Dr. Sandip Sarkar,Dr. Himangshu Das,Dr. Narayan Bardoloi
Abstract:
Purpose :
To compare the efficacy of Prednisolone Acetate(PA) &Nepafenac(N) eye drop in post operative treatment of Microincisional cataract surgery (MICS)
Setting:
Chandraprabha Eye Hospital, Jorhat, Assam, India.
Design:
Prospective,randomized,comparative,single blind sudy.
Method:
A total of 200 patients were enrolled in the study and divided into 2 groups (Group A &B). PCR, subluxation of the lens,retained cortex,iris trauma excluded . Group A received prednisolone acetate eye drops 4 times a day for 4 weeks, Group B received Nepafenac in the same dose schedule. Patients examined on 1st,7th & 30th post op days.
Results: Results were statistically analysed in chi square test and unpaired T test test.Results were statistically insignificant difference in the 2 groups in pain, lid edema, conjunctival congestion, cells, flare. Rebound inflammation was significantly higher in the steroid group (p0.002). Patients were happier in the Nepafenac group as there was no drug deposition.
Conclusion:
Nepafenac is equally effective as prednisolone acetate in suppression of inflammation and superior in patient compliance and prevention of rebound inflammation.
INTRODUCTION:
Cataract surgery is one of the most frequently performed elective surgical procedures in developed countries. The surgical methods have improved significantly over the years, thus decreasing the risk of complications and increasing patients’ and surgeons’ expectations of a successful visual outcome.1-3
One of the most common postoperative complications of phacoemulsification is anterior segment inflammation.4Intraocular inflammation causes disruption of the blood–ocular barriers and allows entry of proteins and inflammatory cells into the aqueous humor. If postoperative ocular inflammation remains uncontrolled over the long term, it can lead to various complications including cystoid macular edema (CME), corneal edema, anterior and posterior synechiae formation, and raised intraocular pressure (IOP). Recent advances in cataract surgery have resulted in a decrease in the physical trauma associated with such surgery and a subsequent decrease in the release and production of the chemical mediators that lead to postoperative ocular inflammation.5
Currently, 2 drug groups are available to control ocular inflammation: steroids and nonsteroidal anti-inflammatory drugs (NSAIDs). Steroids are potent anti-inflammatory agents that work by acting on a number of intercellular inflammatory mediators, and NSAIDs work by inhibiting the cyclooxygenase enzymes. The cyclooxygenase enzymes catalyze the formation of prostaglandins and thromboxanes. Prostaglandins mediate inflammatory reactions. Preventing the formation of prostaglandins reduces the inflammatory process.
In this comparative study, we try to evaluate the efficacy of topical corticosteroid drug Prednisolone acetate(1%) with topical NSAID drug Nepafenac (0.1%) in controlling intraocular inflammation occurring after microincisional phacoemulsification surgery .
MATERIALS AND METHOD:
This was a prospective,randomized, single blind comparative clinical interventional study conducted on 200 patient attending Chandraprabha Eye Hospital with senile cataracts requiring phacoemulsification surgery. The study period was JULY 2017- DEC 2017. The study protocol was approved by institutional ethics committee (IEC) of Chandraprabha Eye Hospital and abide by the tenets of the declaration of Helsinki. All the patients were informed about the pros and cons of the procedure and an informed consent was obtained from
All participants. All the patients who had underwent microincisional phacoemulsification surgery were randomized into 2 groups. Group A received post operatively Nepafenac0.1% (Nevanac Alcon laboratories) eye drops 4 times/ day over 4 weeks. Group B received Prednisolone Acetate 1% (Predforte Allergan India) eye drop 4 times/day in tapering doses for 4 weeks.Both groups received Moxifloxacin eye drops( Vigamox Alcon laboratories) 4 times/ day for 2 weeks.
Inclusion criteria:
- Age > 50 years
- Senile cataracts
- Uncomplicated phacoemulsification surgery.
Exclusion criteria:
- Glaucoma
- Uveitis
- Complicated cataract
- Complications during phacoemulsification like posterior capsular rupture, zonular dialysis, vitreous loss, nucleus drop, iris trauma were excluded.
All the patient underwent detailed ophthalmic examination including intraocular pressure(IOP) by applanation tonometry, fundus examination and slitlamp examination was performed. Detailed ocular and medical history was taken, routine pre-anaesthetic check-up was done. Standard surgical protocols were used in all cases. Local anesthetic (proparacaine 0.5% drops) was instilled in the conjunctival sac 3 times 5 minutes interval before surgery. A 10% povidone–iodine solution was applied to the skin around the operative site, and a 5% solution was applied to the conjunctival sac 3 min before surgery.
