Visual outcomes 24 months after LaserACE
Hipsley et al. Eye and Vision
Visual outcomes 24 months after LaserACE
AnnMarie Hipsley 0 1
David Hui-Kang Ma 1 2 3 7
Chi-Chin Sun 1 3 6
Mitchell A. Jackson 0 1 5
Daniel Goldberg 1 4
Brad Hall 1 8
0 Ace Vision Group Inc , 39655 Eureka Drive, Newark, CA 94560 , USA
1 Presented at ASCRS 2015 by Mitchell Jackson , MD April 2015, San Diego, California , USA
2 Department of Chinese Medicine, Chang Gung University , Kweishan, Taoyuan , Taiwan
3 Department of Ophthalmology, Chang Gung Memorial Hospital , Kweishan, Taoyuan , Taiwan
4 Drexel College of Medicine , Philadelphia, PA , USA
5 Jackson Eye , Lake Villa, IL , USA
6 Department of Ophthalmology, Chang Gung Memorial Hospital , Keelung , Taiwan
7 Center for Tissue Engineering, Chang Gung Memorial Hospital , Kweishan, Taoyuan , Taiwan
8 Sengi Data , Cambridge, ON , Canada
Background: To evaluate the effects on near and intermediate visual performance after bilateral Laser Anterior Ciliary Excision (LaserACE) procedure. Methods: LaserACE surgery was performed using the VisioLite 2.94 μm erbium: yttrium-aluminum-garnet (Er:YAG) ophthalmic laser system in 4 oblique quadrants on the sclera over the ciliary muscle in 3 critical zones of physiological importance (over the ciliary muscles and posterior zonules) with the aim to improve natural dynamic accommodative forces. LaserACE was performed on 26 patients (52 eyes). Outcomes were analyzed using visual acuity testing, Randot stereopsis, and the CatQuest 9SF patient survey. Results: Binocular uncorrected near visual acuity (UNVA) improved from +0.20 ± 0.16 logMAR preoperatively, to +0. 12 ± 0.14 logMAR at 24 months postoperatively (p = 0.0014). There was no statistically significant loss in distance corrected near visual acuity (DCNVA). Binocular DCNVA improved from +0.21 ± 0.17 logMAR preoperatively, to +0. 11 ± 0.12 logMAR at 24 months postoperatively (p = 0.00026). Stereoacuity improved from 74.8 ± 30.3 s of arc preoperatively, to 58.8 ± 22.9 s of arc at 24 months postoperatively (p = 0.012). There were no complications such as persistent hypotony, cystoid macular edema, or loss of best-corrected visual acuity (BCVA). Patients surveyed indicated reduced difficulty in areas of near vision, and were overall satisfied with the procedure. Conclusions: Preliminary results of the LaserACE procedure show promising results for restoring visual performance for near and intermediate visual tasks without compromising distance vision and without touching the visual axis. The visual function and visual acuity improvements had clinical significance. Patient satisfaction was high postoperatively and sustained over 24 months.
Presbyopia; Accommodation; Clinical trial; Asian eyes; Visual acuity
Presbyopia has traditionally been defined as the gradual
loss of accommodation resulting from loss of elasticity
of the lens capsule and lens substance only .
Hemholtz’ theory of accommodation described how the
ciliary muscles contract during accommodative effort,
releasing tension on the anterior zonules, and allowing
the elastic lens capsule to reshape and change the
dioptric power of the lens . An inelastic lens would
therefore reduce accommodation, resulting in presbyopia
. Under this model, treatment options could involve
spectacles, contact lenses, and surgical correction.
Surgical correction could be done with either corneal
refractive surgery or intraocular lens replacement .
Corneal refractive procedures include excimer ablation
to create monovision or multifocality, conductive
keratoplasty using radiofrequency waves, and inlays .
