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   Table of Contents      
ORIGINAL ARTICLE
Year : 2007  |  Volume : 55  |  Issue : 4  |  Page : 271-275

Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response


Institute of Ophthalmology, (Gandhi Eye Hospital Campus), JN Medical College, Aligarh Muslim University, Aligarh - 202 001, UP, India

Date of Submission13-Sep-2006
Date of Acceptance13-Feb-2007

Correspondence Address:
Abadan K Amitava
Institute of Ophthalmology, 4/758 Taban Cottage, Friends Colony, Dodhpur, Aligarh - 202 001
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0301-4738.33039

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  Abstract 

Background: Compared to steroids non-steroidal anti-inflammatory drugs offer comparable anti-inflammatory action without ocular side-effects.
Aim: To compare the anti-inflammatory effect and effect on IOP (Goldmann) of topical diclofenac 0.1% with dexamethasone 0.1% after strabismus surgery.
Design: Prospective, randomized, double-blind, single-center, clinical trial.
Materials and Methods: Forty-three cases of constant horizontal strabismus, qualifying for standard uniocular recession-resection surgery on two horizontal rectus muscles were randomized to either the dexamethasone or diclofenac group. They were excluded if they had previous ocular surgery, recently used anti-inflammatory drugs and had a neurological, systemic or an ocular inflammatory condition. In addition all received ciprofloxacin 0.3% four times daily. Assessment was done on the first postoperative day and at two and four weeks. The inflammatory characteristics graded from nil (0) to severe (3) were: discomfort, chemosis, injection, discharge and drop-intolerance. Their sum provided the total inflammatory score (TIS).
Results: Dexamethasone group (n=21) was comparable in age, gender, preoperative IOP, strabismus, anesthesia administered and baseline IOP, to diclofenac (n=22). There were no significant differences in the inflammatory characteristics and TIS. The dexamethasone group had IOP significantly higher at two weeks (95% CI 0.17 to 3.25) and four weeks (95% CI 1.09 to 4.24) compared to diclofenac group and the net change of IOP at four weeks (95% CI 0.60 to 3.14). Compared to the baseline IOP.
Conclusion: Topical diclofenac is comparable to dexamethasone in providing anti-inflammatory and analgesic effect with the advantage of significantly lesser IOP rise and should be preferred after strabismus surgery.

Keywords: Clinical trial, dexamethasone, diclofenac, intraocular pressure, strabismus surgery


How to cite this article:
Khan HA, Amitava AK. Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response. Indian J Ophthalmol 2007;55:271-5

How to cite this URL:
Khan HA, Amitava AK. Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response. Indian J Ophthalmol [serial online] 2007 [cited 2020 Feb 27];55:271-5. Available from: http://www.ijo.in/text.asp?2007/55/4/271/33039

Table 3: Clinical parameters of the two groups at follow-up on day 1, week 2 and week 4 postoperatively

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Table 3: Clinical parameters of the two groups at follow-up on day 1, week 2 and week 4 postoperatively

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Table 2: Infl ammatory grades of the dexamethasone and diclofenac groups during follow-up

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Table 2: Infl ammatory grades of the dexamethasone and diclofenac groups during follow-up

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Table 1: Baseline demographic and clinical characteristics of trial groups

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Table 1: Baseline demographic and clinical characteristics of trial groups

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Although the non-steroidal anti-inflammatory drugs (NSAIDs) have almost replaced steroids in providing an effective anti-inflammatory alternative after cataract surgery, [1],[2],[3],[4] this is not so following strabismus surgery. In a 1997 survey of strabismologists more than 90% respondents were using topical corticosteroids after surgery. [5] Since steroids are associated with risks of delayed wound healing, [6] decreased resistance to infections and intraocular pressure (IOP) elevations, [7],[8] it is prudent to replace them with a safer alternative. Only recently have NSAIDs been considered equally effective in controlling postoperative pain and inflammation in strabismus surgery. [9],[10],[11],[12]

We designed a prospective, randomized, double-blind, single-center, clinical trial to compare the anti-inflammatory action of topical diclofenac sodium (0.1% ophthalmic solution) with topical dexamethasone (0.1% ophthalmic solution) after strabismus surgery. The main outcome measure was the evaluation of the inflammatory response and the secondary outcome was the IOP during follow-up.


  Materials and Methods Top


After approval from the faculty ethical committee and obtaining an informed consent, 48 consecutive patients, referred to the strabismus clinic were included. The cases were recruited if they had constant strabismus and needed uniocular recession-resection surgery on two horizontal rectus muscles. They were not enrolled if any of the following criteria were present: (1) a history of strabismus surgery, (2) underwent > two muscle surgery or bilateral surgery, (3) too young to cooperate with IOP assessment or to provide an adequate response to our pre-tested questionnaire, (4) a known hypersensitivity to the drugs used in the study, (5) neurological anomaly or systemic disorder, (6) ocular inflammatory condition, whether active or healed or (7) use of systemic anti-inflammatory drugs in the last four weeks.