Under topical anesthesia, 2.2mm limbal temporal incision given. Phacoemulsification done with chopping technique in active fluidic system (CENTURIAN VISION SYSTEM ALCON LABORATORIES). A single piece acrysof foldable intraocular lens (IOL) was implanted in the capsular bag. O.5 ml of preservative free moxifloxacin( Vigamox 0.5% Alcon laboratories) was injected intracameraly. Post operatively visual acuity and detailed slit lamp examination was done. Any signs of inflammation in anterior chamber were noted. Posterior segment examination was done to assess any inflammation in vitreous and any cystoid macular oedema. Intraocular pressure (IOP) was measured with applanation tonometry.
Simple random sampling method was used for randomization. Patients in both groups were started topical antibiotic Moxifloxacin (0.5%) four times a day for four weeks. Patients were examined on day 1, day 7 and day 30 postoperatively. Visual acuity, Slit lamp examination, fundus examination and intraocular pressure was recorded on each visit.
Grading
(1) Cells in the anterior chamber (slit-lamp examination, using a 1mm slit beam):
(a) Grade 0: None.
(b) Grade 0.50: 1–5 cells.
(c) Grade 1: 5–15 cells.
(d) Grade 2: 15–25 cells
(e) Grade 3: 25–50 cells.
(f) Grade 4: >50 cells.
(2) Flare in the anterior chamber (slit-lampexamination, using a 1mm slit beam):
(a) Grade 0: None.
(b) Grade 1: Faint.
(c) Grade 2: Moderate (iris/lens details clear).
(d) Grade 3: Marked (iris/lens details hazy).
(e) Grade 4: Intense (fibrin/plastic aqueous).
(3) -Corneal edema (slit-lamp examination):
(a) Grade 0: No stromal or epithelial edema.
(b) Grade 1: Slight stromal edema.
(c) Grade 2: Diffuse stromal edema.
(d) Grade 3: Diffuse stromal edema with microcystic edema of the epithelium.
(e) Grade 4: Bullous keratopathy
Data were analyzed using the software statistical package for social science (version 20; SPSS Inc.,Chicago, Illinois, USA). Frequency distribution with its percentage and descriptive statistics with mean and SD were calculated. χ2-Test, t-test, and correlations were performed whenever needed. P values less than 0.05 were considered significant.
RESULTS:
DEMOGRAPHIC PROFILE:
| No of cases | NEPAFENAC GROUP | PREDNISOLONE GROUP |
| Sex [No of patients (%)] | 97 | 98 |
| Male | 64 (66.0%) | 58 (59.2%)
|
| Female | 33 (34.0%) | 40 (40.8%) |
| AGE (YEARS) | NEPAFENAC GROUP | PREDNISOLONE GROUP |
| MEAN | 67.92 | 69.42 |
| STD DEVITION (SD) | 7.61 | 4.84 |
| CATARACT DENSITY | NEPAFENAC GROUP | PREDNISOLONE GROUP |
| 1 and 1+ | 9 (9.3%) | 8 (8.2%) |
| 2 and 2+ | 30 (30.9%) | 27 (27.6%) |
| 3 and 3+ | 28 (28.9%) | 26 (26.5%) |
| 4 and 4+ | 30 (30.9%) | 37 (37.8%) |
| PREOPERATIVE VISION | NEPAFENAC GROUP | PREDNISOLONE GROUP |
| > 6/9 | 4 (4.12%) | 3(3.06%) |
| 6/12 | 25(25.78%) | 20(20.4%) |
| 6/18 | 8(8.25%) | 10(10.20%) |
| 6/24 | 10(10.31%) | 8(8.16%) |
| 6/36 | 50( 51.5%) | 57(58.16%) |
| TOTAL | 97 | 98 |
TABLE: COMPARISION BETWEEN TWO GROUPS IN POST OPERATIVE VISION
| POSTOPERATIVE VISION DAY1 | NEPAFENAC GROUP | PREDNISOLONE GROUP | STATISTICS |
| >6/9 | 80 (82.5%) | 82 (83.7%) | P=0.86 |
| 6/12-6/24 | 10 (10.3%) | 8 (8.2%) | Χ2= 0.31
|
| <6/24 | 7 (7.2%) | 8 (8.2%) | |
| TOTAL | 97 | 98 |
| POSTOPERATIVE VISION DAY7 | NEPAFENAC GROUP | PREDNISOLONE GROUP | P VALUE |
| >6/9 | 87 (89.7%) | 88 (89.8%) | Χ2= 0.36
p=1.00 |
| 6/12-6/24 | 7 (7.2%) | 8 (8.2%) | |
| <6/24 | 3 (3.1%) | 2 (2.0%) | |
| TOTAL | 97 | 98 |
| POSTOPERATIVE VISION DAY30 | NEPAFENAC GROUP | PREDNISOLONE GROUP | STATISTICS |
| >6/9 | 88 (90.7%) | 92 (93.9%) | P=0.56 |
| 6/12-6/24 | 6 (6.2%) | 5 (5.1%) | Χ2= 1.15
|
| <6/24 | 3 (3.1%) | 1 (1.0%) | |
| TOTAL | 97 | 98 |
TABLE: COMPARISION BETWEEN TWO GROUPS IN CORNEAL EDEMA
| NEPAFENAC | PREDNISOLONE | ||
| DAY1 | 15 (15.5%) | 15 (15.5%) | Χ2= 0.19
p=0.66 |
