Original Article
Comparison of Anti-inflammatory Effect
between Intracameral Triamcinolone Acetonide and Topical Dexamethasone after
Phacoemulsification
Asif
Manzoor, Muhammad Moin
Pak J Ophthalmol 2018, Vol. 34, No.
1
. . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
See end of article for authors affiliations
..
.. Correspondence to: Asif
Manzoor VR
Fellow Department of Ophthalmology, Lahore General Hospital, Lahore. Email:
asifmanzoor259@gmail.com |
Purpose: To
compare the role of single dose intracameral injection of triamcinolone
acetonide versus topical dexamethasone to control post-operative inflammation
after phacoemulsification. Study Design: Randomized controlled trial. Place and Duration of Study: Ophthalmology Department, Lahore General Hospital, Lahore, from
March 2015 to August 2015. Material and Methods: A total of 60 patients of 40 70 years of age of either gender
undergoing phacoemulsification for cataract were included. Selected patients
were placed randomly into two groups by using lottery method. Group A
patients were given 1 mg/0.1 ml triamcinolone acetonide into anterior chamber
at the end of surgery and no topical steroids were given post-operatively.
Group B were not given intracameral injection but topical dexamethasone eye
drops were given 4 hourly for one week and then four times a day for 4 weeks.
Outcome variable was control of post-operative inflammation, which was noted
at day 1, 7 and 28. Results: Mean age of patients in group A was 58.63 ± 7.30 years and in group B
was 56.63 ± 5.87 years. Out of 60
patients, 34 (56.67%) were males and 26 (43.33%) were females. The male to
female ratio was 1.3:1. The difference in efficacy between the two groups was
statistically non-significant. Conclusion: Single dose Intracameral
injection of triamcinolone acetonide controls post-operative
inflammation after phacoemulsification without the use of any eye drops and
is equally as effective as topical dexamethasone for post-operative inflammation Keywords:
Cataract, inflammation, Phacoemulsification, Triamcinolone. |
Cataract is the leading cause of treatable blindness
in the world1. In Pakistan, 51.5% blindness is due to cataract2.
Amongst all people with visual impairment due to cataract in the world, about
65% are above 50 years of age3. More than 50% of people over the age
of 65 develop age-related cataract with significant decrease in vision4.
Globally, with increase in population, age and lifespan of people, cataract
cases are expected to increase in number. Cataract is the leading cause of
vision loss in developed and developing countries5.
Cataract surgery is the most commonly
performed procedure done by ophthalmologists worldwide6.
Approximately 18 million cataract surgeries are performed every year in the
world and expected to increase as the population and lifespan increases7.
Small-incision cataract surgery using Phacoemulsification has become the most
popular modern technique and gold standard in cataract surgery8. Inspite
of improved surgical techniques and intraocular lenses postoperative inflammation
is one of the most common postoperative complications. Blood aqueous barrier is
damaged due to surgical trauma which causes leakage of proteins and
inflammatory cells into the anterior chamber. Uncontrolled postoperative
inflammation can increase recovery time, increased intraocular pressure (IOP),
synechiae formation and cystoid macular edema9, 10.
Routinely topical steroids are used in
treatment of postoperative inflammation after cataract surgery. Other routes of
delivery of steroids in eye include intracameral, sub-tenon, sub-conjunctival
and intravitreal injections11. A study by Coronel MCG
et al12 showed that intracameral triamcinolone use is safe and
post-operative inflammation was resolved in 100% cases after four weeks of
phacoemulsification. A study held in Pakistan by Waseem M13 showed
that topical dexamethasone 0.1% resolved post-operative inflammation in 98%
cases after five weeks of phacoemulsification. No study has been published in
Pakistan on use of intracameral triamcinolone after phacoemulsification.
Topical steroids are
effective in controlling post-operative inflammation but they have few
disadvantages like poor compliance due to multiple time dosage daily, tear film
disruption and irritation. The purpose of this study was to see the comparison between efficacy of single
dose intracameral triamcinolone injection and topical dexamethasone in
controlling post-operative inflammation after phacoemulsification in our
population. On the basis of these results, some practical recommendations can
be made in our routine practice for reducing
post-operative inflammation after phacoemulsification in order to reduce
the morbidity and improving patient compliance.
