Original Article
Intracameral Versus Sub-conjunctival Dexamethasone Injection for
Postoperative Inflammation in Congenital Cataract Surgery
Afia Matloob Rana, Ali
Raza, Waseem Akhter
Pak J Ophthalmol 2019, Vol. 35, No. 3
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See end of article for authors affiliations …..……………………….. Correspondence to: Afia Matloob Rana Assistant Professor Ophthalmology Department HBS General Hospital,
Islamabad Email: afiamatloob@yahoo.com |
Purpose: To compare the effect
of intracameral with sub-conjunctival injection of dexamethasone in
preventing immediate postoperative inflammation after congenital cataract
extraction. Study Design: Randomized control
trial. Place and Duration of Study:
Holy Family Hospital,
Rawalpindi from June 2014 to May 2015. Material and Methods: All Pediatric
patients less than 15 years of age and of both genders, undergoing cataract
surgery in Holy Family Hospital, were included in the study using a random
table. Using standardized sample size calculator and statistical assumption
with 95% CI and 5% alpha error, the study sample was 95 cases in each group. Group
A patients got intracameral injection of dexamethasone while Group B patients
got subconjunctival injection of dexamethasone. The outcome measure was
intraocular inflammation after cataract surgery. Examination was done within
first three postoperative days for signs of anterior chamber inflammation. Standard
slit lamp or hand held slit lamp was used for this purpose. Results: One hundred and
ninety patients were included in the study. The patients were equally divided
into 2 groups. Male cases were in majority in group B (58.9%) whereas in
group A females (55.8%) were in majority. Mean age was 6.43 ± 4.69 years in Group-A compared to
5.85 ± 4.10 years in Group-B.
Frequency of posterior synechiae (inflammation) was 4.21% (n = 4) in Group-A
(intracameral) compared to 15.79% (n = 15) in Group-B (subconjunctival) which
was significantly different (p-value = 0.007). Conclusion: Intracameral
injection is better than sub-conjunctival injection of dexamethasone in the
management of post-operative inflammation in children with congenital
cataract. Keywords: Congenital cataract,
Dexamethasone, Injections, Inflammation. |
Cataract
is one of the leading causes of blindness worldwide. It accounts for nearly
half (47.8%) of the total 17.7 million cases of blindness1. Pakistani
population is also getting equally affected from cataract, with high prevalence2.
The
partial or complete blindness is mainly affecting the elder population and
reducing their quality of life by making them dependent on others and posing
economic burden on communities and the country2,3. Nevertheless, cataract
affects all age groups but comparatively it is less common in children. VISION
2020 the ‘Right to Sight’ is the main initiative program to control the visual deterioration
and ultimate lasting blindness among children of developing countries.3
Lifelong impact of cataract in childhood is very large considering the
potential lifespan of a child4.
Congenital Cataract is cloudiness of the
crystalline lens of the eye, which is present at birth and is mostly bilateral,
clinically present with decreased vision or white reflex. It is diagnosed on
slit-lamp bio-microscopy of the anterior segment of the eye. It can present in
any form like nuclear, lamellar, sutural, coronary, polar and membranous
cataract. The most common presentation is the nuclear cataract5.
The
treatment for visually significant cataract is surgical, a highly cost
effective intervention, with excellent prognosis for sight restoration. Early
management of congenital cataract prevents the child from developing amblyopia
and ensures good visual outcome6.
Congenital
cataract surgery can result in complications like posterior capsule opacification,
glaucoma and retinal detachment7. Most common post operative complication
in congenital cataract is inflammation8. Inflammation can
lead to complications like peripheral anterior synechiae, posterior synechiae,
exudative membrane and pupil block glaucoma, thus hampering good visual
rehabilitation. The rationale of the study was to find a treatment option which
would reduce the post-operative inflammation and prevent complications.
Intensive
conventional topical steroid treatment is still main trusted mode of managing
inflammation, along with other available options, like sub-conjunctival
injection during surgery, collagen shield, intracameral injection and sustained
release intraocular drug delivery system9,10.
There are various therapeutic options for inflammation with
different levels of efficacy and safety. We planned a study with the purpose of
comparing the role of intracameral injection with sub-conjunctival injection of
dexamethasone in preventing immediate postoperative inflammation after congenital
cataract extraction.
