Group Title: BMC Ophthalmology
Title: Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery
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 Material Information
Title: Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery
Physical Description: Book
Language: English
Creator: Chalam, K. V.
Murthy, Ravi
Agarwal, Swati
Gupta, Shailesh
Grover, Sandeep
Publisher: BMC Ophthalmology
Publication Date: 2009
 Notes
Abstract: BACKGROUND:To compare the clinical efficacy of lidocaine 2% with tetracaine 0.5% for cataract surgery.METHODS:In a randomized, multi-surgeon, controlled clinical trial,122 consecutive cataract cases eligible for topical anesthesia, were randomly assigned to receive lidocaine 2% gel (1 ml) or tetracaine solution 0.5% (TetraVisc, 0.5 ml) before clear corneal phacoemulsification. Main outcome measure was visual analog scale (0 to 10), which was used to measure intra-operative pain. Secondary outcome measures included patients' discomfort due to tissue manipulation and surgeon graded patients' cooperation. Duration of surgery and intra-operative complications were also recorded.RESULTS:The mean age in TetraVisc (TV) group was 70.4 years and in the lidocaine gel group (LG) it was 70.6 years (p = 0.89). Patient reported mean intra-operative pain scores by visual analog scale were 0.70 ± 0.31 in TV group and 1.8 ± 0.4 in LG group (P < 0.001). Mean patient cooperation was also marginally better in the TV group (8.3 ± 0.3) compared to LG group (8.4 ± 0.6) (P = 0.25). 96% of patients in TV group showed intra-operative corneal clarity compared to 91% in LG group. TV group had less (1 out of 61 patients, 1.6%) intra-operative complications than LG group (3 out of 61 patients, 4.8%). No anesthesia related complications were noted in either groupCONCLUSION:Topical TetraVisc solution was superior to lidocaine 2% gel for pain control in patients undergoing clear corneal phacoemulsification. Lidocaine 2% gel is similar to TetraVisc in patient comfort and surgeon satisfaction.TRIAL REGISTRATION:Clinical trials number: ISRCTN78374774
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General Note: M3: 10.1186/1471-2415-9-7
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Research article

Comparative efficacy of topical tetraVisc versus lidocaine gel in
cataract surgery
KV Chalam*, Ravi K Murthy, Swati Agarwal, Shailesh K Gupta and
Sandeep Grover


Address: Department of Ophthalmology, University of Florida College of Medicine, Jacksonville, Florida, USA
Email: KV Chalam* kvchalam@aol.com; Ravi K Murthy- ravi.keshavamurthy@jax.ufl.edu; Swati Agarwal swati.agarwal@jax.ufl.edu;
Shailesh K Gupta shailesh.gupta@jax.ufl.edu; Sandeep Grover sandeep.grover@jax.ufl.edu
* Corresponding author



Published: 17 August 2009 Received: 15 December 2008
BMC Ophthalmology 2009, 9:7 doi: 10.1186/1471-2415-9-7 Accepted: 17 August 2009
This article is available from: http://www.biomedcentral.com/1471-2415/9/7
2009 Chalam et al; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0),
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.



Abstract
Background: To compare the clinical efficacy of lidocaine 2% with tetracaine 0.5% for cataract
surgery.
Methods: In a randomized, multi-surgeon, controlled clinical trial, 122 consecutive cataract cases
eligible for topical anesthesia, were randomly assigned to receive lidocaine 2% gel (I ml) or
tetracaine solution 0.5% (TetraVisc, 0.5 ml) before clear corneal phacoemulsification. Main
outcome measure was visual analog scale (0 to 10), which was used to measure intra-operative
pain. Secondary outcome measures included patients' discomfort due to tissue manipulation and
surgeon graded patients' cooperation. Duration of surgery and intra-operative complications were
also recorded.
Results: The mean age in TetraVisc (TV) group was 70.4 years and in the lidocaine gel group (LG)
it was 70.6 years (p = 0.89). Patient reported mean intra-operative pain scores by visual analog scale
were 0.70 0.31 in TV group and 1.8 0.4 in LG group (P < 0.001). Mean patient cooperation was
also marginally better in the TV group (8.3 0.3) compared to LG group (8.4 0.6) (P = 0.25). 96%
of patients in TV group showed intra-operative corneal clarity compared to 91% in LG group. TV
group had less (I out of 61 patients, 1.6%) intra-operative complications than LG group (3 out of
61 patients, 4.8%). No anesthesia related complications were noted in either group
Conclusion: Topical TetraVisc solution was superior to lidocaine 2% gel for pain control in
patients undergoing clear corneal phacoemulsification. Lidocaine 2% gel is similar to TetraVisc in
patient comfort and surgeon satisfaction.
Trial Registration: Clinical trials number: ISRCTN78374774