METHODOLOGY
Study was conducted in Ophthalmology
department, Lahore General Hospital, Lahore, from March 2015 to August 2015.
Study design was Randomized controlled trial and Non-probability, consecutive
sampling technique was used.
After
approval from the ethical review committee a total of 60 patients between 40 - 70 years age of either gender were admitted to Ophthalmology Unit-II, Lahore General Hospital, Lahore
to undergo phacoemulsification for cataract. Patients with anterior uveitis, any ocular pathology, any
complication during cataract surgery like posterior capsular rupture and
vitreous loss, previous surgery and
co-morbid conditions were excluded. All patients were operated by the
same consultant ophthalmologist (at least 10 years of experience) by
phacoemulsification procedure with foldable intraocular lens implantation under
topical anaesthesia.
After taking written, informed consent for
participation in the study, a total of 60 cases were selected and were divided
in two groups by lottery method.Group A comprising of 30 patients were
given single intracameral injection of triamcinolone acetonide 1mg at the end
of surgery using a 27-guage cannula. Post-operatively Moxifloxacin 0.5% eye
drops (one drop every six hours) given for 4 weeks. Group B comprising of 30 patients were not given intracameral
triamcinolone acetonide injection. Post-operatively Dexamethasone 0.1% eye
drops (one drop every four hours) and Moxifloxacin 0.5% eye drops (one drop
every six hours) were given for 4 weeks with gradual tapering of dose of
dexamethasone eye drops. All patients in both groups were evaluated by same
consultant at 1st, 7thand 28thday after surgery
for anterior chamber inflammation (Cells and Flare). Anterior chamber cells were
examined in 1x1mm slit beam field and grading was done as: Grade 0 = <5
cells, Grade 1 = 6 - 15 cells, Grade 2 = 16 - 25, Grade 3 = 26 - 50, Grade 4 =
> 50. Grading of Aqueous flare was done as following: 0 = none; 1
= mild (just detectable); 2 = moderate (iris details clear); 3 = marked
(iris details hazy), and 4 = severe (heavy with fibrin deposits and
clots).
All the data was
recorded on a predesigned proforma. The data was entered and analyzed by SPSS
version 20.Comparison between the groups with respect to efficacy was analyzed
by chi square. P value ≤ 0.05 was considered significant.
RESULTS
Range of Age of patients in this study was from 40 - 70 years with
mean age of 57.35 ± 6.57 years.
Mean age of patients in group A was 58.63 ± 7.30 years and in group B was 56.63 ± 5.87 years. Majority of the patients 37 (61.67%) were between
56 to 70 years of age as shown in Table 1. Among 60 patients, 34
(56.67%) were males and 26 (43.33%) were females and male to female ratio was
1.3:1 as shown in figure 1.
Fig. 1: %age of Patients According to
Gender.
Table 2 shows the mean post-operative
inflammation (anterior chamber cells and flare) at day 1 and day 7 in both
treatment groups. Flare was resolved in majority of the cases at day 7 and at
28th day post-operative inflammation (cells and flare) was
completely resolved in both groups. Both drugs were equally effective in
controlling post-operative inflammation with a p-value > 0.05 that was statistically
non-significant.
Intraocular pressure was
monitored in all patients pre-operatively and all post-operative visits. Pre-operative
mean IOP in group A and B was 15.67 and 15.83 mmHg respectively. Post-operative
mean IOP in group A and B was 16.33 and 16.17 mmHg at post-op day 1 and 14.83
and 14.93 mmHg at post-op day 28.The change in IOP was not significant in both
groups as shown in Table 3. There was no case of post-operative endophthalmitis
or secondary glaucoma in both groups.
Table 1: Age distribution for both
groups (n = 60).