MATERIAL
AND METHODS
A
randomized controlled trial was conducted at the department of ophthalmology,
Holy Family Hospital, Rawalpindi for a period of one year from June 2014 to May
2015. Using standardized sample size calculator and statistical assumption with
95% CI and 5% alpha error, the study sample was 95 cases in each group. It was hypothesized that Intracameral injection
of 0.5 ml (2 mg) dexamethasone reduces immediate postoperative inflammation
after surgery for congenital cataracts. A total of 190 children with cataract were
enrolled (WHO calculator), using a random table, 95 cases each in intra-cameral
injection and sub-conjunctival injection groups.
Children
less than 15 years and of both genders were enrolled. Visually significant
congenital cataract was determined by Snellen’s visual acuity of < 6/6 for
verbal child and cataract size more than 3 mm in the area of visual axis,
obscuring fundal glow for non-verbal child. Cases with no associated anterior
or posterior segment pathology were selected. Patients with secondary cataract,
prior ocular surgery and per operative complication e.g. posterior capsular
rent, nucleus drop were excluded from the study.
All
the children were operated for aspiration of the lens, primary posterior surgical
capsulotomy and anterior vitrectomy. Children below age of two years were
operated without intraocular lens implantation while above two years with
intraocular lens implantation. In group A, patients were given intra-cameral
dexamethasone injection 0.5 ml (2 mg) and 0.5 ml (20 mg) gentamycin injection in
sub-conjunctival area. In group B, 0.5 ml (2 mg) dexamethasone and 0.5 ml (20 mg)
gentamycin injection were given in the sub-conjunctival space at the end of
surgery.
Examination
was done within first three postoperative days, for signs of immediate anterior
chamber inflammation, by standard slit lamp or hand held slit lamp. In case of non-cooperative
children, examination was done with hand held slit lamp under sedation or
general anesthesia for posterior synechiae. Postoperatively all patients were given
topical dexamethasone suspension (1 drop after every 1 hour), tobramycin eye
drops (one drop after every 2 hours), 1% cyclopentolate eye drops (one drop
after every 8 hours) for one week.
The
study outcome was measured in terms of efficacy of intracameral injection and
subconjunctival injection of dexamethasone in the treatment of inflammation
after surgery of congenital cataract.
The data was entered and analyzed in SPSS version 20.0. Continuous
variable like age was presented as Mean and SD. The categorical variables like
gender, inflammation (posterior synechiae) was analyzed as frequency and
percentages and compared between the two groups using chi-square test, a p-value
of < 0.05 was taken as significant.
RESULTS
One
hundred and ninety cases (95 in each group) fulfilling the inclusion/exclusion
criteria were enrolled to intracameral injection or sub-conjunctival injection
of dexamethasone to see their effect on postoperative inflammation in
congenital cataracts.
Age
distribution of the cases showed that majority of the cases were within 1-10
years of age. In group A there were 73.68% (n = 70) patients and in Group-B there
were 78.95% (n = 75). The results of age
distribution are shown in Table 1.
The
gender distribution showed that there was nearly equal distribution among males
and females. The results of gender distribution are shown in Figure 1.
Comparison of the Intracameral injection with sub-conjunctival injection
of Dexamethasone in terms of frequency of posterior synechiae (inflammation) was
recorded which showed that 4.21% (n = 4) in Group-A and 15.79% (n = 15) in
Group-B had posterior synechiae while remaining 95.79% (n = 91) in Group-A and
84.21% (n = 80) in Group-B had no findings of the morbidity. This difference in
the incidence of inflammation post operatively was found statistically significant
between the two groups (p-value, 0.007) (Table 2).
