570 Journal of the College of Physicians and Surgeons Pakistan 2009, Vol. 19 (9): 570-574

INTRODUCTION

Surgical manipulation during phacoemulsification leadsto the disruption of the blood aqueous barrier, resultingin intraocular inflammation. This can cause increasedintraocular pressure, adhesion of iris to angle, to thelens implant or lens capsule, deposits on implant,opacification of posterior capsule and visual impairment.1

Topical corticosteroids are known to be effective insuppressing postoperative inflammation.2 However,they have many side effects, like impaired woundhealing, elevation of intraocular pressure and increasedtendency of infections, tear-film instability, epithelialtoxicity, crystalline keratopathy and ptosis.3,4

Recent studies suggest that topical non-steroidal anti-inflammatory drugs (NSAIDs) are as effective ascorticosteroids in preventing disruption of orre-establishing the blood aqueous barrier followingcataract surgery.5,6,7 Polansky has reported that theadverse effects seen with topical corticosteroid have notbeen seen with NSAIDs.8 In spite of the side effects,corticosteroids are used routinely by almost allophthalmic surgeons to control post-cataract surgeryinflammation.9,10

The objective of this study was to compare post-operative anti-inflammatory effects of 0.1% diclofenacsodium and 0.1% dexamethasone eye drops in patients,following uneventful phacoemulsification surgery, usingposterior chamber intraocular lens implants.

METHODOLOGY

This study was conducted in the Department ofOphthalmology, PNS Shifa Hospital, Karachi, from June2006 to March 2007.

The study design was quasi-experimental. A non-probability, purposive sampling technique was used.Uncomplicated, senile cataract patients undergoingplanned phacoemulsification surgery with posteriorchamber IOL implants were included in the study. Anyoperative or postoperative complication, those takingtopical/oral steroids or NSAIDs, patients requiringpostoperative additional medication, ocular or systemicdiseases, and patients having history of ocular traumawere excluded.

Pre-operative evaluation included written, informedconsent from the subjects. They were admitted one daybefore surgery. A note of medical and ocular history wastaken including use of NSAIDs, steroids, ocular trauma,inflammation, amblyopia, glaucoma and cornealdiseases etc. All the subjects underwent a compre-hensive ophthalmic examination.

Pre-operative medications were started a night prior tothe surgery. Acetazolomide 250 mg and diazepam 5 mg

ABSTRACTObjective: To compare the effectiveness of dexamethasone and diclofenac sodium eye drops in the resolution ofinflammation following phacoemulsification surgery with posterior chamber intraocular lens implants. Study Design: Quasi-experimental study. Place and Duration of Study: Ophthalmology Department, PNS Shifa Hospital, Karachi, from June 2006 to March 2007. Methodology: One hundred subjects were operated and postoperatively divided into two groups, designated as‘dexamethasone’ and ‘diclofenac’ groups. They were assessed for visual acuity and followed for 5 weeks for the signs ofinflammation, which included cells and flare in the anterior chamber and striate keratopathy. Proportions were comparedby Fisher’s exact test and the chi-square test.Results: Topically applied diclofenac sodium suppressed postoperative inflammation effectively but its anti-inflammatoryeffects were of lesser magnitude as compared to that of topically applied dexamethasone drops (p < 0.005). Conclusion: Dexamethasone eye drops were found to have more potent anti-inflammatory activity in moderate to severecases than diclofenac sodium eye drops in postoperative cases.

Key words: Dexamethasone. Diclofenac sodium. Eye drops. Anti-inflammatory activity.

Department of Opthalmology, PNS Shifa Hospital, Karachi.

Correspondence: Surg. Cdre Muhammad Waseem, Head ofDepartment of Opthalmology, PNS Shifa Hospital, Karachi., E-mail: mwkhan@brain.net.pk

Received June 26, 2008; accepted March 31, 2009.

