A Comparative Study of Prednisolone Acetate 1% V/Sketorolac

ORIGINAL ARTICLE

A COMPARATIVE STUDY OF PREDNISOLONE ACETATE 1% V/SKETOROLAC TROMETHAMINE0.4%OPHTHALMICSOLUTIONSINTHEMANAGEMENTOF OCULARINFLAMMATIONANDPAINFOLLOWINGPHACOEMULSIFICATION CATARACTSURGERY

Dileep Kumar1, Dayachand Gupta2, Indu Arora3, Anil Goyal4, Chetanya P. Gupta5, Pooja Agrawal6, Bhumika Khetan7, Neelam Chaudhary8

HOW TO CITE THIS ARTICLE:

Dileep Kumar, Dayachand Gupta, Indu Arora, Anil Goyal, Chetanya P. Gupta, Pooja Agrawal, Bhumika Khetan, Neelam Chaudhary. “AComparativeStudy ofPrednisoloneAcetate1%V/SKetorolac Tromethamine0.4%OphthalmicSolutions. InTheManagement of OcularInflammationAndPainFollowingPhacoemulsification CataractSurgery”. Journal of Evolution of Medical And Dental Sciences 2013; Vol2, Issue 51, December 23; Page: 10014-10019.

ABSTRACT: Purpose: A comparativestudyofprednisoloneacetate1%v/sketorolac tromethamine0.4%ophthalmicsolutionsinthemanagementof ocularinflammationandpainfollowingphacoemulsification cataractsurgery. SETTING:Ophthalmology Department, Mahatma Gangdhi Medical College &hospital,sitapura,jaipur. METHOD:We have taken 50 patients age 40 years or more, both male & female with senile cataract attending our eye OPD of Mahatma Gandhi Medical Collage & Hospital.All patients having uneventful phacoemulsification with PCIOL surgery under local anesthesia, divided in two groups (A=25 and B=25) randomly. Post-operative group A patients receive ketorolac tromethamine 4% eye drop and group B receive 1% prednisolone acetate for ophthaimic solution as anti inflammatory along with other drugs. After surgery follow up was done on day 1,7,14,&28 During each follow up visit operated eye was examined for ocular pain, slit examination of anterior segment, uncorrected visual acuity and for IOP at day- 7,14,28.RESULT: The study used 50 eyes, 25 in each group A & B. In controlling of post operative inflammation upto day 7, group B had slight better result than group A which was statistically significant.CONCLUSION: Both drugs ketorolac & prednisolone are efficient in controlling the inflammation after cataract surgery. But efficacy of prednisolone is more than ketrolac.FINANCIALDISCLOSURE:No author has a financial or property interest in any material or method mentioned.

INTRODUCTION: Postoperative Ocular inflammation is a natural sequel following cataract surgery. Cataract surgery is an invasive procedure that requires incision and cutting of ocular tissue as well as considerable intraocular tissue manipulation.It presents as ocular pain, swelling and redness for as long as 4-6 weeks after surgery. Anti-inflammatory Drugs are used to subsides these reaction. Inflammation after cataract or other ophthalmic surgery begins with tissue injury when the surgical incision is made. This incision triggers the inflammatory cascade, which begins with activation of phospholipase A-2. Phospholipids in the cell membranes are broken down into arachidonic acid, which is then converted to prostaglandins by cyclooxygenase or converted to hydroxy acids and leukotrienes by 5-lipoxygenase.1,2 Current treatment options available [both topical corticosteroids and topical ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) ]aim to reduce prostaglandin (PG) production through inhibition of steps in the arachidonic cycle.3AIMS AND OBJECTIVE: To compare the efficacy and safely of prednisolone acetate 1% v/s ketorolac tromethamine 0.4% ophthalmic solution in controlling ocular inflammation and pain following cataract surgery by phacoemulsifaction.

MATERIAL AND METHOD: We have taken 50 patients age 40 years or more, both male & female with senile cataract attending our eye OPD of Mahatma Gandhi Medical Collage & Hospital. Our Case exclusion criteria was previous intraocular surgery, Previously healed ocular inflammation, One eyed patients, Intraocular pressure (IOP)> 24 mmHg., Pseudoexfoliation, Patients who developed intra-operative complications, Patients with uveitis.