Background peribulbar, subconjunctival, sub-Tenon's) and topical
Cataract surgery is the most frequently performed surgical anesthesia [1-71. Topical anesthesia has gained popularity
procedure in USA. Common forms of local anesthesia for in recent years, as it has been shown to be safe and effec-
cataract surgery include injection techniques (retrobulbar, tive method of anesthesia. The main advantages of using


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topical over injectable anesthetics are avoidance of risks
and complications associated with injections, improved
patient comfort with faster recovery, and lack of pain dur-
ing administration [6,7]. Topical anesthetics can be used
as drops, gel or intracameral injection in cataract surgery.
Gel anesthesia with lidocaine 2% has shown higher int-
racameral levels of lidocaine, better analgesia, better
patient cooperation and less need for intraoperative anal-
gesia over lidocaine 4% topical drops [8]. Prolonged con-
tact time and lubricating effectof gel anesthesia leads to
increased efficacy and avoids the need for frequent cor-
neal wetting. The disadvantages for the lidocaine gel are
that its use demands several doses of administration, has
short anesthetic effect, and at times obscures the view dur-
ing capsulorrhexis or at the end of cataract procedure [9].

TetraVisc hydrochloride 0.5%, a new viscous topical agent
induces rapid anesthesia as it disperses across the cornea
rapidly and immediately and offers an extended period of
anesthetization due to prolonged contact time [10].

Using a 10-point visual analog pain scale, we evaluated
the efficacy of TetraVisc 0.5% solution (TV) and lidocaine
gel 2% (LG) in a randomized study in patients undergo-
ing phacoemulsification with intraocular lens implanta-
tion.

Methods
The study was approved by Institutional Review Board/
Ethics Committee of University of Florida. 122 patients
scheduled for elective cataract surgery and eligible for top-
ical anesthesia were included in the study. Exclusion crite-
ria were unwillingness to have topical anesthesia, high
anxiety, dementia or mental instability, deafness, move-
ment disorders, hyperanxiety, and inability to complete
the visual analog scale (VAS) of pain line (for example,
confusion, communication barriers, visual impairment)
and any reported allergy to lidocaine or tetracaine. All
patients were recruited between January 2006 and
November 2006.

The patients were randomized by block randomization
(randomly assigned by computer generated numbers) to
receive either TetraVisc (Tetracaine hydrochloride 0.5%,
OCuSOFT) solution or lidocaine gel (Xylocaine 2% jelly,
Astra) consecutively. Five doses of TV or LG were applied
every 5 minutes, 20 minutes prior to surgery. No intrave-
nous or oral sedation was used as pre-medication.