Comparison of Anti-Inflammatory Activity of Dexamethasoneand Diclofenac Sodium Eye Drops in Phacoemulsification

Muhammad Waseem and Sadia Humayun

ORIGINAL ARTICLE

were given to all the patients. Pre-operative mydriasiswas achieved with 1% tropicamide and 10%phenylephrine hydrochloride eye drops, four times inone hour at regular intervals. For local anaesthesia, 5 mlof 1:1 mixture of 2% Xylocaine (lignocaine HCL) and0.5% Bupicain (bupivacaine hydrochloride) was made;out of which 3 ml was used for facial block and 2 ml wasused for peribulbar anaesthesia. The eye was paddedfor 10-15 minutes.

The operative area was draped after cleaning withantiseptic lotion. The exposed eye ball/conjunctival sacwere irrigated with Ringer’s lactate solution. The anteriorchamber was entered at superotemporal limbus with a3.2 mm stainless steel angled keratome and filledwith 2% hydroxypropylmethylcellulose. Continuouscurvilinear capsulorrhexis was done with cystitome. A2 mm side-port incision for a second instrument wasmade at the 2 o’clock limbus. Hydrodissection andhydrodelineation was performed with a BalancedElectrolyte Solution (BES). Endocapsular phacoemulsi-fication and the nucleus aspiration were carried out.Aspiration of the residual cortical matter was done withSimco cannula. The anterior chamber was reformedwith 2% methylcellulose. The foldable acrylic lens wasloaded to the syringe insert and the lens slowly injectedinto the bag. Viscoelastic material was aspirated out.Intraocular Miostat 0.01% (carbachol) was used formiosis. The wound was left unstitched and anti-septicdressing done. All patients were operated upon by thesame surgeon with same technique.

Postoperative cases were randomized via assignmentto one of the two groups; “P-group” (dexamethasone)and “S-group” (diclofenac sodium), by a doctor nototherwise involved in the management of the patients.There were 50 eyes in each group to reduce theobserver bias, the observer and the patients weremasked from the contents of the bottle. On the firstpostoperative day, after removing the dressing, thepatient’s vision was checked and evaluated on slit lampfor corneal transparency, wound apposition, depth ofanterior chamber, cells and flare and the position of theintraocular lens. The cells and flare were graded from0 to 4. A uniform dosage schedule of one drop fourhourly during the first week in the operated eye, followedby one drop six hourly during subsequent weeks wasobserved. The patients were discharged next day andinstructed as to the regular use of prescribed medicines.

During follow-up, ocular examination was done on thefirst postoperative day and then at the end of the first,third and fifth week postoperatively for visual acuity,striate keratopathy, anterior chamber cells and anteriorchamber flare. The findings so obtained were entered ina pre-designed proforma.

For data analysis, SPSS version-10 was used.Frequencies and percentages were computed topresent all categorical variables. The chi-square testwas applied to compare the proportions of postoperativeoutcome with that of pre-operative findings (to testalternate hypothesis) between two groups at p < 0.05level of significance for qualitative factors. Baselinecomparisons of quantitative data between groups weremade using the independent sample t-test. Alpha forsignificance was set at p ≤ 0.05. All tests of hypotheseswere two-tailed.

RESULTS

One hundred patients participated in the study; fiftyreceived dexamethasone 0.1% eye drops and anotherfifty received diclofenac sodium 0.1% eye dropstopically. In the diclofenac group, 3 patients had severeanterior segment inflammation and had to be given oralsteroids and excluded from the study.

The dexamethasone group consisted of 32 males (64%)and 18 females (36%) while the diclofenac groupincluded 27 males (57.4%) and 20 females (42.6%).Two groups were similar in gender distribution (p =0.539).

The mean (SD) age in the dexamethasone group was61.68 (+9.78) years and in the diclofenac group was59.915 (+10.734) years. The two groups werecomparable in age (t = 0.847, df = 95, p = 0.399).

The visual acuity (Table I) was comparable pre-operatively between the two groups (chi-square = 4.450,df = 6, p = 0.616). The visual acuity distribution did notvary significantly between the two groups after the firstday (chi-square = 7.448, df = 8, p = 0.489), first week(chi-square = 5.469, df = 6, p = 0.485), three weeks (chi-square = 1.926, df = 4, p = 0.749) or five weekspostoperatively (chi-square = 2.157, df = 4, p = 0.707).