Table 1: Age Distribution (n = 190).
|
Age (in Years) |
Intracameral Injection
Group (A) (n = 95) |
Subconjunctival
Injection Group (B) (n = 95) |
||
|
No. of patients |
% |
No. of patients |
% |
|
|
1 – 10 |
70 |
73.68 |
75 |
78.95 |
|
11 – 15 |
25 |
26.32 |
20 |
21.05 |
|
Mean ± SD |
6.43 ± 4.69 |
5.86 ± 4.10 |
||
Table 2: Comparison of
Posterior Synechiae between the Two Study Groups (n = 190).
|
Inflammation (Posterior Synechiae) |
Intracameral Injection
Group (A) (n = 95) |
Subconjunctival
Injection Group (B) (n = 95) |
p-value |
||
|
No. of patients |
% |
No. of patients |
% |
||
|
Yes |
4 |
4.21 |
15 |
15.79 |
0.007 |
|
No |
91 |
95.79 |
80 |
84.21 |
|
Fig. 1: Gender distribution in both study groups (n = 190).
DISCUSSION
Congenital cataract is an important reason of visual
impairment among children, throughout the world and 5%-20% of blindness in
children is because of congenital cataract11,12. All over the world 1.4
million children are blind and blindness in 190,000 children is because of
cataract13. Congenital cataract presents either since birth or
shortly after birth14,15. In Asia 1 million children are blind
because of congenital cataracts16. The estimated prevalence of
cataract among children is 3 in 10,000 live biths17.
Surgical
option is the main management strategy in these conditions, which is successful,
however, some side effects also worries the patients. Ocular inflammation is
one such complaint. The peri-operative use of anti-inflammatory therapy has
well established role in standard cataract surgery. The aim is to treat
postoperative intraocular inflammation and enhance patient's comfort. Different
anti-inflammatory agents are used according to the patient's need and surgeon’s
preferences18.
In
the present study posterior synechiae were recorded in 4.21% cases in Group-A
and 15.79% in Group-B, and the difference was statistically significant (p-value,
0.007). Our findings regarding significantly greater success of intracameral
dexamethasone are in accordance with many previous studies. A study by Iqbal
and colleagues reported that dexamethasone when injected
intracamerally increased its efficacy by about 5% as compared to
subconjunctival route19. Ahmad et al who evaluated the role of subconjunctival and intracameral
dexamethasone found that the later had better results and concluded that intracameral
injection of dexamethasone was superior to sub-conjuctival injection of
dexamethasone in preventing immediate postoperative anterior uveitis20.
Another recent study evaluated the effect of intracameral dexamethasone on
corneal endothelium, and concluded that the use of intracameral dexamethasone
at the end of cataract surgery is safe for corneal endothelium21. The
study by Zhang et al demonstrated that the average
inflammation score was significantly lower in Dexamethasone group compared with
the Indomethacin and Ciprofloxacin groups. Moreover, they also witnessed
decreased intra‑ocular pressure with Dexamethasone compared to other
study interventions22.
Our
findings are in agreement with the above body of evidence, which is justifying
the hypothesis that “Intracameral injection of 0.5 ml (2 mg) dexamethasone
reduces immediate postoperative inflammation after surgery for congenital
cataracts”, Intracameral injection may be used for better management of postoperative
inflammation following congenital cataract extraction.
Limitation of the study was that it was a single center study,
which was focused on early post-operative results. Further study needs to be
done to evaluate long term results of this intervention at multiple centers.
CONCLUSION
Intracameral injection of dexamethasone is significantly better than
subconjunctival injection in terms of frequency of early postoperative
inflammation in congenital cataracts. This leads to better visual
rehabilitation.
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Author’s Affiliation
Dr. Afia Matloob Rana
MBBS, FCPS
Assistant Professor; Ophthalmology
HBS general Hospital, Islamabad. Pakistan
Dr. Ali Raza
MBBS; MCPS; FCPS
Professor; Ophthalmology
Holy Family Hospital. Rawalpindi Pakistan
Dr. Waseem Akhter
MBBS; MCPS; FCPS
Associate Professor; Ophthalmology
Rawal Institute of Health Sciences, Islamabad
Author’s Contribution
Dr. Afia Matloob Rana
Data collection, Preoperative and postoperative patient
evaluation, Assistance during surgeries of patients, included in the study
Dr. Ali Raza
Surgeon performed the surgeries upon the study cases, Helped in
preoperative and post-operative evaluation to the primary author
Dr. Waseem Akhter
Final compilation of data, Preparation of SPSS data sheets, Data
analysis, Paper writing