while rection of presbyopia remains a challenge for refractive
relaxing the anterior and posterior zonules. This force dis- surgeons.16 Pharmacological attempts to counteract pres-
tribution causes an increase in the equatorial diameter of byopia also exist. They are focused on relieving lens rigid-
the lens, decreasing the peripheral volume while increas- ity (eg, eye drops containing lipoic acid17) or enhancing
ing the central volume. As the central volume increases, iris and ciliary muscle contractility (with a combination
so does the power of the lens. According to Schachar’s of one parasympathetic agent, one NSAID, two alpha-
theory, presbyopia occurs because of the increasing equa- agonists agents, and one anticholinesterase agent).6
torial diameter of the aging lens. Once the lens diameter Accommodation occurs by the contraction (forward
reaches a critical size, usually during the fifth decade of and inward movement) of the ciliary muscle and relax-
life, the ability of the ciliary muscle to provide resting ten- ation of the zonular fibers, resulting in lens thickening
sion on the zonules is significantly reduced. and steepening with consequent increase in the conver-
Although there are several approaches to manage the gence refractive power of the eye.18 Therefore, age-related
visual disability associated with presbyopia, most of the changes in each component of the accommodative ap-
currently available treatments are compensatory optical paratus (either separately or combined) have been impli-
tools rather than corrective, involving more pseudo- cated in the pathophysiology of presbyopia, including
accommodation rather than true accommodation. Meth- lens hardening19 and posterior restriction of the ciliary

Journal of Refractive Surgery • Vol. 33, No. 9, 2017 581


Ciliary Muscle Electrostimulation to Restore Accommodation/Gualdi et al

Figure 4. Example of preoperative (left) and postoperative (right) ultrasound biomicroscopy scan taken under accommodation showing an increased
lens thickness (L) (+0.10 mm), a decreased anterior (Ra) and posterior (Rp) ray of curvature of the lens (-0.16 and -0.08 mm) resulting in improved
accommodative response after the micro-electrostimulation of the ciliary muscle treatment.

muscle.20 Crystalline lens weight progressively increases accommodation partially restores “true physiological
with aging due to the gradual loss of water content and accommodation” differently from other more invasive
the increase of glycoproteins such as albumin and electro- procedures, which create some form of “pseudoaccom-
lytes such as calcium and potassium.21 Moreover, there modation” or other corneal or lenticular aberrations.
is an increment of disulfide bonding, oxidation of me- This may be the subject of further research, likely also
thionine, and deamination and degradation of glutamine based on different evaluation methods.30
and asparagine leading to protein backbone cleavage. The data presented demonstrate that electrostimula-
The consequence is lens stiffening with a progressive de- tion is effective in improving near vision ability in pa-
crease of the refractive power during accommodation.22 tients with early presbyopic emmetropia, which is likely
Therefore, considering the ciliary muscle as the engine of related to restoring the accommodation process because
the accommodative process, and because its magnitude the data suggest that ciliary muscle contraction to re-
of forward centrally and inward movement is reduced store accommodation enhances the ability of the ciliary
with increasing age,23,24 an alternative approach for pres- muscle to contract and thereby perform accommodation.
byopia might be to address its revitalization. Electrostimulation works like training in physiotherapy,
Our hypothesis is that ciliary muscle contraction to so that the best results are expected for young presbyopic
restore accommodation addresses such an active part of patients (40 to 50 years), when the ciliary muscle starts
the accommodation system by working out the ciliary needing more strength to move a stiffer and bigger lens.
muscle to increase its potency, so that it can overcome Also, there should be an age limit for the efficiency of
the higher resistance of the system that has become stiffer such treatment. Interestingly, because presbyopia is con-
due to aging. This approach is already known to work for sidered a preliminary stage prior to age-related cataract,31
atrophic muscles9,10 and might also work on the ciliary in a continuum process described as “dysfunctional lens
muscle. If this hypothesis is correct, then the contraction syndrome,” ciliary muscle contraction to restore accom-
of the ciliary muscle is expected to stretch the tendinous modation could be associated with other treatments that
formation in direct contact with the sclerocorneal trabec- aim to reverse the lens aging process, which leads to
ulate, thus increasing the distance between the lamellae presbyopia and is also associated with ocular hyperten-
of the sclerocorneal angle. In this way, it could also re- sion and possibly cataract formation.
store the natural function of the trabeculate in aged pa- Because ciliary muscle contraction to restore accom-
tients, thus reducing their intraocular pressure.25,26 Ac- modation is a passive exercise, the effect of electrostimu-
cordingly, electrostimulation was found to be effective lation is expected to last for a limited time period and
in decreasing intraocular pressure in patients affected by then progressively regress. To maintain the benefit, it is
ocular hypertension and glaucoma.11,27 necessary to periodically repeat the treatment, which re-
However, based on recent evidence,28,29 the question quires developing customized programs based on the in-
remains as to how ciliary muscle contraction to restore dividual response related to the observed effect. Patient