Surgical Procedure
Ofloxacin was administered by the patient for 3 days pre-
operatively in the eye to be operated. Mydriasis was
obtained preoperatively with phenylephrine hydrochlo-
ride, 2.5% (EyePhrine, Eye Supply, USA) and tropica-
mide, 1% (EyeMed, Eye Supply, USA) eye drops. In the


operating room, baseline pulse and peripheral blood
pressure were taken. The lid and periorbital skin were
cleaned and the conjunctival cul-de-sac was irrigated with
povidone iodide solution. The eye was then draped, and
an open-wire speculum was placed. Before the surgeon sat
at the operating microscope and began the procedure, the
eye was irrigated with balanced salt solution to eliminate
lidocaine gel or other anesthetic remnants. The surgical
procedure was carried out as a clear corneal phacoemulsi-
fication using a superior incision by the phaco chop tech-
nique. Balanced salt solution was used for automated
irrigation-aspiration. Foldable intraocular lenses (IOL)
were implanted. During the surgery, the surgeon was in
constant communication with the patients and frequently
asked them if they wished to have additional anesthesia.
If breakthrough pain occurred in either group during sur-
gery, supplemental topical anesthesia was administered.

Primary Outcome Measures
After the completion of surgery, the patients were accom-
panied to the recovery room and were asked to grade
intra-operative pain using a 0 to 10 visual analog scale
(VAS) within 10 minutes of completion of surgery. The
patient and independent observer were masked to the
anesthesia used.

Secondary Outcome Measures
An independent observer also collected surgeons'
responses to complete a ten point satisfaction scale imme-
diately after each surgery rating the overall surgical experi-
ence. The surgeons were requested to consider not only a
subjective impression of patient comfort and ease of sur-
gery but also the presence of inadvertent eye movements,
patient reported painful sensations (including pain dur-
ing the administration of the anesthetic), lid squeezing,
and intra-operative complications when providing an
overall score. The final score was a general estimate con-
sidering all these variables. The scale used rated the surgi-
cal experience as 0-10 where 0 is poor cooperation and 10
is excellent cooperation. The need for supplemental
anesthesia was recorded. Further information recorded
included: patient demographics, operative technique,
quantity and type of sedative administered, and volume
of anesthetic used for supplemental anesthesia. The power
of this study was 92% using a sample size of 61 patients
to find a difference in VAS score of 1.0 with a standard
deviation (SD) of 0.5 and a type 1 error of 0.05 between
groups. For the surgeon satisfaction scale the power was
82% to find a difference between groups of 0.5 with SD of
0.65 and a sample size of 61 patients and a 0.05 type 1
error.

Intraoperative complications and corneal clarity were
recorded at the end of surgery. Postoperative pain was
graded again using a 10-point visual analog scale on the


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first postoperative day approximately 24 hours later. Stu-
dent T-test was used to compare both groups. (Graph-
prizm, CA)

Results
The results of the study are summarized in Table 1. One
hundred twenty two eyes of 122 patients were operated
for cataract in the study: 61 patients were randomly
assigned to the TV group and 61 to the LG group. In TV
group there were 25 males and 36 females and in LG
group there were 28 males and 33 females. The mean age
in TV group was 70.4 4.1 (mean SD) years and in LG
group was 70.6 10.5 (mean SD) years. There was no
significant difference in age between the two groups (p =
0.89). There were no anesthesia-related complications.

Primary Outcome Measures
Intraoperative pain scores by VAS were 0.7 0.31 (mean
+ SD) in the TV group and 1.8 0.4 (mean + SD) in the
LG group. This difference was statistically significant (P <
0.001).

Secondary Outcome Measures
Patient cooperation, as graded by the surgeon, was 8.3
0.3 (mean SD) in TV group and 8.4 0.6 (mean SD)
in the LG group (p = 0.25).

Intraoperative corneal clarity was good in 59 of 61
patients (97%) in the TV group and in 55 of 61 patients
(90%) in the LG group (p = 0.16).

The mean duration of surgery was 13.1 + 2.7 minutes
overall with mean of 13.4 2.3, 12.4 3.4 and 13.7 + 2.1
minutes for the 3 surgeons who were involved in the study
(p = 0.07). Mean VAS scores for the 3 surgeons were 8.20
+ 0.5, 8.1 0.4 and 8.3 + 0.4 respectively (p = 0.12).

