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 Table of Contents    
ORIGINAL ARTICLE
Year : 2019  |  Volume : 12  |  Issue : 1  |  Page : 25-30  

Comparison of a single intraoperative posterior sub-Tenon's capsule triamcinolone acetonide injection versus topical steroids for treatment of postcataract surgery inflammation in children


1 Department of Ophthalmology, Christian Medical College and Hospital, Vellore, Tamil Nadu, India
2 Department of Biostatistics, Christian Medical College and Hospital, Vellore, Tamil Nadu, India

Date of Web Publication30-Jan-2019

Correspondence Address:
Dr. Swetha Sara Philip
Department of Ophthalmology, Christian Medical College, Vellore - 632 001, Tamil Nadu
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ojo.OJO_147_2017

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   Abstract 


BACKGROUND: The aim of this study is to compare the clinical efficacy of a single intraoperative posterior sub-Tenon's capsule triamcinolone acetonide injection with postoperative topical steroids in controlling intraocular inflammation in uncomplicated pediatric cataract surgery.
MATERIALS AND METHODS: A prospective comparative study of children (<13 years of age) undergoing cataract surgery in a tertiary care eye center in South India. Preoperative evaluation was similar in both groups. The surgical procedure was the same for both groups except at the end of surgery only Group 1 (right eye of bilateral cataracts and all unilateral cataracts) received intraoperative 0.5 ml (40 mg/ml) posterior sub-Tenon's injection of triamcinolone acetonide. Postoperatively, Group 1 was administered only topical antibiotic and Group 2 was put on topical antibiotic, mydriatic, and steroids. Intraocular inflammation and intraocular pressure (IOP) were assessed clinically on day 1, 1st week, 1st month, and 3 months, postoperatively.
RESULTS: A total of 30 eyes were included in the study. Age ranged between 1 month and 132 months, with 18 eyes included in Group 1 and 12 eyes in Group 2. The mean postoperative IOP at the 3 months follow-up was not significantly different between groups (P = 0.4). The presence of intraocular lens had no role in postoperative inflammation (P = 1). Group 2 showed more anterior segment inflammation with six eyes (50%) developing posterior synechiae and distortion of the pupil 3 months postoperatively.
CONCLUSION: In pediatric cataracts, a single intraoperative sub-Tenon's capsule injection of triamcinolone acetonide appears to be safe and effective in controlling postcataract surgery inflammation.

Keywords: Cataract surgery, inflammation and intraocular pressure, pediatric, subtenon's injection, triamcinolone


How to cite this article:
Philip SS, Braganza AD, Rebekah GJ. Comparison of a single intraoperative posterior sub-Tenon's capsule triamcinolone acetonide injection versus topical steroids for treatment of postcataract surgery inflammation in children. Oman J Ophthalmol 2019;12:25-30

How to cite this URL:
Philip SS, Braganza AD, Rebekah GJ. Comparison of a single intraoperative posterior sub-Tenon's capsule triamcinolone acetonide injection versus topical steroids for treatment of postcataract surgery inflammation in children. Oman J Ophthalmol [serial online] 2019 [cited 2019 Mar 21];12:25-30. Available from: http://www.ojoonline.org/text.asp?2019/12/1/25/251028




   Introduction Top


Congenital and developmental cataract is one of the major causes of avoidable blindness in children both in the developing countries and developed world.[1] Although idiopathic bilateral congenital cataract is a more common presentation, unilateral idiopathic cataract is seen in 8%–52% of cases.[2],[3] Early diagnosis and surgery followed by appropriate refractive error correction are important for better visual outcome[4],[5] but often early surgical intervention is associated with clinically significant inflammatory reactions and secondary glaucoma.[6],[7] Systemic and intensive topical steroid treatment though shown to provide good postoperative control of inflammation[8],[9],[10] are often accompanied by an ocular hypertensive response and potential systemic adverse effect which is dose and age-dependent.[10],[11] Studies report poor compliance to such an intense postoperative regimen, resulting in subtherapeutic doses of the drug in the eye and complications that can adversely affect the visual prognosis.[12] To overcome these problems, newer steroid preparations and drug delivery systems are being tried out.[13]

