Monopolar Radiofrequency Treatment of the Eyelids:

A Safety Evaluation
BRIAN S. BIESMAN, MD, FACS,AND KARL POPE, MSy

BACKGROUND Monopolar radiofrequency (RF) energy has been used to successfully accomplish non-
invasive skin tightening of the face, abdomen, and extremities. Owing to concerns about injury to the
eye itself, monopolar RF treatment of the eyelids has not been feasible.
OBJECTIVE The objective was to evaluate the safety of a novel 0.25-cm 2 ‘‘shallow’’ treatment tip for
noninvasive tightening of eyelid skin.
METHODS AND MATERIALS This was a tripartite study that began with an animal model to evaluate soft
tissue effects and temperature change at the ocular surface. Findings were then extrapolated to ex vivo
evaluation of human eyelids and ultimately to an in vivo human eyelid safety study.
RESULTS The animal studies demonstrated that the 0.25-cm 2 treatment tip could be used safely on
eyelids in conjunction with appropriate ocular protection. The ex vivo human eyelid studies confirmed
that, at typical treatment settings, the shallow treatment tip did not produce frank eyelid injury. The
in vivo human studies confirmed that, at the tested settings, the novel treatment tip did not injure
the eyelids or eyes.
CONCLUSION If used properly, the 0.25-cm 2 treatment tip can be safely used on human eyelids.
Karl Pope is an employee of Thermage, which supplied the treatment tips for the study. Dr Biesman is a
consultant for Thermage Inc.

A esthetic periorbital rejuvenation is one of the

most commonly sought after aesthetic goals.
Anatomic changes occurring in this region with
aging include laxity of eyelid skin, ‘‘hypertrophic’’
orbicularis oculi muscle, prominent orbital fat pads,
and even descent of the forehead, eyebrows, and
midface. Patients typically interpret these anatomic
changes as making them look ‘‘old’’ or ‘‘tired.’’ Re-
juvenation of the periorbital region has traditionally
been limited to surgery of the eyelids, forehead, or
midface. In the early 1990s, botulinum toxin type A
began to gain widespread popularity for modifying
the orbicularis oculi muscle and, more recently, fill-
ing agents such as hyaluronic acid have been injected
into the periorbital region to camouflage the volume
deficit produced by descended midfacial structures.
Because each of these techniques complements one
another, they all can play an important role in pe-
riorbital rejuvenation. The fact that botulinum toxin
injection has become the most popular aesthetic
procedure suggests that many patients are interested
in pursuing nonsurgical rejuvenation options. To
date, such an option does not exist for tightening or
rejuvenating eyelid skin.
The benefits of radiofrequency (RF)-induced skin
tightening have been well recognized.1–4 A com-
mercially available RF device (ThermaCool,
Thermage Inc., Hayward, CA) uses a 6-MHz RF
generator to capacitively couple energy through a
monopolar treatment tip to produce volumetric
tissue heating. This heating leads to an immediate
conformational change in dermal collagen, tighten-
ing of the fibrous septae extending from the dermis
to the subcutaneous tissue, and stimulation of
dermal neocollagenesis (K. Pope, M. Levinson, and

Departments of Ophthalmology, Otolaryngology, and Dermatology, Vanderbilt University Medical Center, Nashville,
Tennessee; yThermage, Inc., Hayward, California

& 2007 by the American Society for Dermatologic Surgery, Inc.
Published by Blackwell Publishing

ISSN: 1076-0512
Dermatol Surg 2007;33:794–801
DOI: 10.1111/j.1524-4725.2007.33172.x