Intraocular lens replacement uses monofocal lenses for
monovision, multifocal implants, accommodative
implants, and most recently, extended depth of focus
(EDOF) intraocular implants . Of these modalities,
only intraocular accommodative lenses attempt to
restore accommodation to the presbyopic eye . Also,
corneal presbyopic procedures carry risks of scarring,
night vision problems and vision loss, and lenticular
procedures carry risks of endophthalmitis and night
vision problems .
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Recent research has demonstrated the important role of
the extralenticular structures (including the ciliary body,
zonules, anterior vitreous membrane, and elastic
foundation in the choroid), which have added new direction to the
surgical treatments of presbyopia [7–10]. Using ultrasound
biomicroscopy and endoscopy [7, 8], optical coherence
tomography , and magnetic resonance imaging ,
changes in the vitreous membrane, peripheral choroid,
ciliary muscle, and zonules, as well as the effects of aging,
have been documented. It has also been shown that the
sclera bows inward with increasing age . The loss of
accommodation may be better described by accommodative
lens thickening and resting muscle apex thickness together,
rather than by lens thickening solely . Stiffening of the
zonular apparatus may also contribute to loss of
accommodation . Ocular rigidity has also been correlated with
aging and the loss of accommodation, which have clinical
significance . Finally, the role of proprioceptors in the
vitreous zonular system has been identified and supports
the premise that biomechanical dysfunction impacts the
neuromuscular system of accommodation and the
declining efficiency of accommodative forces . This further
establishes a need for interventions, both surgical and
therapeutic, to restore functional biomechanics in the
The human sclera loses elasticity with age . Ocular
rigidity has been correlated with loss of accommodation and
has been found to have clinical significance for age-related
dysfunction of the eye . In addition, the normal inward
and upward bowing of the sclera upon accommodative
force decreases with age . Laser anterior ciliary excision
(LaserACE) is designed to alter biomechanical properties
and restore compliance to rigid ocular tissue by creating 9
micropores (600 μm in diameter) in a matrix, in the four
oblique quadrants of the eye, and over three critical zones
of anatomical and physiological significance [7, 8, 12, 16–
19]. Hipsley proposed these 3 critical zones of anatomical
and physiological significance to restore accommodative
movements and to promote biomechanical efficiency that
were later validated by in vivo studies [7, 8, 12, 16–19].
These studies have shown that during accommodation, the
sclera moves inward and upward (anteriorly and
centripetally) [7, 8]. Also, the ciliary apex moves forward toward the
lens, which decreases the circumlental space (Zone 1) [7, 8].
This facilitates the force of the ciliary muscle apex at the
scleral spur and longitudinal muscle. Additionally, by
measuring changes in distance between the scleral spur and the
vitreous zonule insertion zone, the vitreous zonule insertion
zone has been shown to move forward during
accommodation [12, 19]. The choroid also moves forward during
accommodation (Zone 2) . Furthermore, the posterior
insertion zone of the vitreous zonules move forward in a
sagittal plane along the curvilinear boundary of the globe
(anteriorly toward the scleral spur) during accommodation
(Zone 3) . This forward movement correlates with
accommodative amplitude, and greater forward movement
leads to higher accommodative amplitude. The forward
movement of the posterior vitreous zonule insertion zone
declines with age, as does the space between the vitreous
membrane and the ciliary body . Thus, in alignment
with recent literature findings regarding locations of
accommodative structures of critical importance, the 3 treatment
zones are as follows and range from 0.5 mm up to 6.0 mm
from the anatomical limbus (AL): 1) the scleral spur at the
origin of the ciliary muscle (0.5 - 1.1 mm from AL); 2) the
mid ciliary muscle body (1.1 – 4.9 mm from AL); and 3)
insertion of the longitudinal muscle fibers of the ciliary, just
anterior to the ora serrata at the insertion of the posterior
vitreous zonules (4.9 – 5.5 mm from AL) [8, 12, 16, 17, 19].