Baseline parameters were recorded. All cases were operated in a similar manner by a single surgeon (AKA). Ciprofloxacin 0.3% four times daily was instilled into the eye starting a day prior to surgery and was continued postoperatively for four weeks. Children were operated under inhalational halothane and the adults under standard peribulbar anesthesia. The horizontal rectus muscles were approached via Von Noorden's limbal conjunctival incisions, 6mm long and concentric with the limbus, extended by two radial cuts posteriorly 5mm in length. No cautery was used. Muscle-scleral attachments were made with 6/0 Vicryl (Ethicon; NW 2670), while the conjunctival closure was obtained by 8/0 Vicryl (Ethicon; NW 2348), using buried knots with four sutures. Block randomization (in blocks of six) was done to allocate the cases to receive either dexamethasone sodium 0.1% (NSAID: Syntho Pharmaceuticals Pvt. Ltd., Lucknow) or diclofenac sodium 0.1% eye drops (Solodex: Jawa Pharmaceutical Pvt. Ltd., Gurgaon), in identical vials. The nature of the drug was masked from the patients, the surgeon and the assessor by removing the labels from similar 5ml bottles and sealing three such bottles in one opaque sachet. Patients were given identical instructions to instill the study drops four times a day for four weeks. The unmasking was done at the time of the final analyses after the data collection was completed.

The patients were evaluated on the first postoperative day and at two and four weeks after surgery. The conjunctival injection over the site of muscle attachments was graded objectively by comparing against a series of color photographs. Inflammatory symptoms were analyzed subjectively by a questionnaire assessing patient discomfort, discharge and drop intolerance. Chemosis was graded as absent to severe. Inflammatory parameters were scored as: 0 (nil), 1 (mild), 2 (moderate) or a 3 (severe) response. Additionally, we algebraically added the grading of the five inflammatory characteristics to arrive at a total inflammatory score (TIS): possible range 0 (minimum) to 15 (maximum). The IOP was recorded by Goldmann applanation tonometer. For each subject, at each follow-up, we calculated the difference in IOP from baseline, to evaluate the net change in IOP. Any patients not available at two-week or four-week follow-up, were considered as lost to follow-up and excluded from the analyses.

Since the main outcome variables were graded responses, to be analyzed by the non-parametric test, we considered that a minimum of 20 patients in each group would suffice for the study. Statistical analyses were performed using SPSS for Window, Version 10. Bivariate data were analyzed by chi square statistic, while continuous (parametric) and graded variables (non-parametric) were subjected to t-test and the Mann Whitney U test respectively. Significance was set at P ≤ 0.05.


  Results Top


Of the 87 patients initially assessed for the study, five refused consent and 34 did not meet the inclusion criteria [Figure - 1]. The remaining 48 patients were randomized (24 in each group). Five were lost to follow-up. We thus finally analyzed 43 cases: 21 in the dexamethasone group and 22 in the diclofenac group. The groups were comparable in their baseline characteristics, including preoperative IOP [Table - 1]. The subjects were analyzed on intention to treat basis.

The two groups were comparable in age, gender, preoperative IOP, amount and type of strabismus, proportion with onset prior to five years-age and proportion undergoing strabismus surgery under general anesthesia [Table - 1]. Surgery was uncomplicated in all cases.

[Table - 2] depicts the graded response to each of the five inflammatory variables under study at follow-up. No significant differences were observed on the Mann-Whitney U test ( P >0.05). The TIS was comparable throughout the follow-up [Table - 3]. On the first postoperative day, there was no significant difference in the IOP between the two groups ( P =0.36) [Table - 3]. The mean IOP in the dexamethasone group was significantly higher at two weeks ( P =0.03, 95% CI for difference 0.17 to 3.25) and at four weeks ( P =0.002, 95% CI for difference 1.09 to 4.24) compared to the diclofenac group. The net rise of IOP from baseline was statistically significant only at four weeks (µ rise: 1.07, 95% CI 0.60 to 3.14).


  Discussion Top


Similar to our result, no statistical difference in discomfort level has been reported by others. [9],[10],[11] Although Apt et al . [12] arrived at a similar conclusion, they used oral analgesics in both the groups. Snir [10] reported a significantly lesser discomfort (and pain) at two weeks ( P = 0.003) and at four weeks ( P = 0.02) with diclofenac.

Akin to us, previous studies have [11],[12] failed to detect any significant difference for chemosis and injection. In contrast Snir et al . [10] found significantly less chemosis ( P = 0.02) and inflammation ( P = 0.04) in the diclofenac group at two weeks, but this did not persist until the fourth week postoperatively. Apt et al . [12] evaluated discharge between the two groups, although only until one week postoperatively. Like us, they found no significant dissimilarity between the two groups.

We could not find any study which explicitly discussed drop intolerance. Wright et al . [9] may have referred to it where they report that both the treatments were well tolerated with parents reporting either no or only mild discomfort after instillation of eye drops with no difference between groups. Unfortunately, this is a subjective variable and imprecisely recorded, especially in cases of children. Our study, it may be argued would score marginally better because the older age group may yield a clearer response to such a query. We failed to detect any significant difference between the two groups for drop intolerance. It is important to point out that the preservatives were different in the two groups: diclofenac having benzalkonium chloride 0.02% and dexamethasone having phenyl mercuric nitrite 0.001%. There thus remains a possibility that despite their small quantities, they may influence and confound this outcome.