The anterior chamber cell count (Table II) was notcomparable postoperatively between the two groups onthe first day (chi-square = 25.549, df = 3, p < 0.001 atα = 0.05) and first week (chi-square = 16.954, df = 2,p < 0.001 at α = 0.05) where dexamethasone showed abetter anti-inflammatory response than the diclofenacgroup. The anterior chamber cell distribution did not varysignificantly between the two groups at 3 weeks (chi-square = 4.871, df = 2, p = 0.088) or 5 weeks post-operatively (p = 0.610).

The flare (Table III) between the two groups was notdifferent when analyzed at the first postoperative day(chi-square = 5.579, df = 2, p = 0.061) and the first post-operative week (p = 0.426) while flare was not presenton the third week postoperatively and beyond.

On the first day and first week postoperatively, thestriate keratopathy (Table IV) distributions were not the

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Comparison of anti-inflammatory activity of dexamethasone and diclofenac sodium eye drops in phacoemulsification

same- with dexamethasone showing a better responsethan the diclofenac group (first day chi-square = 15.876,df = 2, p <.001, first week p = 0.028. The response ofboth the drugs became similar from 3 weeks onwards(third week chi-square = 4.660, df = 8, p = 0.793; fifthweek chi-square = 5.639, df = 8, p = 0.688).

The patients were divided into grades of severity(Table V), which was a composite variable includinganterior chamber cells and flare. It was found that theresponse of dexamethasone was better in terms ofdecreasing the overall severity than diclofenac (chi-square = 10.923, df = 2, p < 0.005).

572 Journal of the College of Physicians and Surgeons Pakistan 2009, Vol. 19 (9): 570-574

Muhammad Waseem and Sadia Humayun

CF=Counting finger; P-Group=Dexamethasone; S-Group=Diclofenac sodium; VA=Visual acuity.

Table I: Visua acuity: analysis between the two groups.

CF=Counting finger; Occ=Occasional; P-value=Probability value.

Table II: AC cells: analysis between the two groups.

DISCUSSION

Studies have shown that some of the NSAIDs are aseffective as steroids in controlling inflammation aftercataract surgery.11,12 This study was done on Pakistanipatients with brown irises and demonstrated beneficialeffects with both diclofenac sodium (0.1%) anddexamethasone phosphate (0.1%). This showed thattopically applied diclofenac sodium suppressespostoperative inflammation effectively but to a lessermagnitude than topically applied dexamethasone drops.Moreover, topical corticosteroids need not be routinelyused in uncomplicated cataract surgery. However, inmoderate to severe cases, dexamethasone appeared tobe superior. Farooq and Ali found that in mild cases ofpostoperative inflammation, ophthalmic Flurbiprofen iscomparable to ophthalmic dexamethasone but formoderate to severe cases of postoperative inflammationdexamethasone is superior to the former. Joint use ofboth in postoperative cases is more efficacious than

either of them in resolution of both of the AC activity aswell as striate keratopathy.13

In a study between diclofenac sodium and dexa-methasone, Reddy et al. found that the treatment effectsfor any of the variables including aqueous cells, flare,ciliary congestion, descemets' folds and intraocularpressure did not show statistical difference three weekspostoperatively.14 However, there was a trend towardsquicker improvement in the dexamethasone group whencells in the anterior chamber were considered. Inanother study by Missotten et al. a difference in thepostoperative signs was in favour of indomethacin, buthyperemia was less pronounced in the dexamethasonegroup one month postoperatively.15 Diestelhorst et al.showed that flurbiprofen was less effective thandiclofenac and indomethacin, in a postoperativeperiod.16

This study included patients having no preoperativeinflammatory disease and surgery was uneventful in allthe patients of both groups, the effectiveness of topicaldiclofenac versus dexamethasone in complicatedcataract surgery remained undetermined and therefore,would need a separate study.