Age (Years) |
Group A (n = 30) |
Group B (n = 30) |
Total (n = 60) |
|||
No.
of patients |
%age |
No.
of patients |
%age |
No.
of patients |
%age |
|
40 - 55 |
11 |
36.67 |
12 |
40.0 |
23 |
38.33 |
56 - 70 |
19 |
63.33 |
18 |
60.0 |
37 |
61.67 |
Mean ± SD |
58.63 ± 7.30 |
56.63 ± 5.87 |
57.35 ± 6.57 |
|||
0.12 |
Ψ
P-value is >0.05 which is
statistically non-significant.
Table 2: Efficacy of both Groups.
|
Group
A (n = 30) |
Group
B (n = 30) |
p-value |
|||
Mean |
Range |
Mean |
Range |
|||
Cells |
Day 1 |
1.7 |
0 - 2 |
1.8 |
0 - 2 |
0.41 |
Day 7 |
0.2 |
0 - 1 |
0.23 |
0 - 1 |
0.14 |
|
Day 28 |
0.0 |
0 - 0 |
0.0 |
0 - 0 |
1.0 |
|
Flare |
Day 1 |
0.23 |
0 - 1 |
0.27 |
0 - 1 |
0.42 |
Day 7 |
0.07 |
0 - 1 |
0.10 |
0 - 1 |
0.64 |
|
Day 28 |
0.0 |
0 - 0 |
0.0 |
0 - 0 |
1.0 |
Ψ
P-value is > 0.05 which is
statistically non-significant.
Table 3: Mean Intraocular Pressure of
both Groups.
|
Group
A (n=30) |
Group
B (n=30) |
p-value |
|
Mean |
Mean |
|||
Intra-Ocular Pressure (IOP) (mmHg) |
Pre-Op |
15.67 |
15.83 |
0.98 |
Day 1 |
16.33 |
16.17 |
0.61 |
|
Day 7 |
15.36 |
15.40 |
0.18 |
|
Day 28 |
14.83 |
14.93 |
0.26 |
Ψ
P value is > 0.05 which is
statistically not significant.
DISCUSSION
Management of inflammation is thus a main
focus in modern era cataract surgery14. Steroids have strong
anti-inflammatory effect that act on a number of intercellular inflammatory
mediators. Corticosteroids are being used by ophthalmologists since 1950s to
reduce post-operative intraocular inflammation by controlling inflammatory cell
leakage and inhibiting proliferation of fibroblasts and formation of
granulation tissue15. There are different methods to use
corticosteroids in eye like topical eye drops, subconjunctival, subtenon and
retrobulbar injections or systemic steroid in the form of oral medication,
intramuscular or intravenous injections. So, we have conducted this study to
compare the efficacy of single dose intracameral injection of triamcinolone
acetonide versus topical dexamethasone in preventing post-operative
inflammation after phacoemulsification in patients with cataract.
Triamcinolone acetonide is
being used to treat posterior segment inflammatory diseases in the form of
intraocular injections. Oh et
al16 injected
triamcinolone acetonide into anterior chamber of rabbit eyes to check its
effect on corneal endothelium. They examined after 2 hours of injection and
found there was decrease in microvilli but no statiscally significant
difference noted on endothelial cell count and central corneal thickness. Chang
et al18
also found some toxic effects of triamcinolone
acetonide on cultured endothelium. Despite toxic effects of triamcinolone
acetonide on corneal endothelium shown by some studies, triamcinolone acetonide
is being used to control postoperative inflammation after cataract surgery.
Gills and Gills18 injected
different doses of triamcinolone acetonide in anterior chamber to control post
cataract surgery inflammation. They started with 0.25 mg and gradually
increased to 3.0 mg and 4.0 mg in patients with diabetes mellitus but they
could not find appropriate dose. They suggested that increasing the dose of
triamcinolone acetonide decreased the requirement of postoperative steroid use
from 45% to 2% with 1.8 - 2.1 mg dose.