The matrix array of micropores creates regions in the rigid
sclera, which contain areas of both positive stiffness
(remaining interstitial tissue) and negative stiffness
(removed tissue or micropores). This type of arrangement of
the laser-created micropores renders the viscoelastic
modulus of the treated scleral regions more compliant when
subjected to force or stress, such as contraction of the ciliary
muscles . Subsequently, the treated regions of the
micropore mesh are highly capable of plasticity and aim to
produce a dampening effect when the ciliary muscles exert
force. With a more compliant sclera, the distance from the
scleral spur to the posterior insertion zone becomes shorter,
and the accommodative ciliary muscle contraction results in
enhanced anterior and centripetal movement of the ciliary
apex, which allows increased movement of the anterior
zonule and greater lenticular accommodation . In effect, the
reduced scleral rigidity from treatment compensates for the
loss of elasticity in the choroid where the posterior zonules
insert. Therefore, the proposed mechanism of action of
LaserACE is to increase plasticity and compliance of scleral
tissue by creating these regions of micropore mesh over the
ciliary complex, thereby improving biomechanical function
and efficiency of the accommodation apparatus (Fig. 1).
In a previous multicenter international study (Mexico,
Canada, Europe, South America) 134 eyes of 67 patients
received the LaserACE procedure . These studies were
performed serially in each location, iterating the procedure
7 times. The 9-spot matrix was found to be the safest
technique and achieved the desired effect without affecting the
corneal refractive status. This 9-spot pattern is evaluated in
this study. We believe this to be the first long term report
of use of LaserACE to restore near and intermediate visual
performance. Twenty-four-month data obtained from a
clinical trial is reported.
A prospective, non-comparative study was approved at
the Chang Gung Memorial Hospital, Linkou, Taiwan. This
was an Institutional Review Board (IRB) monitored and
Fig. 1 LaserACE surgical procedure. a the three critical zones of significance as measured from the anatomical limbus; b restored mechanical
efficiency and improved biomechanical mobility (procedure objectives)
registered international clinical pilot study approved by
IRB.GOV, and followed the tenets of the Declaration of
Helsinki and local Taiwan healthcare laws. After a full
explanation of the purpose of the study and the LaserACE
procedure, signed informed consent was obtained from all
patients. All study participants agreed to return for the
postoperative examinations. Two surgeons (DHKM and
CCS) performed all procedures. Inclusion criteria included
patient age ≥ 40 years, and healthy eyes with a
demonstrated loss of accommodative function. Participants had
less than 1.00 D of astigmatism measured in their manifest
refraction in each eye, and corrected distance visual acuity
(CDVA) equal to or better than 20/40 in each eye. Less
than 0.50 D difference existed between manifest and
cycloplegic refraction. Laser vision correction patients
were included (N = 4). Patients were excluded from this
study if they were pregnant or breast feeding, had previous
ocular surgeries other than laser vision correction, or had
a history of scleral ectasia, scleritis, or episcleritis. Patients
were accepted if they had an intraocular pressure (IOP)
between 11 and 30 mmHg and were not prescribed
pressure lowering medications. Fifty-two eyes of 26 patients
underwent the Laser Anterior Ciliary Excision (LaserACE)
Preoperative and postoperative assessments
The patients had a thorough eye examination including
objective and manifest visual acuity, IOP (pneumatic
tonometer), pupil size (neuroptics pupilometer),
keratometric measurements, slit lamp evaluation, stereoacuity
(Randot stereoscopic test), wavefront aberrometry
(Tracey Technologies), and fundoscopy. Regular
topographic patterns of the front and back cornea were
confirmed with a Pentacam-HR Scheimpflug camera
(Oculus, Inc.). Central corneal thickness was measured
with an optical low-coherence reflectometry
pachymeter and the Pentacam-HR tomographer. Scleral
thickness was measured for safety with dynamic,
highdefinition ultrasound biomicroscopy (Sonomed
Escalon) and only eyes with a calculated preoperative scleral
thickness of 400 μm or more were included.