All patients having uneventful phacoemulsification with PCIOL surgery under local anesthesia, divided in two groups (A=25 and B=25) randomly. Post-operative group A patients received ketorolac tromethamine 4% eye drop and group B received 1% prednisolone acetate ophthalmic solution as anti-inflammatory along with other drugs. After surgery follow up was done on day 1,7,14,&28 During each follow up visit operated eye was examined for ocular pain, slit examination of anterior segment, uncorrected visual acuity and for IOP at day- 7,14,&28.

RESULT: On 1st post of operative day (Table 1 and 2) 72% case of group and 68% of group B experienced mild to moderate pain. 7 patients in group A and8 Patients in group B were free from pain on 1st post op day. On 7th day in Group A and 3 Patient in group B had mild pain although 20 patients in groupA and 22 in group B were free from pain. In table 3 & 4 on 1st post op day 60% patients had mild, 70 had moderate corneal edema from both groups. On 7th post op day both groups had same result. In table 5 mean IOP ofpre-operative and post-operative patients of both group was almost same. In table 6&7 none at patient had severe keratitisin both group on 7th post-Opday but 64% patients had mild to moderate keratitis in both group on 7th day. Mild keratitis was present in 8% patients of group A & 4% of group B. In table 8&9, mild to moderate hare was present in 76% patients of both group on 1st post op day. On 7th post-op day, 16% of group A and 12% of group B patients had mild hare.

DISCUSSION: Although both the drugs have antimflammtory action, prednisolone is stronger than ketorolac.Steroids and NSAIDs intervene at different steps of the inflammatory cascade: steroids act upstream on phospholipase A-2 to stop the breakdown of phospholipids, while NSAIDs act downstream on cyclooxygenase to inhibit the conversion of arachidonic acid to prostaglandins.4

Ophthalmic NSAIDs currently play four principal roles in Ophthalmic surgery, including the prevention of intra operative miosis during cataract surgery, management of postoperative inflammation, the reduction of pain and discomfort after cataract surgery and prevention and treatment of CME after cataract surgery.5 NSAIDstreatment appears to be more effective than corticosteroids in re-establishing the blood aqueous barrier.6 The beneficial effects of NSAIDs over corticosteroidsinclude stabilization ofIOP, provision of analgesia, reduction of risk of secondary infections, no delayed wound healing.7 Samevial of NSAIDs can be used both preoperatively as well as postoperatively, so it is economicalalso to the patients. In our result for controlof pain, corneal edema, keratitis and flare, prednisolone is slightly better than ketorolac at 7th post-operative phacoemulsification surgery day. At 14th post-operative day both drugs are equally efficient to control all reaction and visual acuity was almost same in both group at 42nd post op day.

CONCLUSSION: Both drugs ketorolac & prednisolone are efficient in controlling the inflammation after cataract surgery. But efficacy of prednisolone is more than ketrolac.

BIBLIOGRAPHY:

El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. CurrOpinOphthalmol. 2001 Feb;12(1):4-8.
Roberts CW, Pretreatment with topical diclofenac sodium to decrease postoperative inflammation, Ophthalmology, 1996;103:636–9.
Negi AK, Browning AC, Vernon SA. Single perioperative triamcinolone injection versus standard postoperative steroid drops after uneventful phacoemulsification surgery: randomized controlled trial. J Cataract Refract Surg. 2006;32(3):468–474.
Srinivasan BD, Kulkarni PS. The role of arachidonic acid metabolites in the mediation of the polymorphonuclear leukocyte response following corneal injury. Invest Ophthalmol Vis Sci. 1980;19:1087–1093.
Heier JS, Topping TM, Baumann W, et al.Ketorolac versusprednisolone versus combination therapy in treatment of acute pseudophakic cystoid macular edema. Ophthalmology 2000;107: 2034–8.
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Post-operative day / Severity of Pain / Total No. of cases
1 / X2 = 16.76
P = .00079 / Nil / Mild / Moderate / Severe
7 / 14 / 4 / 0 / 25
7 / X2 = 43
P = 0 / 20 / 5 / 0 / 0 / 25
14 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 1: Grades of pain during follow ups of cases of group A (ketroloc)
Post-operative day / Severity of Pain / Total No. of cases
1 / X2 = 21.88
P = .00006 / Nil / Mild / Moderate / Severe
8 / 15 / 2 / 0 / 25
7 / X2 = 53
P = 0 / 22 / 3 / 0 / 0 / 25
14 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 2: Grades of pain during follow ups of cases of group B (Prednisolone)
Post-operative day / Severity of Corneal Edema / Total No. of cases
1 / X2 = 15.48
P = .0014 / Nil / Mild / Moderate e / Severe
10 / 12 / 3 / 0 / 25
7 / X2 = 75
P = .0 / 22 / 3 / 0 / 0 / 25
14 / 24 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 3: Grades of Cornel Edema observed by Slit-lamp
Biocroscopy during follow ups of cases of group A (Ketroloc)
Post-operative day / Severity of Corneal Edema / Total No. of cases
1 / X2 = 18.65
P = .0003 / Nil / Mild / Moderate e / Severe
10 / 12 / 3 / 0 / 25
7 / X2 = 53
P = 0 / 22 / 3 / 0 / 0 / 25
14 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 4: Grades of Cornel Edema observed by Slit-lamp
Biocroscopy during follow ups of cases of group B (Prednisolone)
Group A (Ketorolac) / Group B (Prednisolone)
Mean IOP / SD / Mean IOP / SD
Pre- operatively / 16.25 / 1.7253 / 16.4 / 1.3844
Post- operatively / 16.12 / 1.05357 / 16.44 / 1.175
p = .7486
t = .3223 / p = .912
t = .1108
TABLE 5: Change in Intraocular Pressure (IOP) recorded on 28thpost operative
day in both group[in both group A (Ketroloc) and group B (Prednisolone)]
Post-operative day / Severity of Striate Keratitis / Total No. of cases
1 / X2 = 11.32
P = .0101 / Nil / Mild / Moderate e / Severe
9 / 11 / 5 / 0 / 25
7 / X2 = 60.00
P = 0 / 23 / 2 / 0 / 0 / 25
14 / 0 / 25 / 0 / 0 / 0
28 / 0 / 25 / 0 / 0 / 0
TABLE 6: Grades of Keratitis based on Slit-lamp Biomicroscopy
during follow ups of cases group A (Ketroloc)
Post-operative day / Severity of Striate Prednisolone / Total No. of cases
X2 = 13.56
P = .003 / Nil / Mild / Moderate e / Severe
9 / 12 / 4 / 0 / 25
X2 = 75
P = 0 / 24 / 1 / 0 / 0 / 25
19 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 7: Grades of Striate Keratitis based on Slit-lamp
biomicroscopy during follow ups of cases group B (Prednisolone)
Post-operative day / Severity of Aqueous Flare / Total No. of cases
1 / X2 = 10.36
P = .01 / 0
Nil / 1+
Mild / 2+
Moderate e / 3+
Severe
6 / 11 / 8 / 0 / 25
7 / X2 = 48
P = 0 / 21 / 4 / 0 / 0 / 25
19 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 8: Grades of aqueous flare based on Slit-lamp
biomicroscopy during follow ups of cases of group A (Ketroloc)
Post-operative day / Severity of Aqueous Flare / Total No. of cases
1 / X2 = 11.64
P = .008 / 0
Nil / 1+
Mild / 2+
Moderate e / 3+
Severe
6 / 12 / 7 / 0 / 25
7 / X2 = 53
P = 0 / 22 / 3 / 0 / 0 / 25
19 / 25 / 0 / 0 / 0
28 / 25 / 0 / 0 / 0
TABLE 9: Grades of aqueous flare based on Slit-lamp
biomicroscopy during follow ups of cases of group B (Prednisolone)
Best corrected visual acuity
(BCVA)
(Day 42)c / Group A
(ketorolac) / Group A
(Prednisolone)
No. of cases / No. of cases
6/6-6/6P / X2 =0.72
P =0.39 / 18 / 19
6/9-6/12 / X2 =0.72
P =0.39 / 6 / 5
6/18-6/24 / 1 / 1
6/36-6/60 / 0 / 0
r2 =18.32
P = .00001 / r2 =21.44
P = .00002
TABLE 10: Distribution of cases according to best corrected visual acuity (BCA A) recordedon 42ndpost operative day [in both group A (NSAIDS, n = 25) and group B (Steroid, n = 25)]

Journal of Evolution of Medical and Dental Sciences/Volume 2/Issue 51/ December 23, 2013 Page 1