1 out of 61 patients (1.6%) had difficulty in IOL implan-
tation (Surgeon could not dial in the trailing haptic in a
single attempt) in TV group compared to 3 out of 61


(4.8%) patients in LG group. All other minor complica-
tions (tearing of capsulorrhexis in one patient in TV
group,) were managed uneventfully during surgery.

Discussion
TetraVisc 0.5% is a recently introduced viscous topical
anesthetic used for ocular surgery. It disperses across the
cornea rapidly and offers an extended period of anesthesia
making it superior to topical gels. Previous reported stud-
ies have shown topical tetracaine solution 0.5% with int-
racameral lidocaine to be safe and effective in cataract
surgery [10].

In our study, mean intra-operative pain as measured by
visual analog score was less in the TV group than LG
group, indicating that topical TetraVisc was superior to
lidocaine 2% gel for pain control in patients undergoing
clear corneal phacoemulsification. Amiel et al have com-
pared the anesthetic effect of the two drugs and concluded
that their effects were similar [11]. But the limitation of
their study was absence of standardization of the pain
quality using the VAS.

Specific factors evaluated during this study included
patient comfort and the surgeon's subjective impression
of patient comfort and ease of surgery. Visual analog scale
is a simple and frequently used method for assessment of
intensity of pain [ 12]. In clinical practice the percentage of
pain relief, assessed by VAS, is often considered as a meas-
ure of the efficacy of treatment and VAS score correlates
well with acute pain levels [12,13]. Myles et al have shown
that the VAS has properties consistent with a linear scale
in patients with acute mild-to-moderate pain implying
that a change in the VAS score represents a relativechange
in the magnitude of pain sensation [13]. Due to the linear
nature of the scale, studies have supported the use of par-
ametric tests for analyzing VAS scores [13,14]. Patient
comfort was superior in TV group compared to LG group
(P < 0.001). No difference was observed between the two


Table I: Patient characteristics and results of efficacy of anesthesia in the TetraVisc and Lidocaine gel group


TetraVisc group (Mean +/- SD*)


Lidocaine gel group (Mean +/- SD)


Age (in years, mean SD)

Visual analog pain scores

Patient Cooperation

Clear Corneal clarity

Intra-operative complications

* SD: Standard deviation


70.6 10.5

1.8 0.4

8.4 0.6

55/61(90%)

3/61(4.8%)


< 0.001


0.16


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P value


70.4 4.1

0.7 0.31

8.3 0.3

59/61(97%)

1/61 (1.6%)


BMC Ophthalmology 2009, 9:7








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groups in terms of surgeons' satisfaction and patient coop-
eration.

Studies have not shown any corneal endothelial toxicity
with lidocaine 2% gel both in animal and humans [15].
In our series, intra-operative corneal clarity was better in
the TV group compared to the LG group. 97% had clear
cornea in TV group as compared to 90% in LG group. Two
eyes (3%) in TV group and 6 eyes (10%) in LG group
showed mild intra-operative central corneal edema. This
could be either due to hydration, variability of operative
technique and operative time or lidocaine toxicity.

One of the limitations of the study was non-masked
design, and patients were operated by three different sur-
geons. Inter-surgeon variability in technique and duration
of surgery can influence the outcome of the study, even
though this has not been the case in our report.

Conclusion
In summary, both topical TetraVisc 0.5% and lidocaine
2% gel used independently provide good surgical anesthe-
sia and patient comfort during ocular surgery. The subjec-
tive assessment of pain by patients on an analog scale in
either group was minimal. No significant intra-operative
complications were noted in either group. TetraVisc is
superior to lidocaine 2% gel as topical anesthetic for
patient comfort while preserving corneal clarity during
surgery.

Abbreviations
LG: Lidocaine gel; TV: Tetravisc; IOL: Intraocular lens.

Competing interests
The authors declare that they have no competing interests.

Authors' contributions
KVC and SG were involved in the conception and design
of the study; SKG was involved in the acquisition of data;
SA and RK were involved in the analysis of the data and
preparation of the manuscript.

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