Illuminated early treatment diabetic retinopathy study
(ETDRS) charts were used to assess visual acuity at
distance (4 m; 100% contrast ETDRS chart), intermediate
(60 cm; ETDRS visual acuity chart 2), and near (40 cm;
ETDRS visual acuity chart 1). Patients read down the
chart slowly, row by row, beginning with the first letter on
the top row. When the patients had difficulty reading a
letter they were encouraged to guess. The test ended when
it was evident that no further meaningful letter could be
identified, despite urging the subject to guess. Correctly
read letters were recorded on a score sheet with an
identical layout to that of the chart. The log minimum angle of
resolution (logMAR) score was calculated by adding the
logMAR of the best-read line to 0.1 logMAR, and
subtracting 0.02 logMAR units for each letter read. Photopic
lighting conditions were 85-90 cd/m2.
Device and surgical methods
An overview of the LaserACE surgical technique is
shown in Fig. 2. Two experienced LaserACE surgeons
performed all procedures bilaterally on the same day.
Prior to the procedure, topical
tobramycin/dexamethasone, and tetracaine, or equivalents of any of these three
eye drops, as well as diazepam or alprazolam orally, were
administered. Patients also received 1 drop of
brimonidine 0.15% every 10 min for 3 doses over 30 min prior
to surgery to reduce bleeding. Tetracaine and a third or
fourth generation fluroquinolone were applied to the
cornea prior to the procedure. An opaque corneal shield
was placed on the cornea, and remained in place until
the completion of the procedure.
An erbium: yttrium–aluminum–garnet (Er:YAG) laser
(VisioLite) was utilized to create micropores in the sclera.
The laser frequency was 10-30 Hz and laser fluence was
30-50 mJ/cm2. The spot size was 600 μm, delivered
through a fiber hand piece and near-contact 80° curved
tip. Excisions were placed in a matrix pattern from
0.5 mm from up to 6.0 mm from AL over the 3 critical
anatomical and physiological zones of significance.
Excision depth was 85-90% the depth of the sclera, to the
Fig. 2 LaserACE surgical technique. Photo a Quadrant marker; b Matrix marker; c Corneal Shield; d LaserACE micropore ablation; e Subconjunctival
Collagen; f Completed 4 quadrants
point that the blue hue of the choroid just became visible.
Each ablation began with a faster frequency of 30 Hz, and
slowed down to 10 Hz when approaching the deeper layer
so as not to penetrate the choroid.
A Collagen Matrix powder (Collawound,
Collamatrix) was mixed with a ratio of 1:4 (v/v) sterile saline
solution in a 10 mL syringe and applied directly over
the scleral ablation matrices with a cannula. An
18 mm scleral contact lens was routinely used
postoperatively to cover the ablation zones and hold the
collagen in place. Topical antibiotics and steroids
were used in both eyes, 4 times a day for 7 days,
followed by a steroid taper.
Patients were evaluated postoperatively on days 1, 3, 7,
and after 1, 3, 6, 12, 18, and 24 months.
Patient-reported visual function
The CatQuest 9SF Survey was used to investigate
patient satisfaction and patient-reported visual
function preoperatively and postoperatively at 6, 18, and
24 months .
Data were analyzed using repeated-measures analysis of
variance (ANOVA). Tukey honestly significant difference
post hoc comparisons were performed, where applicable.
A p < 0.05 was taken to be significant. The
measurements obtained at 1, 3, 6, 12, and 24 months were
included in the statistical tests.
Demographics and surgical information
Twenty-six subjects were enrolled, ranging in age from 45
to 64 years, and a mean age of 49.7 ± 4.37 years.
Twentyone patients completed 24 months of postoperative care.
Five patients withdrew, due to occupational travel conflicts.
Four patients were S/P laser vision corrected while the
remainders were naturally emmetropic (Table 1). Visual
outcomes in this study appeared to be very sensitive to corneal
refractive status. To understand the specific effects on visual
acuity, we chose to narrow the definition of ‘emmetropic’
by 0.25 D steps. Therefore, any patient that was close to 0
or between −0.25 D to +0.25 D we defined as true
Emmetropes and anything beyond −0.25 D to −0.5 D we defined
as emmetropic myopes. Likewise, any patient between
+0.25 D to +0.5 D we defined as emmetropic hyperopes.