Triamcinolone acetonide has been used extensively in ophthalmology as a vitreous dye in vitreoretinal surgeries, to control inflammation in uveitis and also to modulate postoperative inflammation in cataract surgeries both in adults and children.[12],[13],[14],[15],[16] The advantage of using this drug intraoperatively is that it is easy to administer and has a prolonged effect in the eye without losing its efficacy.[16],[17] However, triamcinolone acetonide has adverse effects such as steroid-induced glaucoma, retinal pigment epithelial toxicity, and corneal endothelial decompensation.[18],[19],[20] Sub-Tenon's injection of triamcinolone acetonide (STA) is a well-documented route of drug delivery for various ocular conditions.[13] In a recent study reported in adult cataract surgery, STA was reported to be a safe and effective alternative to postoperative eye drops to control postoperative inflammation.[21]

In our clinical experience, we found that low socio-economic background and poor compliance to frequent medications were the main hindrance to successful surgical outcomes in children. We planned this study with the aim of finding an alternative treatment to frequent doses of topical medication, which would be safe, cost-effective to the patient as well as provide good postoperative control of inflammation. To the best of our knowledge, this is the first reported use of STA in uncomplicated pediatric cataract surgery as a primary modality of treatment in controlling postoperative inflammation.


   Materials and Methods Top


This was a prospective comparative study, in children (<13 years of age) with visually significant congenital or developmental cataract. The intent was to collect as much data as possible; so as to provide us with sufficient cause to initiate a long-term formal randomized study. This study was carried out at a tertiary care eye center in South India from September 2015 to July 2016. The study protocol had the approval of the Institutional Review and Ethics Board.

Study protocol

Children (<13 years of age) with unilateral or bilateral congenital or developmental cataract compromising the red reflex or visual difficulty in carrying out age-appropriate activities of daily living including school work were eligible for the study. The morphology of the cataract included in the study was zonular, nuclear, or total. Exclusion criteria included children with associated systemic condition, traumatic cataract, previously diagnosed glaucoma, congenital rubella syndrome, tumors, and congenital anomalies such as microphthalmia, posterior persistent fetal vasculature, aniridia, hazy cornea, and retinal detachment. Informed written consent was obtained from the patient's parents for the study. In accordance with the preferred practice pattern in our institution, we performed primary posterior capsulotomy with partial anterior vitrectomy (PPC + PAV) in children ≤5 years of age and in older children who were not cooperative for a preoperative slit-lamp (including intraocular pressure [IOP] check) and dilated fundus examination. The latter decision was based on the practical difficulty of examination under anesthesia and Nd-YAG laser under general anesthesia in this group of patients. In case of bilateral cataract, the eye with more significant cataract was operated first followed by surgery for the second eye within 1 week. Children <24 months of age were left aphakic and children ≥24 months of age had an intraocular lens (IOL) implanted aiming at a predicted postoperative retinoscopy of + 1.0D. The rise in IOP was defined as IOP >24 mmHg at any of the postoperative visits. In case of rise in IOP, it was planned to first manage medically and if found to be refractory to medical treatment, to proceed to surgical management including excision of the STA depot and glaucoma filtering surgery. Clinical assessment of IOP and anterior segment inflammation (cells, flare, pigment deposits on the IOL, posterior synechiae, and exudative membrane) using the Standardized Uveitis Nomenclature classification[22] was done on day 1, week 1, 1st month, and 3rd month postoperatively.

For this study, the eyes were assigned to two groups:

Group 1: (study group) comprised the right eye of children with bilateral cataract and the involved eye in unilateral cataract.

Group 2: (control group) comprised the left eye of children with bilateral cataract.

Preoperative examination

Both groups had similar preoperative evaluation. Ophthalmology examination included a detailed birth, family, and ocular history from the parents, preoperative fixation pattern, pupillary reaction, and distant direct ophthalmoscopy. Best-corrected visual acuity wherever possible was recorded. Slit-lamp examination included anterior segment examination, IOP measurement using Goldmann applanation tonometer (GAT), and documentation of the morphology of the cataract with a dilated pupil. In very young patients, IOP was measured using a tono-pen (Medtronic Solan, TONO-PEN ® XL CE0123) with patient in the supine position under sedation using syrup trichloryl (0.75 ml/Kg body weight). Even though tono-pen has been reported to be less accurate than GAT in children in supine position,[23] we found it technically easy to use in sedated children comfortably positioned on their parent's lap. An average of 3 recordings was taken as the IOP value. Dilated pupil indirect ophthalmoscopy was performed. In eyes with dense cataract, which precluded fundus examination, an ultrasound B-scan was done to rule out any posterior segment pathology. IOL calculation was done using axial length measurement (A-Scan-Tomey AL-4000, Bio + Pachymeter) and keratometry (Nidek KM-500 autokeratometer). The SRK-T formula was used for choosing the appropriate IOL for implantation.

