|Year : 2000 | Volume
| Issue : 3 | Page : 223-6
Topical diclofenac sodium for treatment of postoperative inflammation in cataract surgery
MS Reddy, N Suneetha, RK Thomas, RR Battu
Dept. of Ophthalmology, St. John's Medical College and Hospital, Sarjapur Road, Bangalore-560 034, India
M S Reddy
Dept. of Ophthalmology, St. John's Medical College and Hospital, Sarjapur Road, Bangalore-560 034
Source of Support: None, Conflict of Interest: None
Purpose: To study the effect of a topical non-steroidal anti-inflammatory drug as an alternative to topical steroids for postoperative control of inflammation in cataract surgery.
Methods: The effect of diclofenac sodium 0.1% following cataract surgery was studied and compared to routine corticosteroid, dexamethasone phosphate 1% in a prospective, double-blind randomized study. Both groups were similar in baseline parameters. Postoperative inflammatory response, intraocular pressure and best-corrected visual acuity following standard extracapsular cataract extraction were assessed in both groups in the initial 21 days and the severity of these parameters was graded.
The severity of postoperative inflammatory response to the two drugs was graded at 1, 3, 7, 14 and 21 days. Intraocular pressure and visual acuity at baseline and endpoint were compared and statistically analyzed.
Results: The two groups did not differ statistically in treatment effect for any of the variables including aqueous cells, flare, ciliary congestion, Descemet's folds, visual acuity and intraocular pressure (p< 0.001). However there seemed to be a trend towards quicker improvement with corticosteroid when cells in the anterior chamber were considered. There were no side effects from topical diclofenac, and it was well tolerated.
Conclusion: Dicfofenac sodium is as effective as topical corticosteroid and can be used as an alternative in routine postoperative treatment following uncomplicated cataract surgery.
Keywords: Anterior Chamber, pathology, Anti-Inflammatory Agents, Non-Steroidal, administration & dosage, Cataract Extraction, adverse effects, Cell Count, Comparative Study, Dexamethasone, administration & dosage
|How to cite this article:|
Reddy M S, Suneetha N, Thomas R K, Battu R R. Topical diclofenac sodium for treatment of postoperative inflammation in cataract surgery. Indian J Ophthalmol 2000;48:223
|VISUAL ACUITY DID NOT DIFFER SIGNIFICANTLY ACROSS THE TWO GROUPS (T=0.70, DF=47, NS).|
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Topical steroids have been the mainstay of treatment of postoperative anterior segment inflammation, such as iridocyclitis. Non-steroidal anti-inflammatory drugs (NSAIDs) have been used less frequently. Diclofenac sodium (0.1%), a potent NSAID, has been used to treat postoperative inflammation following cataract surgery,[1-4] radial keratotomy, and argon laser trabeculoplasty. It has been shown to be as effective as topical corticosteroids in controlling ocular inflammation with minimal risk to the eye including elevation of intraocular pressure, and the risk of aggravating ocular infection. The additional advantages with NSAIDs are analgesia and sustained pupillary dilatation, both requisites for most intraocular surgeries. Cystoid macular oedema that may be seen in the postoperative period occurs less frequently with use of topical and oral NSAIDs. [9, 10] These drugs have been used to treat intraocular as well as extraocular inflammation. Animal studies have shown that NSAIDs are inhibitors of arichidonic pathway. They limit fibroblast activity and reduce inflammation. Topical NSAIDs offer an alternative to topical corticosteroids for treatment of ocular inflammation following cataract surgery. Commonly used NSAIDs include flurbiprofen, indomethacin, ketorolac and diclofenac sodium. Diclofenac sodium appears to be more potent than flurbiprofen and indomethacin in controlling postoperative inflammation and is also better tolerated.
|VISUAL ACUITY DID NOT DIFFER SIGNIFICANTLY ACROSS THE TWO GROUPS (T=0.70, DF=47, NS).|
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A prospective double-blind study of efficacy and tolerability of diclofenac sodium (0.1%) versus conventional steroid - dexamethasone phosphate (0.1%) in treatment of postoperative inflammation following extracapsular cataract extraction with intraocular lens (ECCE+IOL) implantation, was undertaken as a drug trial study on patients from the Department of Ophthalmology, St. John's Medical College Hospital, Bangalore, from September 1996 to January 1997. Approval for the study was obtained from the hospital ethics committee.
| Materials and Methods|| |
Sixty patients with senile cataracts who underwent uncomplicated ECCE with posterior chamber intraocular lens (PCIOL) implantation operated by four experienced surgeons were enrolled in the study after obtaining informed consent.
The inclusion and exclusion criteria were as follows:
Patients > 25 years age
ECCE-PCIOL surgery - uncomplicated
Intraocular pressure (IOP) > 24 mmHg
Eyes receiving other medications
Previous intraocular surgery
Insulin - dependent diabetes
Patients who had used NSAIDs in past 2 weeks
Patients allergic to NSAIDs
Patients who developed intraoperative complications
Patients who fulfilled the study selection criteria underwent a detailed slitlamp examination, measurement of intraocular pressure (Schiotz) and assessment of Snellen visual acuity.