In a prospective study19 60 patients were randomized into
two groups. Half of the patients had to receive single intracameral injections
of triamcinolone acetonide and gentamicin at the end of phacoemulsification and
then followed by topical tobramycin eye drops four times daily for one week (IC
TA group, n = 30). Other half of patients had to use topical
dexamethasone-tobramycin combination eye drops after phacoemulsification for
four times daily until no inflammation was seen (Topical group,
n = 30). They found no significant difference between the two groups in
anterior chamber cells at one day and one week after surgery (p = 0.50 and
0.328, respectively). However they observed that the anterior chamber cells
were significantly less in the IC TA group than in the Topical group at one
month postoperatively (p = 0.006). No significant difference was seen between
two groups in terms of mean BCVA or IOP at any time point (p > 0.05). No
significant complications like endophthalmitis were observed.
Intracameral and intravitreal triamcinolone
injected after performing phacoemulsification, in combination with standard
postoperative corticosteroid eye drops, has beneficial role in uveitic eyes20-21.
Gills JP et al18 successfully replaced postoperative steroid drops
use with higher concentrations of intracameral steroid injection after cataract
surgery. Chang
DTW et al17 in a study used intracameral dexamethasone at the end of
cataract surgery and found that it significantly decreases postoperative
inflammation in eyes with and without glaucoma.
Postoperative inflammation after cataract
surgery is treated with topical corticosteroids and they prove to be effective
but they have some side effects like poor compliance due to frequent use of eye
drops after cataract surgery, toxic effects of topical drops and preservatives
on cornea, irritation in eyes due to tear film disruption, and substantial cost
of topical drops. To minimized these side effects of topical eye drops
alternate routes of corticosteroids use are under trials.22
Karalezli A et al23 reported
effective suppression of post-operative inflammation with intracameral
triamcinolone acetonide injection after cataract surgery. He concluded that
intracameral steroids and topical prednisolone are equally effective in
controlling post cataract surgery inflammation. Intracameral steroids improve
patient compliance and help to avoid side effects of topical eye drops like
corneal melting, dry eyes and conjunctival irritation.
Intracameral injection
of triamcinolone can have advantage in complicated cases when chances of
postoperative inflammation are higher. Intracameral injection of triamcinolone
can reduce cystoid macular edema after posterior-capsular rupture and chances
of macular edema in diabetic patients by gaining access to posterior segment
through zonules. So, on the whole it is concluded that intracameral
triamcinolone injection is an effective way to reduce post-operative
inflammation after phacoemulsification. It may be an alternate option to the
topical dexamethasone and should be used routinely in our general practice.
CONCLUSION
This study concluded
that single dose Intracameral injection of triamcinolone acetonide and post-operative topical
dexamethasone are equally effective in controlling post-operative inflammation
after phacoemulsification. So, we recommend that Intracameral injection of triamcinolone acetonide can be used routinely
per-operatively in these particular patients instead of topical dexamethasone in order to prevent multiple and frequent use of eye
drops that are usually prescribed after phacoemulsification.
Authors Affiliation
Dr. Asif Manzoor (FCPS Ophthalmology)
Ophthalmology Department. Lahore General Hospital, Lahore.
House # 570. G- Block. Gulshan-e-Ravi, Lahore.
Dr. Muhammad Moin (Professor of Ophthalmology)
Ophthalmology Department. Lahore General Hospital, Lahore.
Role of Authors
Dr. Asif Manzoor
Data Collection, Manuscript Writing, Data Analysis
Dr. Muhammad Moin
Manuscript Review, Study Design
REFERENCES
1.
Murthy GVS, John N, Shamanna BR, Pant HB. Elimination of avoidable blindness due to cataract: Where do we
prioritize and how should we monitor this decade? Ind J Ophhthalmol. 2012; 60:
438-445.
2.
Jamil AZ, Ahmed A, Mirza KA. Effect of intracameral use of Dexamethasone on corneal endothelial
cells. Coll Phys Surg Pak. 2014; 24: 245-248.
3.
Fact
sheet N 282. Updated October 2013. Visual impairment and blindness. World
Health Organization.
4.
Dua HS, Attre R. Treatment of Post-operative Inflammation
following Cataract Surgery - a review. Eur Ophthalmol Rev. 2012; 6: 98-103.