CONCLUSION

The resolution of inflammation was quicker in thedexamethasone group than in the diclofenac group. Thiseffect was more marked in moderate to severe cases.Although dexamethasone seemed to be superior in theresolution of anti-inflammatory activity, the use ofdiclofenac sodium may be considered in mild cases ofpostoperative inflammation.

REFERENCES1. El-Harazi SM, Feldman RM. Control of intra-ocular inflammation

associated with cataract surgery. Curr Opin Ophthalmol 2001; 12:4-8.

2. Ferguson VM, Spalton DJ. Continued breakdown of the bloodaqueous barrier following cataract surgery. Br J Ophthalmol 1992;76:453-6.

3. Havener H. Ocular therapeutics. In: Pernan GA, Sandle DR,Goldberg MF, editors. Principles and practice of ophthalmology.19th ed. Philadelphia: W.B. Saunders; 1980.p.757- 68.

4. McGhee CN, Dean S, Danesh-Meyer H. Locally administeredocular corticosteroids: benefits and risks. Drug Saf 2002; 25:33- 55.

5. Russo P, Papa V, Russo S, Di Bella A, Pabst G, Milazzo G, et al.Topical non-steroidal anti-inflammatory drugs in uncomplicatedcataract surgery: effect of sodium naproxen. Eur J Ophthalmol2005; 15:598-606.

6. Simone JN, Whitacre MM. Effects of anti-inflammatory drugsfollowing cataract extraction. Curr Opin Ophthalmol 2001; 12:63-7.

7. Flach AJ. Non-steroidal anti-inflammatory drugs. In: Tasman W,Jaegar EA, editors. Duane’s ophthalmology on CD-ROM edition.Philadelphia: Lippincott Williams & Wilkens; 2005.

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Table III: Flare: analysis between the two groups.

Table V: Severity grade: post-op analysis.

Table IV: Striate keratopathy: analysis between the two groups.

SK=Striate keratopathy.

8. Polansky JR. Side-effects of topical therapy with anti-inflammatory steroids. Curr Opin Ophthalmol 1992; 3:259-72.

9. Goa KL, Chrisp P. Ocular diclofenac. A review of itspharmacology and clinical use in cataract surgery, and potentialin other inflammatory ocular conditions. Drugs Aging 1992; 2:473- 86.

10. Goquen E, Roberts C. Perioperative pharmacology in cataractsurgery. Insight 2005; 30: 23-8.

11. Laurell CG, Zetterström C. Effects of dexamethasone,diclofenac, or placebo on the inflammatory response aftercataract surgery. Br J Ophthalmol 2002; 86:1380-4.

12. Shamim SM, FarIda I. Diclofenac sodium: effects and adverseeffects. Ann Abbasi Shaheed Hosp Karachi Med Dent Coll 2000; 5:169-74.

13. Farooq Q, Ali SI. Comparison of anti-Inflammatory activity ofofloxacin + dexamethasone eye drops and flurbiprofen eyedrops in postoperative cases. Pak J Ophthalmol 2003; 19:122-9.

14. Reddy MS, Suneetha N, Thomas RK, Battu RR. Topicaldiclofenac sodium for treatment of postoperative inflammation incataract surgery. Indian J Ophthalmol 2000; 48:223-6.

15. Missotten L, Richard C, Trinquand C. Topical 0.1%indomethacin solution versus topical 0.1% dexamethasonesolution in the prevention of inflammation after cataract surgery.The Study Group. Ophthalmologica 2001; 215: 43- 50.

16. Diestelhorst M, Schmidl B, Konen W, Mester U, Raj PS. Efficacyand tolerance of diclofenac sodium 0.1%, flurbiprofen 0.03%and indomethacin 1.0% in controlling postoperativeinflammation. J Cataract Refract Surg 1996; 22:788-93.

574 Journal of the College of Physicians and Surgeons Pakistan 2009, Vol. 19 (9): 570-574

Muhammad Waseem and Sadia Humayun

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