794

E. V. Ross, personal communication, February
2005). The ThermaCool has FDA clearance for skin
tightening of the face, neck, and body. To tighten the
skin in these regions, RF energy is delivered via dis-
posable treatment tips approximately 2 to 3 mm
beneath the skin’s surface. It follows from the ex-
perience in other anatomic regions that delivery of
RF energy to the eyelids may produce favorable
aesthetic outcomes. Owing to the thin nature of the
eyelid, the use of the existing treatment tips on the
eyelids may put deeper structures in the eyelid or
even the eye itself at risk of injury. We therefore
sought to develop a new treatment tip with the
capability of delivering monopolar RF energy to the
eyelids in such a manner that favorable aesthetic
outcomes could be achieved without posing a risk to
the eye. To this end, a novel 0.25-cm2 (0.5  0.5-cm)
treatment tip for the ThermaCool device was devel-
oped by Thermage, Inc. (Figure 1). This tip was
modeled to have a penetration depth of 1.2 mm, the
level at which the electric field drops to 1/e (B37%)
of the surface energy. The testing process for this tip
involved four distinct stages: animal testing, treat-
ment of ex vivo human eyelid skin, treatment of in
vivo human eyelid skin immediately before surgical
excision, and finally clinical efficacy. This article will
describe the first three stages of this testing process;
clinical efficacy studies will be described separately.
Methods
Phase I: Animal Study
A farm piglet model was selected for the relative
similarity between piglet and human eyelids.
Figure 1. 0.25-cm2 ‘‘shallow’’ treatment tip.
BIESMAN AND POPE
Figure 2. Dose response: Effect of 0.25-cm2 treatment levels
on piglet eyelid skin. Numbers represent treatment level,
not fluence. Note that erythema persists more than 1 hour at
higher treatment levels.
Appropriate institutional review board (IRB) ap-
proval was obtained and all animal care guidelines
were followed. General anesthesia was administered
to a farm piglet weighing approximately 15 kg. A
return pad was placed on the back, and the upper
and lower eyelids were divided into multiple equal-
sized sections with a surgical marker (Figure 2).
Ophthalmic examination was performed with a
hand-held slit lamp before the initiation of studies.
A plastic corneoscleral protective lens was placed
behind the eyelids, and each section of the eyelid was
treated with RF energy at a different fluence. Initially
a dose–response type of study was performed, de-
livering single-pulse treatment over a wide range of
energies from very low to extremely high. Fluences
used in this portion of the study ranged from 40 to
93 J/cm2 (10–23 J). On the animal’s opposite side,
studies were performed to evaluate the clinical ef-
fects of multiple-pass treatment application and to
determine the peak temperature produced at the
ocular surface with a plastic corneoscleral lens
(Oculo-Plastik, Montreal, Canada) in place. The
latter studies involved the use of a custom-designed
corneoscleral lens with a thermocouple embedded in
the posterior aspect of the lens (Figure 3). The
thermocouple was connected to a computer that
measured temperature 1,000 times/second. Tem-
perature change was measured with single-pulse en-
ergy delivery over a range of fluences, after multiple
passes allowing for cooling between passes, and then
in a pulse-stacking manner at fluences high enough
to produce frank epidermal injury (Figures 4 and 5).
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 M O N O P O L A R R F E Y E L I D T R E AT M E N T
Figure 3. Corneoscleral protective lens with embedded thermocouple in position (A) and before insertion (B).
The latter measurements were taken at settings well
above those expected to be used clinically without
allowing time for the skin to cool between passes in
an effort to assess ocular risk under the most dire
conditions. Ophthalmic examination was repeated
with a hand-held slit lamp at the conclusion of the
treatment. Before euthanization, the animal cornea
was treated directly with the ThermaCool device to
assess the outcome of a catastrophic clinical error
(Figure 6). Finally, the eyelids were harvested for
histopathologic evaluation, and the eyes were enu-
cleated. Histopathologic analysis of the eyelid skin
and globe was performed using standard hematox-
ylin and eosin stains.
Phase II: Ex Vivo Analysis of Human Eyelid Skin
After obtaining IRB approval of the proposed pro-
tocol and informed consent from all patients,
10 eyelids of five patients undergoing routine upper
Figure 4. Thermocouple measurements taken at corneal
surface during two passes at 35.5. Pulses were delivered
without pulse staking. Note that peak temperature was well
below the injury threshold.
796 D E R M AT O L O G I C S U R G E RY
eyelid blepharoplasty were harvested. Immediately
after the conclusion of the surgical case, the lids were
prepared for treatment with the ThermaCool device
using the 0.25-cm2 treatment tip. To simulate an RF
treatment on the eyelid, a rubber mold in the shape
of the eye was made. This simulated the non-
conducting surface of the corneoscleral lens that is
used to protect the eye. To replicate the attachment
of the eyelid to the rest of the body, a moistened
towel was placed in a saline bath, draped over the
rubber mold and under the lid. Aluminum foil was
used to create a ‘‘return pad’’ that was, in turn,
connected to the RF generator to complete the
circuit (Figure 7). The RF generator delivered 68 or
76 J/cm2, a fluence extrapolated from the piglet data,
to treat the eyelids in a single pass without pulse
Figure 5. Thermocouple measurements taken at corneal
surface during two passes at a setting of 38.5. This is well
above energy setting that would be tolerated clinically.
Pulses were delivered with a pulse-stacking technique to
simulate a ‘‘worst-case scenario.’’ Note that peak tempera-
tures remain well below the ocular injury threshold even
under extreme conditions.