5.
Khairallah M, Kahloun R, Bourne R, et al. Number of people blind or
visually impaired by cataract worldwide and in world regions, 1990 to 2010.
Invest Ophthalmol Vis Sci. 2015 Oct; 56 (11): 6762-9.
6.
Hashmi FK, Khan QA, Chaudhry TA, Ahmad K. Visual outcome of cataract surgery. Coll Phys Surg Pak. 2013; 23:
448-449.
7.
Pascolini D, Mariotti SP. Global
estimates of visual impairment: 2010. Br J Ophthalmol, 2012; 96 (5): 614618.
8.
Zusman NB. The
Miracle of Modern Cataract Surgery: No Needle, No Stitch, No Patch. July 28,
2013; Feeling fit, SUN Newspapers.
9.
Imdad T, Tanweer FS, Raza A. Effect of Dexamethasone versusDiclofenac Sodium after
phacoemulsification with intraocular lens implantation. JRMC; 2013; 17: 254-256.
10.
Amon M, Busin M. Loteprednoletabonate
ophthalmic suspension 0.5%: efficacy and safety for postoperative
anti-inflammatory use. Intophthalmol. 2012; 32: 507-517.
11.
Patel A, Cholkar K, Agrahari V, Mitra AK. Ocular drug delivery systems: An overview. World J Pharmacol. 2013; 2 (2): 4764.
12.
Coronel M. C. G, Co GN. Safety and efficacy of intracameral triamcinolone in post
cataract inflammation. Philippine J Ophthalmol. Jan Jun 2008.
13.
Waseem M, Humayun S.
Comparison of anti-inflammatory activity of dexamethasone and diclofenac sodium
eye drops in phacoemulsification. J Coll Physic Surge Pak. 2009; 19: 570-574.
14. Chen P, Han X, Zhu Y, Xu J. Comparison of
anti-inflammatory effects of flourometholone 0.1% combined with levofloxacin
0.5% and tobramycin/dexamethasone eye drops after cataract surgery. Int J Ophthalmol. 2016; 9 (11): 16191623.
15.
Ellis PP.
Pharmacological effects of corticosteroids. Int Ophthalmol Clin. 1996; 6: 799819.
16. Oh JY, Wee WR, Lee JH, Kim MK. Short-term effect of
intracameral triamcinolone acetonide on corneal endothelium using the rabbit
model. Eye
(Lond) 2007; 21: 8128.
17. Chang YS, Tseng SY, Teseng SH, Wu CL, Chen MF. Triamcinolone acetonide
suspension toxicity to corneal endothelial cells. J Cataract Refract Surg.
2006;
32: 154955.
18. Gills JP, Gills P. Effect of intracameral triamcinolone to control inflammation
following cataract surgery. J Cataract Refract Surg. 2005; 31: 16701.
19.
Simaroj
P1, Sinsawad
P, Lekhanont
K. Effects of intracameral triamcinolone and gentamicin injections following
cataract surgery. J
Med Assoc Thai. 2011 Jul; 94: 819-25.
20. Li J, Heinz C, Zurek-Imhoff B, Heiligenhaus A. Intraoperative
intraocular triamcinolone injection prophylaxis for post-cataract surgery
fibrin formation in uveitis associated with juvenile idiopathic arthritis. J Cataract Refract Surg.
2006;
32: 153539.
21. Dada T, Dhawan M, Garg S, Nair S. Safety and efficacy of
intraoperative intravitreal injection of triamcinolone acetonide injection
after phacoemulsification in cases of uveitic cataract. J Cataract Refract Surg.
2007;
33: 161318.
22.
Sanders DR, Kraff M.
Steroidal and non-steroidal anti-inflammatory agents: effects on post-surgical
inflammation and blood) aqueous humour barrier breakdown. Arch Ophthalmol.
1984; 102: 14546.
23.
Karalezli A, Borazan M, Akova YA. Intracameral triamcinolone acetonide to control postoperative inflammation
following cataract surgery with Phacoemulsification. Acta Ophthalmol. 2008; 86:
1837.