Uncorrected visual acuity
Preoperative and postoperative monocular uncorrected
visual acuity (UVA) logMAR are shown in Fig. 3. The largest
improvements in visual acuity overall were for monocular
uncorrected near visual acuity (UNVA) measured at 40 cm.
Mean monocular UNVA for all patients was significantly
improved at all follow-up visits and was 0.25 ± 0.18
logMAR (~20/35 snellen) at 24 months postoperatively
compared to preoperative monocular UNVA of 0.36 ± 0.20
logMAR (~20/45 snellen) (p = 0.000050). Binocular UNVA
improved from +0.20 ± 0.16 logMAR (~20/32 snellen)
preoperatively, to +0.12 ± 0.14 logMAR (~20/25 snellen) at
24 months postoperatively (p = 0.0014).
Table 1 Preoperative patient demographics
Cylinder (mean ± SD)
−0.17 ± 0.14 D
LVC laser vision corrected, CDVA corrected distance visual acuity
Monocular uncorrected intermediate visual acuity
(UIVA) measured at 60 cm increased postoperatively for
all time points compared to preoperative UIVA, and was
statistically significant at 3 months postoperatively
(p = 0.0040). At 24 months postoperatively, there was no
statistically significant loss or change from preoperative
refraction. Similar to UIVA, monocular uncorrected
distance visual acuity (UDVA) measured at 4 m increased
at all time points and was statistically significant at 3
and 6 months postoperatively (p = 0.0080 and p = 0036).
Binocular UIVA increased for all points compared to
preoperative UIVA and was statistically significant at
3 months postoperatively (p = 0.0047). At 24 months
postoperatively, binocular UDVA showed no statistically
significant loss or change from preoperative refraction.
Distance corrected visual acuity
Preoperative and postoperative monocular distance
corrected visual acuity (DCVA) in logMAR are shown in Fig.
3. Similar to UVA, the largest improvements in visual acuity
were for distance corrected near visual acuity (DCNVA)
measured at 40 cm. Mean monocular DCNVA for all
patients was significantly improved (p = 0.000000019) at all
follow-up visits and was 0.21 ± 0.18 logMAR (~20/32
snellen) at 24 months postoperatively compared to preoperative
monocular DCNVA of 0.34 ± 0.18 logMAR (~20/45
snellen). Binocular DCNVA improved from +0.21 ± 0.17
logMAR (~20/32 snellen) preoperatively, to +0.11 ± 0.12
logMAR (~20/25 snellen) at 24 months (p = 0.00026).
Monocular distance corrected intermediate visual acuity
(DCIVA) measured at 60 cm increased postoperatively for
all time points compared to preoperative DCIVA, and was
statistically significant at 1, 3, 6, and 12 months
postoperatively (p = 0.0019, p = 0.00065, p = 0.000031, and
p = 0.0087). At 24 months postoperatively there was no
statistically significant loss or change from preoperative
refraction. Similar to DCIVA, monocular corrected distance
visual acuity CDVA measured at 4 m increased at all time
−0.30 ± 0.11 D
−0.15 ± 0.22 D
−0.19 ± 0.38 D
points and was statistically significant at 3 months
postoperatively (p = 0.015). Binocular DCIVA increased for all
points compared to preoperative DCIVA and was
statistically significant at 1, 3, 6, and 12 months postoperatively
(p < 0.0087). At 24 months postoperatively, binocular
CDVA showed no statistically significant loss or change
from preoperative refraction.
Stability, intraocular pressure, and stereopsis
The spherical equivalent refraction, shown in Fig. 4, was
stable over 24 months operatively. At 18 months
postoperatively, the spherical equivalent refraction was
significantly improved at 0.00 ± 0.46 D compared to
preoperative refraction 0.16 ± 0.42 D (p = 0.0015).