Figure 6. Enucleated eye demonstrating corneal stromal opacification in outline of ThermaCool treatment tip after delivery
of RF energy directly to the cornea.
overlap. Three eyelids were treated at 68 J/cm2,
6 eyelids were treated at 76 J/cm2, and 1 served as
a control. The tissue was then placed in 10%
formalin solution and processed for histopathologic
evaluation.
Phase III: In Vivo Treatment of Human
Eyelid Skin
After obtaining IRB approval of the proposed
protocol and informed consent from all patients,
20 eyelids from 10 patients undergoing routine up-
per eyelid blepharoplasty and/or blepharoptosis re-
pair were selected to participate in this phase of the
study. A drop of 0.5% proparacaine solution was
placed in each eye, and a plastic corneoscleral pro-
tective lens (Oculo-Plastik) was placed behind the
eyelids. Ellipses were marked on the eyelids to de-
note the proposed area of skin removal. A return pad
was applied to the abdomen, and the coupling fluid
Figure 7. Experimental design permitting evaluation of ex
vivo human eyelid skin.
BIESMAN AND POPE
provided for use in other anatomic regions
was applied liberally to the eyelids. Patients were
treated with the ThermaCool device using the
0.25-cm2 treatment tip at fluences ranging from
68 to 100 J/cm2. The fluence was increased until the
patients reported subjective perception of discomfort
of 2 to 2.5 on a 0 to 4 scale. Up to five passes were
performed. Pulses were applied in a nonoverlapping
fashion and pulse stacking was avoided. The treated
skin was allowed to cool a full 2 minutes between
passes, and treatment was only delivered to skin
scheduled for immediate excision. Neither topical,
regional, nor systemic anesthetic agents were used
before ThermaCool treatment. The patients were
then sedated with intravenous diprivan and local
anesthesia 2% lidocaine with epinephrine was in-
jected into the eyelids in standard fashion for the
blepharoplasty. The ellipses of treated skin were
harvested, and the planned procedure completed.
The excised tissue was placed immediately into 10%
buffered formalin solution for histopathologic
analysis. A baseline ophthalmic examination was
performed before and after treatment.
Results
Phase I: Animal Study
Application of single pulses at very low fluences
produced no visible change in the eyelid appearance
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 M O N O P O L A R R F E Y E L I D T R E AT M E N T

TABLE 1. The Histologic Findings at Different Energy Levels on Bovine Eyelids

Eyelid Joules J/cm2 Histology

Left
L1 10 40 No findings
L2 13 52 No findings
L3 14 57 No findings
L4 16 64 No findings
L5 17 69 No findings
L6 20 81 0–1 (minimal superficial dermal inflammation)
L7 22 89 2
L8 23 93 2 1 (larger subepidermal blister than L7)
L9 0 0 ControlFno findings
Right
R1 10 40 No findings
R2 13 53 No findings
R3 16 64 No findings
R4 19 76 No findings
R5 22 88 No findings
R6 23 92 No findings
R7 23 92 No findings
Positions 1–6 were on the upper lid; higher numbers were on the lower lids.