582
Ciliary Muscle Electrostimulation to Restore Accommodation/Gualdi et al

education is fundamental to ensure realistic expecta- Physiol Opt. 1988;65:407-416.


tions, but also challenging. Further studies are under way 15. Schachar RA. Cause and treatment of presbyopia with a method
for increasing the amplitude of accommodation. Ann Ophthal-
in our clinic (and several others) to optimize the elec- mol. 1992;24:445-447.
trostimulation parameters (time, voltage, and device) to
16. Torricelli AA, Junior JB, Santhiago MR, Bechara SJ. Surgical
improve such results. Moreover, it is possible that novel management of presbyopia. Clin Ophthalmol. 2012;6:1459-1466.
approaches may play a synergistic role in ciliary muscle 17. Garner WH, Garner MH. Protein disulfide levels and lens elastic-
contraction to restore accommodation such as pharmaco- ity modulation: applications for presbyopia. Invest Ophthalmol
logic treatments with lipoic acid17,32 or N-acetylcarnosine Vis Sci. 2016;57:2851-2863.
eye drops33 that appear to work by restoring lens elastic- 18. Glasser A. Accommodation: mechanism and measurement.
Ophthalmol Clin North Am. 2006;19:1-12.
ity and preventing age-related changes.
19. Glasser A, Campbell MC. Biometric, optical and physical chang-
es in the isolated human crystalline lens with age in relation to
AUTHOR CONTRIBUTIONS presbyopia. Vision Res. 1999;39:1991-2015.
Study concept and design (LG, FG, RA, VC, MG); data collection 20. Tamm S, Tamm E, Rohen JW. Age-related changes of the hu-
(LG, DR, TF); analysis and interpretation of data (LG, DR, RA, MQS, man ciliary muscle: a quantitative morphometric study. Mech
BL, TF); writing the manuscript (LG, DR, RA); critical revision of the Ageing Dev. 1992;62:209-221.
manuscript (LG, FG, DR, RA, MQS, BL, VC, TF, MG); statistical ex- 21. Augusteyn RC. Growth of the lens: in vitro observations. Clin
Exp Optom. 2008;91:226-239.
pertise (RA, BL); administrative, technical, or material support (LG,
TF); supervision (LG, FG, VC, MG) 22. Hanson SR HA, Smith DL, Smith JB. The major in vivo modifi-
cations of the human water-insoluble lens crystallins are disul-
fide bonds, deamidation, methionine oxidation and backbone
REFERENCES cleavage. Exp Eye Res. 2000;71:195-207.
1. Frick KD, Joy SM, Wilson DA, Naidoo KS, Holden BA. The 23. Croft MA, Kaufman PL. Accommodation and presbyopia:
global burden of potential productivity loss from uncorrected the ciliary neuromuscular view. Ophthalmol Clin North Am.
presbyopia. Ophthalmology. 2015;122:1706-1710. 2006;19:13-24.
2. Goertz AD, Stewart WC, Burns WR, Stewart JA, Nelson LA. Re- 24. Croft MA, Lütjen-Drecoll E, Kaufman PL. Age-related poste-
view of the impact of presbyopia on quality of life in the develop- rior ciliary muscle restriction: a link between trabecular mesh-
ing and developed world. Acta Ophthalmol. 2014;92:497-500. work and optic nerve head pathophysiology. Exp Eye Res.
3. Papadopoulos PA, Papadopoulos AP. Current management of 2017;158:187-189.
presbyopia. Middle East Afr J Ophthalmol. 2014;21:10-17. 25. Filippello M. Method for prevention of presbyopia and glau-
4. Abdelkader A, Kaufman HE. Clinical outcomes of combined coma, and means for carrying out said treatment. USPTO Patent
versus separate carbachol and brimonidine drops in correcting full text and image database 2015;9,014,812, Apr 21.
presbyopia. Eye Vis (Lond). 2016;3:31. 26. Nesterov AP, Banin VV, Simonova SV. Role of ciliary muscle in
5. Abdelkader A. Improved presbyopic vision with miotics. Eye ocular physiology and disease [article in Russian]. Vestn Oftal-
Contact Lens. 2015;41:323-327. mol.1999;115:13-15.
6. Renna A, Vejarano LF, De la Cruz E, Alió JL. Pharmacologi- 27. Kumar BSh NA. The effect of noninvasive electrostimulation of
cal treatment of presbyopia by novel binocularly instilled eye the optic nerve and retina on visual functions in patients with
drops: a pilot study. Ophthalmol Ther. 2016;5:63-73. primary open angle glaucoma [article in Russian]. Vestn Oftal-
mol. 1994;110:5-7.
7. Benozzi J, Benozzi G, Orman B. Presbyopia: a new potential
pharmacological treatment. Med Hypothesis Discov Innov Oph- 28. Croft MA, McDonald JP, Katz A, Lin TL, Lütjen-Drecoll E,
thalmol. 2012;1:3-5. Kaufman PL. Extralenticular and lenticular aspects of accom-
modation and presbyopia in human versus monkey eyes. Invest
8. Petrash JM. Aging and age-related diseases of the ocular lens and
Ophthalmol Vis Sci. 2013;54:5035-5048.
vitreous body. Invest Ophthalmol Vis Sci. 2013;54:ORSF54-9.
29. Croft MA, Nork TM, McDonald JP, Katz A, Lütjen-Drecoll E,
9. Gould N, Donnermeyer D, Pope M, Ashikaga T. Transcutaneous
Kaufman PL. Accommodative movements of the vitreous
muscle stimulation as a method to retard disuse atrophy. Clin
membrane, choroid and sclera in young and presbyopic hu-
Orthop Relat Res. 1982:215-220.
man and nonhuman primate eyes. Invest Ophthalmol Vis Sci.
10. Kern H, Salmons S, Mayr W, Rossini K, Carraro U. Recovery 2013;54:5049-5058.
of long-term denervated human muscles induced by electrical
30. Richdale K, Sinnott LT, Bullimore MA. Quantification of age-
stimulation. Muscle Nerve. 2005;31:98-101.
related and per diopter accommodative changes of the lens and
11. Nesterov AP, Khadikova EV. Effect of ciliary muscle electrical ciliary muscle in the emmetropic human eye. Invest Ophthal-
stimulation on ocular hydrodynamics and visual function in mol Vis Sci. 2013;54:1095-1105.
patients with glaucoma [article in Russian]. Vestn Oftalmol.
31. McGinty SJ, Truscott RJ. Presbyopia: the first stage of nuclear
1997;113:12-14.
cataract? Ophthalmic Res. 2006;38:137-148.
12. Conover WJ. Practical Nonparametric Statistics. New York:
32. Pescosolido N, Barbato A, Giannotti R, Komaiha C, Lenarduzzi
John Wiley & Sons; 1999.
F. Age-related changes in the kinetics of human lenses: preven-
13. Fisher RF. The mechanics of accommodation in relation to tion of the cataract. Int J Ophthalmol. 2016;9:1506-1517.
presbyopia. Eye (Lond). 1988;2:646-649.
33. Dubois VD, Bastawrous A. N-acetylcarnosine (NAC) drops for age-
14. Stark L. Presbyopia in light of accommodation. Am J Optom related cataract. Cochrane Database Syst Rev. 201728;2:CD009493.