Intraocular pressure (IOP) as measured by pneumatic
tonometry is shown in Fig. 5. Patient IOP averaged of
13.56 ± 3.23 mmHg preoperatively. Patient IOP was
significantly lower than preoperative IOP at all time points apart
from 1 month postoperatively (p < 0.027). The average IOP
at 24 months postoperatively was 11.74 ± 2.64 mmHg and
was significantly improved from preoperative IOP
(p = 0.000063).
Stereopsis testing, as measured by Randot stereoscopic
tests, is shown in Fig. 6. Remarkably, stereoacuity improved
after the LaserACE procedure. This was statistically
significant at 18 months postoperatively (49.1 ± 16.9 s of arc;
p = 0.012). Preoperatively, mean stereoacuity was
75.8 ± 29.3 s of arc, which improved to 58.6 ± 22.9 s of arc
at 24 months, but was not statistically significant.
The results of the CatQuest 9SF patient-reported visual
function survey are shown in Fig. 7. Satisfaction scores
ranged from +2 indicating very satisfied to −2, very
dissatisfied. The mean patient satisfaction score and standard error
(SE) was −1.00 (SE = 0.22) preoperatively, significantly
improving to 0.33 (SE = 0.36) at 24 months postoperatively
(p = 0.000016). Patients indicated reduced difficulty in areas
Fig. 3 Uncorrected (lightly colored) and distance-corrected (darkly colored) visual acuity at distance (4 m) intermediate (60 cm), and near (40 cm)
for a) monocular and b) binocular patient eyes. Error bars represent mean ± SD
of near vision, and were overall satisfied with the procedure.
Responses ranged from +2 indicating no difficulty to −2,
great difficulty. The largest improvement in visual function,
as reported by patients, was during their handwork. This
improved from a mean rating of −0.15 (SE = 0.32)
preoperatively to 0.94 (SE = 0.34) at 24 months postoperatively
(p = 0.0052). Patients also rated large improvements in their
visual function when reading text in daily paper and seeing
prices while shopping at 24 months postoperatively. These
ratings were all statistically significant at all time points
postoperatively (p < 0.025). Patients rated very little
difficulty in areas of distance vision preoperatively, however
they all also reported improvement in distance vision as
well by 24 months postoperatively.
Representative photographs of postoperative patient
eyes are shown in Fig. 8. During the postoperative
period, the most common complaint was mild pain,
which relieved within 24 h. Some patients experienced
mild tearing, which decreased significantly after 1 week.
Very little to no red eye was reported, and was limited
to 1 day postoperatively. No ocular emergencies were
reported. Two patients had microperforation with
reduction in IOP to 5 mmHg and 8 mmHg, respectively, on
post-operative day 1. Both patients were managed with
collagen matrix application and a bandage soft contact
lens, after which IOP normalized by postoperative day 3
with no further complications. One patient had a
peripheral corneal abrasion due to accidental laser ablation to
Fig. 4 Box-and-whiskers plot of the stability of the spherical equivalent refraction of patient eyes. The upper and lower extremities of the box
represent the 75 and 25th percentiles, the bar within the box represents the median, the whiskers represent the full extent of the data ranges,
and the points represent outliers. The star denotes statistical significance compared to preoperative values
an area not completely covered by the corneal shield.
This resolved within 5 days. Throughout the whole
course of follow-up, there were no complications such
as persistent hypotony, cystoid macular edema, or loss
of distant best-corrected visual acuity (BCVA) in any of
LaserACE aims to restore near and intermediate visual
acuity in presbyopes by targeting the rigidity of the sclera
overlying the ciliary body in three critical zones of
anatomical and physiological significance [7, 8, 12, 16–19].