The intraocular surgery was a standard ECCE, and PCIOL implantation. Briefly it consisted of corneoscleral incision, envelope type of anterior capsulotomy, nucleus delivery, and irrigation aspiration of cortical matter, insertion of a polymethylmethacrylate (PMMA) IOL (Epoch Lenses, Allergan India, Bangalore in the capsular bag and wound closure using 10-0 monofilament nylon. Methylcellulose, the viscoelastic substance used (IGEL, International Medical Devices Gurgaon, India) was removed at the end of surgery. The study medications, topical diclofenac sodium (0.1%) or dexamethasone phosphate (0.1%) were administered in a randomized double-blind fashion. Randomization was done using computer generated schedule and patients were allotted to one of the treatment schedules. Tropicamide 1% was used for all patients for preoperative dilatation and included in the postoperative regimen. Patients, nursing staff and surgeons were masked to the topical medications. Enough care was taken to supply the topical medications (drug and placebo) to the study patients in identically sealed bottles.
The postoperative topical medication, instilled six times a day, was continued for 21 days after surgery. Ten patients were withdrawn from the study for following reasons: In the diclofenac group, one patient developed wound gape with iris prolapse, one had severe reaction necessitating use of oral steroids and three were irregular for follow up. In the steroid group, three patients had severe anterior segment inflammation and had to be given oral steroids, while two patients were inconsistent for follow up. Patients were examined on days 1, 3, 7, 14 and 21 after surgery, and were graded on the following aspects: aqueous flare and cells in anterior chamber, conjunctival congestion, and corneal oedema. Severity of inflammation was graded on a 4-point scale ranging from 0-3, with a score of 3 reflecting the greatest severity of inflammation. Analgesia was subjectively estimated by questioning the patient about postoperative comfort.
| Statistical analysis|| |
The following tests were used to test for statistical significance:
- 1. Chi-square test for qualitative data with Yate's continuity correction for 2 x 2 contingency tables.
- 2. Baseline comparisons of quantitative data between groups were made using the independent sample t-test after confirming homogeneity of variances using the F-max test. Changes in scores / ratings across time were assessed using a two-way multivariate repeated measures analysis of variance with time of assessment as the within-subjects factor and drug category as the between-subjects factor.
- 3. Since visual acuity was rated at endpoint only, these scores were compared using the independent sample t-test, as above, at endpoint only.
Alpha for significance was set at p<0.05. All tests of hypotheses were two-tailed.
| Results|| |
Fifty patients were included for final analysis of inflammatory response to treatment with topical diclofenac sodium (0.1%) and dexamethasone phosphate (0.1%) following ECCE with IOL implantation. The diclofenac group consisted of 24 patients and the corticosteroid group consisted of 26 patients.
The mean (SD) age in the diclofenac group was 57.67 (9.21) years and in the corticosteroid group was 56.92 (9.44) years. The two groups were comparable in age (t=0.28 df=48, NS).
The diclofenac group included 10 males (41.67%) and 14 females (58.33%), while the corticosteroid group consisted of 6 males (23.08%) and 20 females (76.92%). The two groups were similar in gender distribution. (Chi square = 1.22, df=l, NS).
The IOP was comparable at baseline between the two groups (t=1.29, df=42, NS) and did not vary following treatment with either diclofenac sodium or dexamethasone phosphate.
All the patients on the trial showed good compliance to the drug. Though analgesia could not be adequately documented among all patients, most of them expressed no discomfort on instillation of either drug. There were no secondary infections encountered during the study period in the selected group. Pupillary dilatation could not be studied as tropicamide was used as a mydriatic drug for preoperative dilatation as well as for therapy in the postoperative period for all patients.
There were no adverse reactions observed with topical diclofenac sodium which might have necessitated withdrawal of the drug from use.
Data were analysed on days 3, 7, 14 and 21 after surgery, for signs of flare [Table - 1] and cells in the anterior chamber, [Table:2] conjunctival congestion [Table:3], and corneal oedema [Table:4]. This did not show any significant difference in anti-inflammatory activity between the two topical medications used. However, the time to achieve the anti-inflammatory activity was significant (p < 0.0001). The drug x time interaction was also not significant, indicating that the rate of improvement in the two drugs did not differ statistically. However, in terms of response of cells in the anterior chamber to the two drugs, the trend for improvement seemed to be faster and greater in magnitude with dexamethasone phosphate compared to diclofenac sodium. Best corrected visual acuity [Table:5] was assessed at endpoint only and the results between the two groups did not differ statistically.
| Discussion|| |
Diclofenac Sodium is a potent non-steroidal anti-inflammatory agent without the side effects of topical corticosteroids which may cause a rise in intraocular pressure, or delayed wound healing. Diclofenac sodium has been shown to be effective in controlling postoperative inflammation following intracapsular cataract extraction, extracapsular cataract extraction and phacoemulsification. Previous semi-quantitative studies have shown diclofenac sodium to be an effective anti-inflammatory agent. Quantitative evaluation using anterior chamber fluorophotometry, though ideal, is an invasive and laborious procedure. Laser flare cell photometers could provide objective information but unfortunately, are not readily available.