Operative steps

A single surgeon (SP) performed the surgery in all 30 eyes under general anesthesia. The lens matter was removed through an anterior approach using bimanual irrigation and aspiration following hydrodissection and cortical cleaving. PPC (3.5–4 mm) and PAV with IOL implantation was performed according to the study protocol. A 3-piece hydrophobic acrylic IOL (Sensar Optiedge, Abbott Medical Optics, Santa Ana, California) was implanted in the bag. The operative time was 25–30 min.

Group 1 (study group): About 5 mm from the limbus, in the inferotemporal quadrant, the conjunctiva and Tenon's were incised to enter the sub-Tenon's space. A 0.5 ml (40 mg/ml) bolus of triamcinolone acetonide was injected in the posterior sub-Tenon's space using a curved sub-Tenon's blunt cannula mounted on a 1 ml syringe. The conjunctival opening was closed with 10–0 nylon suture. A subconjunctival injection of 0.5 ml of dexamethasone (4 mg/2 ml) and 0.5 ml of gentamycin (80 mg/2 ml) was given at the end of surgery.

Group 2 (control group): The same surgical steps as the study group including subconjunctival injection of dexamethasone and antibiotic were performed, but no STA was administered.

Postoperative treatment

All children were examined at the slit lamp. In Group 1, only topical antibiotic eyedrops (chloramphenicol 0.5%) were administered 4 times a day to the operated eye and stopped after 1 week. This is the routine postoperative antibiotic regimen in our institution. Patients were discharged from hospital on the first postoperative day. In Group 2, operated eyes were put on 1 hourly prednisolone acetate 1% eyedrops, chloramphenicol eyedrops (0.5%) 4 times a day, and tropicamide (0.5%) eyedrops once a day. Patients were discharged on the 4th postoperative day after satisfactory training of parents in the art of instilling the medications. The topical steroid was gradually tapered and stopped over a month. Topical antibiotic and mydriatic were stopped at the end of week 1.

At each postoperative visit, the child had a complete slit-lamp examination including dilated fundus examination. IOP was checked in the similar manner and with the same instrument as during the preoperative examination. The conjunctival suture placed at the STA site was removed at 1-week postoperatively at the slit-lamp or under oral sedation with magnification as an out-patient procedure.

Statistical analysis

Descriptive statistics (mean ± standard deviation) were used to report normally distributed continuous variables. Nonnormal variables were reported using Median (interquartile range [IQR]). Frequency, percentage, and Chi-square test were used for categorical variables. Comparison between the two arms was done using the independent sample t-test.


   Results Top


A total of 23 patients were operated in the period mentioned of which five children were excluded as three had traumatic cataract, one had Marfan's syndrome, and one had trichothiodystrophy. Parents of 12 children with bilateral cataract and six children with unilateral cataract consented to participate in the study. A total of 18 children (30 eyes) were included with a male: female ratio of 1:1.2. The mean age was 45.44 ± 43.55 months {Median 30, IQR (11,84)} and 42 ± 39.69 months in Group 1 and Group 2, respectively (age range 1–132 months) (P = 0.8) at the time of surgery. [Table 1] shows the number of eyes in the Group 1 (study group, n = 18 eyes) and Group 2 (control group, n = 12 eyes) by age. Gender distribution was similar in both groups (P = 0.7). All 30 eyes had a minimum postoperative follow-up of 3 months. The distribution of eyes versus type of surgical procedure is shown in [Table 2].
Table 1: Distribution of eyes in the two groups according to age

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Table 2: Number of eyes underwent different surgical procedure

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The mean preoperative IOP in Group 1 was 10.9 ± 2.5 mmHg and in Group 2 was 9.9 ± 1.9 mmHg (P = 0.3). [Figure 1] shows the mean preoperative IOP of the two groups. The mean postoperative IOP in Group 1 and Group 2 is as shown in [Table 3]. The mean postoperative IOP of the two groups is shown graphically in [Figure 2].
Figure 1: Box-plot showing the mean preoperative intraocular pressure in both groups

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Table 3: The mean postoperative intraocular pressure between the two groups

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Figure 2: Box-plot showing the mean postoperative intraocular pressure in both groups

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There was one child with bilateral cataract who had postoperative IOP >30 mmHg in both eyes which was managed medically. The remaining subjects did not show any significant rise in IOP. Recordings of 1st postoperative day IOP could not be obtained in 2 eyes in Group 1 and 1 eye in Group 2.