while delivery of high energy pulses produced nearly
immediate erythema and, in some cases at 92 J/cm2,
blistering (Table 1; Figure 2). These treatment levels
are no longer available with this treatment tip. Ex-
trapolating from these data helped suggest the pa-
rameters to be used in Phase II, treatment of ex vivo
human eyelid skin. These parameters were further
refined by multiple-pass treatment of the opposite
eyelids. When multiple-pulse techniques (allowing
cooling time between passes and pulse stacking)
were employed at moderate energy settings, little or
no clinical changes were apparent. Mild erythema
was intermittently noted after pulse stacking at
moderate energy. No frank epidermal injury was
noted with either technique at these lower energy
settings. Histopathologically, there was no evidence
of injury or thermal effect to the epidermis, dermis,
or orbicularis oculi muscle at low to moderate en-
ergy settings. Only when the pulse energy was high
enough to produce immediate frank epidermal injury
did histopathologic changes consistent with thermal
injury become apparent. At these settings, histo-
pathologic analysis revealed epidermal necrosis
without obvious dermal injury. Occasional dermal
sections were suggestive of early thermal change
(coagulative necrosis), but this was not a consistent
finding even at fluences high enough to produce
immediate epidermal injury.
Temperature change at the ocular surface was
assessed during single-pulse application, during
delivery of multiple passes performed at 2-minute
intervals, and while a pulse-stacking technique was
utilized. At low to moderate energy settings using
single- or multiple-pass technique at moderate
energy settings as would typically be used clinically,
the temperature rise at the corneal surface was small.
To create a worst-case scenario, pulse stacking
was performed at energy levels high enough
to create immediate whitening and blistering of the
epidermis. Under these extreme conditions, the
temperature elevated with successive passes
but peaked at just over 461C. Attempts to drive
the ocular surface temperature higher with the
ThermaCool device applied to the eyelids were
unsuccessful. Finally, deliberate application
of the treatment tip to the ocular surface at moderate
energy setting produced immediate corneal
opacification in the shape and size of the treat-
ment tip electrode.