The slitlamp has been used in this study for evaluation. The primary criterion to indicate reduction of inflammatory response was reduction in flare and cells in the postoperative period (observed up to 21 days). Based on all the parameters used in this study including aqueous flare and cells in anterior chamber, conjunctival congestion, corneal oedema, IOP and final visual acuity patients in both groups showed comparable improvement. Patients in the corticosteroid group, however, showed marginal trend for faster and greater magnitude of improvement, with greater reduction in anterior chamber cells. This suggests that there could be a role for corticosteroids in patients with severe iridocyclitis in the psaostoperative period.
All published studies so far have been done on Caucasian patients. Our study has been done on Indian patients with brown irises. This study demonstrated similar beneficial effect with both diclofenac sodium (1%) and dexamethasone phosphate (0.1%). This study shows that topical corticosteroids need not be routinely used as anti-inflammatory agents especially in uncomplicated cataract surgery. This may help avoid complications like secondary infections, especially viral, and a rise of IOP in the occasional patients who are prone to it. There were no adverse reactions observed in any patient with diclofenac sodium during the study period.
In conclusion, NSAIDs are now accepted as a mode of postoperative treatment because of their anti-inflammatory properties, analgesia, and safety (particularly on IOP). With topical NSAIDs, there is also less likelihood of secondary infections.
The drawback of this study is that the trial has been conducted in patients with uncomplicated cataract surgery. It is not known whether diclofenac sodium is equally effective in treating inflammation associated with complications of cataract surgery. IOP was recorded with a Schiotz tonometer instead of the more ideal applanation tonometer. As this is a pilot study, on a limited number of patients, conclusions drawn here must be confirmed with a larger study.
| Acknowledgements:|| |
We would like to thank Cipla Ltd. for providing the drugs used in the study; Dr. Sujatha and Dr. Gogtony J. for coordinating the study; and Dr. Chittaranjan Androde for statistical assistance.
| References|| |
Othenin-Girard P, Tritten J J, Pittet N, Herbort P.Dexamethasone versus diclofenac sodium eyedrops to treat inflammation after cataract surgery. J Cataract Refract Surg
Flach AJ, Dolan BJ, Donahue ME, Faktorovich EG, Gonzalez GA. Comparative effects of Ketoralac 0.5% or Diclofenac 0.1% ophthalmic solutions on inflammation after cataract surgery. Ophthalmology
Kraff MC, Martin RG, Neumann AC, Weinstein AJ. Efficacy of dicofenac sodium ophthalmic solution versus placebo in reducing inflammation following cataract extraction and posterior chamber implantation. J Cataract Refract Surg
Suharwardy J, Ling C, Bell J, Munton CG. A comparative trial between diclofenac gentamicin and betamethasone-neomycin drops in patients undergoing cataract extraction. Eye
Epstein RL, Laurence EP. Effect of topical diclofenac solution on discomfort after radial keratotomy. J Cataract Refract Surg
Hebort CP, Mermoud A, Schnyder C, Pitet N. Anti-inflammatory effect of diclofenac drops after laser trabeculoplasty. Arch Ophthalmol
Bonomi L, Perfetti S, Belluci R., Massa F, De Franco J. Prevention of surgically induced miosis by diclofenac eye drops. Ann of Ophthalmol
Ku EC, Lee W, Kothari HV, Scholer DW. Effect of diclofenac sodium on the arichiodonic acid cascade. American Journal of Medicine
1986;80 (Suppl 4B):18-23.
Kraff MC, Sanders DR, McGuidan L, Raanan MG. Inhibition of blood-aqueous humour barrier breakdown with diclofenac: a fluorophotometric study. Arch Ophthalmol
Rosetti L, Bujtar E, CastoldiD, Torrazza C, Orzalesi N. Effectiveness of diclofenac eye drops in reducing inflammation and the incidence of cystoid macular edema after cataract surgery. J Cataract Refract Surg
1996;22 (Suppl l):794-99.
Italian Diclofenac Study Group: Efficacy of diclofenac eyedrops in preventing postoperative inflammation and long-term cystoid macular edema. J Cataract Refract Surg
Strelow SA, Sherwood MB, Brocato LJ, Napier A, Driebe WT, Guy JR, et al. The effect of diclofenac sodium ophthalmic solution on intraocular pressure following cataract extraction. Ophthalmic Surg
Goa LK, Chrisp P. Ocular diclofenac. A review of its pharmacology and clinical use in cataract surgery, and potential in other inflammatory ocular conditions. Drugs Aging
Polansky JR. Side-effects of topical therapy with anti-inflammatory steroids. Curr Opin Ophthalmol
Diestellhorst M, Schmidl B, Konen W, Mester U, Raj PS. Efficacy and tolerance of diclofenac sodium 0.1%, flurbiprofen 0.03%, and indomethacin 1.0% in controlling postoperative inflammation. J Cataract Refract Surg
Ronen S, Rozenman Y, Zylbermann R, Berson D. Treatment of ocular inflammation, with diclofenac sodium: Double blind study following cataract surgery. Ann Ophthalmol
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