Journal of Refractive Surgery • Vol. 33, No. 9, 2017 583


Figure A. Illustration of the medical device for the electrostimulation of the ciliary muscle. (A) Bottom side of the
lens showing the four electrode contacts. (B) Upper side of the lens showing the four cables to be connected to the
power generator. (C) Positioning of the lenses on the ocular surface of a patient. (D) Power supply during a bilateral
simultaneous treatment in which two scleral contact lenses in polycarbonate are stabilized by two syringes creat-
ing a vacuum and connected by cables directly to the Ocufit (Sooft; Montegiorgio, Italy) electrostimulator medical
device. (E) Pulse trains are in the form of compensated biphasic square-waves. The graph illustrates treatment cycle
sequences consisting in pulsed repetitions of 2 seconds of electrical impulse followed by 6 seconds of rest.
TABLE A
Binocular UNVA (Smallest Character) Data Measured by
MNREAD Charts at 40 cm Distance
Time Minimum 25th Percentile Median 75th Percentile Maximum
Preop -0.2 0.0175 0.1 0.223 0.33
T1 -0.2 0.01 0.1 0.18 0.3
T2 -0.25 0.0025 0.05 0.11 0.23
T3 -0.2 0 0.02 0.1 0.31
T4 -0.2 -0.075 0.02 0.1 0.21
UNVA = uncorrected near visual acuity; preop = preoperative

TABLE B
No. of Words Read per Minute at 40 cm Distance
Time Minimum 25th Percentile Median 75th Percentile Maximum
Preop 76 116 142 161.25 261
T1 103 137.75 162 188.75 262
T2 106 152.75 176 212.75 269
T3 131 165.75 180 228 284
T4 140 178.5 203 217.75 284
preop = preoperative

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