798 D E R M AT O L O G I C S U R G E RY

Figure 8. Ex vivo human eyelid skin treated at 76 J/cm2. At low power (100  , A) an area of slightly increased eosinophilia is
observed although the epidermis remains intact. Examination of the designated area under higher power (400  , B) reveals
changes that my be consistent with early coagulative necrosis.
Posttreatment ophthalmic examination of the piglet
eyes, including evaluation with a portable slit lamp,
was unchanged from the initial baseline. There was
no evidence of thermal injury to the conjunctiva,
cornea, or lens except as noted for direct treatment
to the cornea.
Phase II: Ex Vivo Analysis of Human Eyelid Skin
Clinical changes were not noted after treatment of
the excised human eyelid skin. The epidermis re-
mained intact without whitening or discoloration.
Histopathologic evaluation of the nine treated lids
revealed no change in six of nine lids. Limited re-
gions of one lid treated at 68 J/cm2 and two lids
treated at 76 J/cm2 demonstrated changes suggestive
of mild thermal injury (Figure 8). This change was
not felt to be clearly indicative of thermal injury
because it was not found consistently through the
affected specimens and was absent in a majority of
specimens treated. An artifact of tissue processing or
handling could not be eliminated.
Phase III: In Vivo Treatment of Human
Eyelid Skin
Because this represented the first in vivo eyelid
treatment, the question of patient tolerance was of
primary significance. Without exception, all treat-
ments were well tolerated. Treatment settings were
BIESMAN AND POPE
adjusted until subjective sensation of discomfort was
rated 2.0 to 2.5 on a 0 to 4 scale. Mild erythema and
slight edema were present after some treatments but
there were no instances of crusting, blistering, or
deeper thermal injuries. Of equal significance, when
the planned procedure was subsequently performed,
all eyelid structures including the orbicularis muscle,
orbital septum, orbital fat, levator palpebrae super-
ioris muscle, Müller’s muscle, and tarsus were nor-
mal in appearance and integrity. All patients had an
uneventful postoperative course without complica-
tions. Because only a limited ellipse of upper eyelid
skin was scheduled for excision, skin tightening was
not assessed. Histopathologic analysis of all 20 eye-
lids with hematoxylin and eosin staining failed to
demonstrate epidermal injury or dermal coagulative
necrosis. With the exception of the anticipated
changes induced by routine upper eyelid surgery,
the postoperative ophthalmic examination was un-
changed relative to the baseline taken preoperatively.
Discussion
Although the skin-tightening effects of monopolar
RF energy have been well established, RF treatment
of the eyelids has not been previously attempted. On
account of the thin nature of the eyelid, it was felt
that heating the lids with a device that has an elec-
trical penetration depth of approximately 2.5 mm
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 M O N O P O L A R R F E Y E L I D T R E AT M E N T
could put the eye in jeopardy. These concerns ori-
ginated from previous reports of the effects of RF
energy on both human and animal eyes. Unfortu-
nately none of these prior studies compare directly to
the nature of the energy delivered with the Therma-
Cool RF generator. Cataractous opacification of the
crystalline lens has been observed in experimental
animals when one eye was exposed to a localized,
very high RF field and the other eye was the unex-
posed control. Results of these studies demonstrated
that 2,450-MHz exposures for more than 30 minutes
at power densities causing extremely high dose rates
(4150 W/kg) and temperatures of greater than 411C
in or near the lens caused cataracts in the rabbit eye.
Cataracts were not observed in the monkey eye ex-
posed to similar exposure conditions, however. Be-
cause the monkey head is similar in structure to the
human head, the nonhuman primate study showed
that the incident power density levels causing catar-
acts in rabbits and other laboratory animals cannot
be directly extrapolated to primates including hu-
mans. It is reasonable to assume that prolonged ex-
posure of humans to RF energies that would produce
heating of the lens to greater than 411C would be
cataractogenic; however, such exposure would be
expected to cause thermal injuries to other parts of
the eye, particularly the conjunctiva and cornea.5
Such injuries were not observed in either our animal
model or in the in vivo human study. While retinal
and lenticular injuries have been reported in animal
models and in vitro studies of human ocular expos-
ure to microwave radiation, the dosage and/or
duration of radiation in these scenarios does not
correlate with the brief exposure sustained during
ThermaCool treatment of the eyelids.6–12 Further,
over the range of fluences tested in our in vivo pro-
tocol, minimal discomfort was reported in the eye-
lids and no patient reported actual ocular pain. This
suggests that temperature at the ocular surface did
not rise above 38 to 391C, confirming our experi-
mental data generated with the thermocouple in the
piglet model.5 With substantial heating of the cor-
nea, thermal modification of the stromal collagen
can result in refractive change. This trait is capital-
ized upon in RF conductive keratoplasty, a refractive
800 D E R M AT O L O G I C S U R G E RY
surgery technique in which the corneal contour is
steepened to reduce hyperopia. Although estimates
of corneal temperature change have previously
suggested peak temperatures of 65 to 701C, finite
element computer models suggest that actual tem-
peratures reached may exceed 1001C.13 Because
none of the patients treated in our study experienced
ocular pain or developed a change in visual acuity or
refractive error after RF treatment of the eyelids with
a corneoscleral shield in place, it is reasonable to
assume that the temperature at the ocular surface did
not rise high enough to induce changes in corneal
topography. With direct application of the RF elec-
trode to the piglet cornea, immediate thermal
changes due to denaturation of collagen were ob-
served clinically and were confirmed histologically14
(Figure 8).
Our observation that there was no frank coagulative
necrosis in the dermis of either the animal or human
eyelid tissue is consistent with observations made by
Zelickson and colleagues.1 These authors did not
observe morphologic changes using light microscopy
between treated skin and controls. Studies by other
authors in which clinically apparent skin tightening
has been produced have also demonstrated no ap-
parent immediate changes in treated tissue at the
light microscopic level.15
Conclusion
This study represents the first evaluation of the 0.25-
cm2 ‘‘shallow’’ treatment tip intended for use on and
around the eyelids. The goals of this study were only
to evaluate the safety of this device relative to the
eyelid skin, delicate structures within the eyelid, and
the eye itself and to determine patient acceptance of
this technique. From our data, we believe that the
ThermaCool RF generator may be used safely on the
eyelids in conjunction with the 0.25-cm2 treatment
tip and adequate ocular protection with a plastic
corneoscleral lens in place. Extrapolation to clinical
outcomes; recommended treatment algorithms; and
combination with other treatment options such as
botulinum toxin, fillers, surgery, or others cannot be