Wright et al . [9] used total inflammatory scores to compare betamethasone-neomycin and diclofenac-gentamycin groups. Similarly, we used a standard series of clinical photographs to grade and compare injection over the site of muscle surgery thereby increasing objectivity in the assessment. We failed to demonstrate any significant difference in the TIS between the two groups at any point during four weeks of follow-up.

Similar to our results, other authors [10],[11] have demonstrated statistically significant ocular hypertensive response to dexamethasone compared to diclofenac after strabismus surgery. The ocular hypertensive response may be greater in children on account of the immaturity of the trabecular meshwork. [13] This implies that an immature trabecular meshwork may have a greater predisposition to a hypertensive response to steroids. Since more than 88% of our cases were older than 10 years and thus have a more mature trabecular meshwork compared to children, this could explain the lack of any clinically meaningful ocular hypertensive response in the present study.

We lacked a 'no treatment arm', the importance of which is brought out by Wortham et al . [14] when they demonstrated that the anti-inflammatory response to prednisolone 1% was equivalent to a placebo (polyvinyl alcohol 0.4%). Unfortunately our study did not include a further follow-up to identify the time period when the IOP in the two groups became equivalent.

It is concluded that instillation of diclofenac 0.1% drops after strabismus surgery is comparable to dexamethasone 0.1% in providing anti-inflammatory and analgesic effect and has the advantage of significantly lesser rise of intraocular pressure.

 
  References Top

1.
Fry LL. Efficacy of diclofenac sodium in reducing discomfort after cataract surgery. J Cataract Refract Surg 1995;21:187-90.  Back to cited text no. 1
    
2.
Missotten L, Richard C, Trinquand C. Topical 0.1% indomethacin solution versus topical 0.1% dexamethasone solution in the prevention of inflammation after cataract surgery. The Study Group. Ophthalmologica 2001;215:43-50.  Back to cited text no. 2
    
3.
Herbort CP, Jauch A, Othenin-Girard P, Tritten JJ, Fsadni M. Diclofenac drops to treat inflammation after cataract surgery. Acta Ophthalmol Scand 2000;78:421-4.  Back to cited text no. 3
    
4.
Laurell CG, Zetterstrom C. Effects of dexamethasone, diclofenac or placebo on the inflammatory response after cataract surgery. Br J Ophthalmol 2002;86:1380-4.  Back to cited text no. 4
    
5.
Olitsky SE, Awner S, Reynolds JD. Perioperative care of the strabismus patient. J Pediatr Ophthalmol Strabismus 1997;34:126-8.  Back to cited text no. 5
    
6.
McDonald TO, Borgmann AR, Roberts MD, Fox LG. Corneal wound healing. I. Inhibition of stromal healing by three dexamethasone derivatives. Invest Ophthalmol 1970;9:703-9.  Back to cited text no. 6
    
7.
Ng JS, Fan DS, Young AL, Yip NK, Tam K, Kwok AK, et al . Ocular hypertensive response to topical dexamethasone in children: A dose-dependent phenomenon. Ophthalmology 2000;107:2097-100.  Back to cited text no. 7
    
8.
McGhee CN. Pharmacokinetics of ophthalmic corticosteroids. Br J Ophthalmol 1992;76:681-4.  Back to cited text no. 8
    
9.
Wright M, Butt Z, McIlwaine G, Fleck B. Comparison of the efficacy of diclofenac and betamethasone following strabismus surgery. Br J Ophthalmol 1997;81:299-301.  Back to cited text no. 9
    
10.
Snir M, Axer-Siegel R, Friling R, Weinberger D. Efficacy of diclofenac versus dexamethasone for treatment after strabismus surgery. Ophthalmology 2000;107:1884-8.  Back to cited text no. 10
    
11.
Dadeya S, Kamlesh. Comparative evaluation of diclofenac and dexamethasone following strabismus surgery. J Pediatr Ophthalmol Strabismus 2002;39:166-8.  Back to cited text no. 11
    
12.
Apt L, Voo I, Isenberg SJ. A randomized clinical trial of nonsteroidal eye drop diclofenac after strabismus surgery. Ophthalmology 1998;105:1448-54.  Back to cited text no. 12
    
13.
Ohji M, Kinoshita S, Ohmi E, Kuwayama Y. Marked intraocular response to installation of corticosteroids in children. Am J Ophthalmol 1991;112:450-4.  Back to cited text no. 13
    
14.
Wortham E 5 th , Anandakrishnan I, Kraft SP, Smith D, Morin JD. Are antibiotic-steroid drops necessary following strabismus surgery? A prospective, randomized, masked trial. J Pediatr Ophthalmol Strabismus 1990;27:205-7.  Back to cited text no. 14
    


    Figures

  [Figure - 1]
 
 
    Tables

  [Table - 1], [Table - 2], [Table - 3]


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