Limiting treatment to the sclera has several advantages
over other more invasive options to treat presbyopia. The
cornea remains untouched, as does the visual axis and
native crystalline lens. This reduces the risk of vision loss,
and allows LaserACE to be performed after or in
combination with other procedures. No implants are used, and
the surgery does not enter the eye. The procedure neither
precludes nor complicates future corneal or cataract
procedures. Moreover, for additive affect, LaserACE could
potentially be combined with other procedures such as
PresbyLasik or accommodative intraocular lenses (IOLs).
In addition, unlike scleral expansion bands, there are no
implants that may erode or extrude.
The positive results obtained at both near and
intermediate, given that this is a minimally invasive
procedure, are compelling. Changes in UNVA and DCNVA
Fig. 5 Box-and-whiskers plot of the postoperative changes in intraocular pressure (IOP) of patient eyes. The upper and lower extremities of the
box represent the 75 and 25th percentiles, the bar within the box represents the median, the whiskers represent the full extent of the data
ranges, and the points represent outliers. The stars denote statistical significance compared to preoperative values
Fig. 6 Box-and-whiskers plot of the stereoacuity of patient eyes. The upper and lower extremities of the box represent the 75 and 25th
percentiles, the bar within the box represents the median, the whiskers represent the full extent of the data ranges, and the points
represent outliers. The star denotes statistical significance compared to preoperative values
were statistically significant at each follow-up visit.
These results surpass early studies using scleral
expansion bands, whose results were inconsistent and
unpredictable, with a low level of patient satisfaction . A
recent study found that 93% of patient eyes had DCNVA
of 20/40 or better with the Visibility scleral implant .
Lens hardening in older patients may ultimately limit
Changes in monocular UDVA and CDVA were
statistically significant at 3 months for CDVA, and at 3 and
6 months for UDVA. Patients who still met the inclusion
criteria but were between 0 and +0.5 spherical
equivalent were labelled as ‘emmetropic hyperopes’. This was
done to distinguish these patients’ outcomes from the
emmetropic myopes since they behave differently when
accommodation is restored. We expect that patients
with any amount of hyperopia would receive a small
benefit in their distance vision, as the improved
accommodative ability in these patients after LaserACE could
be utilized to correct a small degree of hyperopia .
When the ‘emmetropic hyperope’ patients are removed
from our analyses, the statistically and clinically
significant changes in UDVA and CDVA are eliminated.
Other treatments addressing accommodation in
presbyopes include accommodating lenses and femtosecond lens
treatments. Accommodating lenses attempt to change the
Fig. 7 Average participant ratings from the CatQuest 9SF survey. Responses ranged from +2, indicating no difficulty, to −2, indicating great difficulty.
Error bars represent mean ± SE
Fig. 8 Serial photographs of representative patients from postoperative 1 week to 2 years
IOL position to facilitate near focus. Results have
reportedly been moderate, with mean low-contrast UNVA of
20/47 using the Crystalens . Near vision was better
with accommodating IOLs than monofocal IOLs, however
it was found in another study that this was at least partly
due to depth of focus rather than lens movement .
The femtosecond lens treatment used to facilitate the
change in the lens shape prior to cataract removal yielded
mild improvements at 1 month. Binocular DCNVA of
patients at 1 month increased 31 letters from baseline. In
addition, these treatments are more invasive than the
LaserACE technique, with an increased risk of vision loss
of between 1 and 2 lines .
All ranges of vision showed improvements in visual
acuity after LaserACE, with near tasks showing the largest
improvements through 24 months postoperatively. Both
DCNVA and UNVA had a similar trend of a peak at
6 months postoperatively, then a slight drop off between 6
and 12 months postoperatively. It is of interest to note
that the patients’ UVA and DCVA then begin to improve
at 12 months postoperatively and continued to improve
through 24 months postoperatively. This may be an
indication of neuroadaptation or a rehabilitative effect.