On the first postoperative day, in Group 1, there was cellular reaction of 1+ cells in all 18 eyes whereas in Group 2, there was a cellular reaction of 1+ cell in eight eyes (67%), 2+ cells in one eye (8%), and exudative strands in the pupillary axis in three eyes (25%). In the 1st postoperative week review, only 1 eye (5.5%) in Group 1 had pigment deposits on the IOL as opposed to six eyes (50%) in Group 2. This was statistically significant (P = 0.009). On subsequent follow-up, at 3 months, two eyes (16.6%) in Group 1 developed posterior synechiae and six eyes (50%) in Group 2 developed posterior synechiae (P = 0.03) of which five eyes were of children ≤1 year of age and the 6th child was a 7-year-old with delayed milestones. Irregular pupil was seen in four of the six eyes in Group 2 and none in Group 1. Posterior capsular opacification was absent in both groups at the 3 months follow-up. Implantation of an IOL as opposed to leaving the eye aphakic had no role in postoperative inflammation in the two groups (P = 1.0).


   Discussion Top


The established practice to control postcataract surgery inflammation in adults and children has been to use intense corticosteroid medications such as topical eyedrops, ointments, and oral preparations. Newer methods of drug delivery such as periocular and intraocular injections are being tried with some success.[8],[21],[24],[25]

Periocular and intravitreal injections of steroids have resulted in steroid-induced glaucoma[26] due to their prolonged duration of action. In the literature, the effect on IOP due to the intraoperative use of TA in controlling postoperative cataract surgery inflammation has had mixed reports.[8],[13],[21],[27],[28],[29] In our study, we chose to administer triamcinolone acetonide through a posterior sub-Tenon's route as it is shown to have less effect on IOP than the anterior sub-Tenon's route.[26] We did not have any statistically significant difference in preoperative and postoperative IOP. We had only one child (1-month-old) with bilateral cataract and underwent surgery for the same according to the study protocol. Postoperatively, both eyes showed rise in IOP, which was successfully managed with only topical antiglaucoma medications.

Our study showed triamcinolone acetonide to be effective in controlling anterior segment inflammation similar to reports in literature.[8],[12],[13],[15],[21],[24],[27],[28],[29],[30] Nearly 50% (six out of 12 eyes) in Group 2 developed posterior synechiae 3-months postoperatively compared to only two eyes in Group 1. We also used a single intraoperative injection of STA as a primary modality of treatment in Group 1 and none of these eyes were put on postoperative topical or systemic steroids unlike what has been reported in literature.[8],[12],[28] Our results demonstrate that STA is clinically effective as a primary modality for controlling postoperative intraocular inflammation in uneventful pediatric cataract surgery. The presence of IOL did not have an effect on ocular inflammation. We were, however, unable to perform a subgroup analysis according to age as the numbers were very less in some age groups.

The reported potential complications of posterior sub-Tenon's capsule injection of steroids include inadvertent injection into the retinal and choroidal circulation, globe perforation, central retinal artery occlusion, blepharoptosis, proptosis, and orbital fat atrophy.[21],[25] Rare complications include delayed hypersensitivity reactions, conjunctival hemorrhage, and infections.[31] Although our study was inadequately powered to detect these complications due to a small sample size, none of them occurred in this study. Our emphasis on careful technique with use of a blunt tipped cannula for STA and careful placement of the depot preparation in the posterior sub-Tenon's space may have helped to prevent these adverse occurrences. The limitation of our study was the small study population size and the lack of blinding of the follow-up observer.


   Conclusion Top


A posterior sub-Tenon's injection of 0.5 m1 of triamcinolone (40 mg/ml) in uneventful pediatric cataract surgery appears to be a safe route of steroid delivery. It seems to be effective as an alternative to hourly topical steroid medication and possibly suitable as the only modality of treatment in controlling postoperative inflammation in pediatric eyes where the compliance with topical medications is an issue. Further studies with randomization, blinding, a larger sample size, and longer follow-up are required to fully study the efficacy of this modality of treatment in pediatric cataracts.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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