made. Additional studies to evaluate efficacy and
clinical outcomes are under way.
References
1. Zelickson BD, Kist D, Bernstein E, et al. Histological and ultra-
structural evaluation of the effects of a radiofrequency-based
nonablative dermal remodeling device: a pilot study. Arch Der-
matol 2004;140:204–9.
2. Koch RJ. Radiofrequency nonablative tissue tightening. Facial
Plast Surg Clin North Am 2004;12:339–46, vi.
3. Fitzpatrick RE, Geronemus R, Goldberg D, et al. First multi-
center study of a new non-ablative radio frequency device to
tighten facial tissue. Lasers Surg Med 2003;32(Suppl 15):35.
4. Alster TS, Tanzi E. Improvement of neck and cheek laxity with a
nonablative radiofrequency device: a lifting experience. Dermatol
Surg 2004;30(4 Pt 1):503–7.
5. Elder JA. Ocular effects of radiofrequency energy. Bioelectro-
magnetics 2003;24(Suppl 6):148–61.
6. Birenbaum L, Grosof GM, Rosenthal SW, Zaret MM. Effect of
microwaves on the eye. IEEE Trans Biomed Eng 1969;16:7–14.
7. Birenbaum L, Kaplan IT, Metlay W, et al. Effect of microwaves on
the rabbit eye. J Microwave Power 1969;4:232–43.
8. Chou CK, Guy AW, Borneman LE, et al. Chronic exposure of
rabbits to 0.5 and 5 mW/cm2 CW microwave radiation. Bioelec-
tromagnetics 1983;4:63–77.
BIESMAN AND POPE
9. Creighton MO, Larsen LE, Stewart-DeHaan PJ, et al. In vitro
studies of microwave-induced cataract. II. Comparison of damage
observed for continuous wave and pulsed microwaves. Exp Eye
Res 1987;45:357–73.
10. Foster MR, Ferri ES, Hagan GJ. Dosimetric study of microwave
cataractogenesis. Bioelectromagnetics 1986;7:129–40.
11. Kramar P, Harris C, Emery AF, Guy AW. Acute microwave
irradiation and cataract formation in rabbits and monkeys.
J Microwave Power 1978;13:239–49.
12. Kues HA, D’Anna SA, Osiander R, et al. Absence of ocular
effects after either single or repeated exposure to 10 mW/cm2
from a 60 GHz source. Bioelectromagnetics 1999;20:
463–73.
13. Beuerman RW, Tanelian DL. Corneal pain evoked by thermal
sensation. Pain 1979;7:1–14.
14. Berhano EJ. Modeling for radiofrequency conductive keratoplas-
ty. implications for the maximum temperature reached in the
cornea. Physiol Meas 2005;26:157–72.
15. Abraham MT, Ross EV. Current concepts in nonablative radio-
frequency rejuvenation of the lower face and neck. Facial Plast
Surg 2005;21:65–73.
Address correspondence and reprint requests to: Brian S.
Biesman, MD, 345 23rd Avenue North, Suite 416, Nash-
ville, TN 37203, or e-mail: bbies@mindspring.com
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