The improvements in stereopsis for our LaserACE
patients at 24 months postoperatively were both
surprising and remarkable, especially since all other
presbyopia treatments performed to date have diminished
stereopsis and binocularity [30–32]. Monovision, which
is either laser or contact lens induced, intentionally
decreases binocularity and stereopsis . Corneal
presbyopic correction attempts to create a bifocal cornea,
however the side effects include a loss of binocularity
and stereopsis . Accommodating IOLs potentially
could have limited effects on binocularity and
stereopsis, but as the surgery is quite invasive, they may be
more appropriate for cataract patients .
Our Taiwan IRB monitored clinical trial of the LaserACE
procedure utilizing the Er:YAG laser show promising
results for restoring the range of visual performance for
near, intermediate, and even far visual tasks in
emmetropic presbyopes without touching the visual axis or
compromising distance vision. The visual function and visual
acuity improvements at 24 months postoperatively were
clinically significant. Patient satisfaction was high
postoperatively and sustained over 24 months. Unlike other
presbyopia treatments, stereopsis was not only
preserved, but also improved over 24 months.
AL: Anatomical limbus; BCVA: Best-corrected visual acuity; CDVA: Corrected
distance visual acuity; DCIVA: Distance corrected intermediate visual acuity;
DCNVA: Distance corrected near visual acuity; DCVA: Distance corrected visual
acuity; Er:YAG: Erbium: yttrium–aluminum–garnet; ETDRS: Early treatment diabetic
retinopathy study; IOL: Intraocular lens; IOP: Intraocular pressure; IRB: Institutional
review board; LaserACE: Laser anterior ciliary excision; logMAR: Logarithm of
minimum angle of resolution; SD: Standard deviation; SE: Standard error;
UDVA: Uncorrected distance visual acuity; UIVA: Uncorrected intermediate visual
acuity; UNVA: Uncorrected near visual acuity; UVA: Uncorrected visual acuity
Availability of data and materials
Data from this study is available from the corresponding author upon request.
AMH and MJ conceived and designed the study. AMH, DM, and CCS
collected and analyzed the data. AMH, DM, CCS, and BH provided
statistical analysis. AMH, DM, CCS, DG, and BH provided critical revision
of the manuscript. AMH and MJ provided supervisory support. AMH and
BH drafted the manuscript. All authors read and approved the final
AMH reports personal fees and non-financial support from Ace Vision
Group Inc. during the conduct of the study. In addition, Dr. Hipsley has
a patent (no. 7871404) issued to Ace Vision Group Inc., a patent (no.
8348932) issued to Ace Vision Group, Inc., a patent (no. 20150157406)
pending to Ace Vision Group, Inc., a patent (no. 20140316388) pending
to Ace Vision Group, Inc., a patent (no. 20140163597) pending to Ace
Vision Group, Inc., a patent (no. 20120165849) pending to Ace Vision
Group, Inc., a patent (no. 20110190798) pending to Ace Vision Group,
Inc., a patent (no. 20080058779) pending to Ace Vision Group, Inc., and
a patent (no. 20070016175) pending to Ace Vision Group, Inc.
MJ reports personal fees and non-financial support from Ace Vision Group
Inc., during the conduct of the study; personal fees from Bausch & Lomb,
personal fees from Allergan, outside the submitted work.
DM and CCS report non-financial support from Ace Vision Group Inc., during
the conduct of the study.
BH and DG report personal fees from Ace Vision Group Inc. during the
conduct of the study.
Consent for publication
Patients provided written consent for imaging and publication of personal
identifying information including medical record details.
Ethics approval and consent to participate
Data presented were obtained from IRB monitored and registered
international clinical pilot studies, which followed the tenets of the
Declaration of Helsinki.
AnnMarie Hipsley, DPT, PhD, Employee, Ace Vision Group
David Hui-Kang Ma, MD, PhD, no disclosures
Chi-Chin Sun, MD, PhD, no disclosures
Mitch Jackson, MD, Consultant to Ace Vision Group
Daniel B Goldberg MD, Consultant to Ace Vision Group
Brad Hall, PhD, Consultant to Ace Vision Group
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