| DAY 7 | 7 (7.2%) | 3 (3.1%) | Χ2= 1.73
p=0.19 |
| DAY 30 | 0(0.00%) | 0(0.00%) |
TABLE: COMPARISION BETWEEN TWO GROUPS IN LID EDEMA
| NEPAFENAC | PREDNISOLONE | ||
| DAY1 | 12 (12.4%) | 12 (12.2%) | Χ2= 0.001
p=0.98 |
| DAY 7 | 2 (2.1%) | 1 (1.0%) | Χ2= 0.35
p=0.55 |
| DAY 30 | 0(0.00%) | 0(0.00%) |
TABLE: COMPARISION BETWEEN IN CONJUNCTIVAL CONGESTION
| NEPAFENAC | PREDNISOLONE | ||
| DAY1 | 16 (16.5%) | 15 (15.3%) | Χ2= 0.52
p=0.82 |
| DAY 7 | 12 (12.3%) | 9 (9.2%) | Χ2= 1.29
p=0.53 |
| DAY 30 | 0(0.00%) | 0(0.00%) |
TABLE: COMPARISION BETWEEN TWO GROUPS IN TERMS OF INFLAMMATORY PARAMETERS.
| Day1 | Day7 | Day30 | ||||
| NEPA | PRED | NEPA | PRED | NEPA | PRED | |
| AC CELLS | 0.57+.97 | 0.50+.91 | 0.04+0.20 | 0.03+ 0.17 | 0.00 | 0.00 |
| AC FLARE | 0.43+ 0.88 | 0.34+ .77 | 0.00 | 0.00 | 0.00 | 0.00 |
| IOP | 13.07+1.51 | 12.87+1.31 | 13.73+1.16 | 14.24+ 1.13 | 13.75+ 1.16 | 14.06+ 1.76 |
DISCUSSION:
Phacoemulsification with PC IOL implantation is the most common surgery performed worldwide. Some amount of intraocular inflammation is unavoidable, despite advances in surgical techniques and materials used. In our study, microincisional coaxial cataract surgery (MICS) was performed in all cases. MICS is a marvel in itself. Looks like the “ultimate” of cataract surgical progress Never before cataract surgery was under surgeon’s such exquisite control. Newer technological improvement in machine, new concept of OVDs, excellent quality IOLs have been reduce the surgical trauma to the eye.
Surgical trauma to the intraocular tissues induces the release of prostaglandins and the recruitment of neutrophils and macrophages to the site of trauma.6Many postoperative complications following the ocular inflammation have been reported, including corneal edema, increases in IOP, and CME.7,8
Our study demonstrates the safety and efficacy of nepafenac 0.1% versus prednisolone acetate 1%, as topical anti-inflammatory agents, in eyes undergoing microincisional cataract surgery.We randomized the patients into two groups andfollowed up for a period of 30 days.We assessed anterior chamber inflammation, conjunctivalcongestion, corneal edema and lid edema in boththe groups on days 1,7 30. After thirty days there was no difference noted in relation to the above-mentioned parameters of inflammation in both groups.
Studies comparing NSAIDs with corticosteroids have demonstrated no significant difference in the results between these treatments.9,10 However, NSAID treatment appears to be more effective than topical corticosteroids in re-establishing the blood–aqueous barrier.11 The beneficial effects of NSAIDs over corticosteroids include stabilization of IOP, provision of analgesia and reduction of the risk of secondary infections.12
Topical NSAIDs appear more effective than topical steroids in re-establishing the blood-aqueous barrier, as quantitatively measured with anterior ocular fluorophotometry.13 In a study by Miyake et al. nepafenac was found to be more effective than fluorometholone in preventing angiographic CME and blood aqueous barrier disruption.14 Lane et al., also, in a prospective randomized double-blinded study, showed an unequivocal reduction in post cataract surgery pain and inflammation in patients receiving topical nepafenac.15
Two groups were almost similar in age and gender distribution. The average best corrected visual acuity (BCVA) was 6/9 in both the groups. Hence no significant difference was present in both groups regarding final visual outcome after cataract surgery. As per our study no patient on topical Prednisolone acetate had persistent post-operative inflammation after 1 month. However, the difference was not statistically significant. 6 patients in prednisolone group showed rebound inflammation but no patient showed such symptoms in Nepafenac group. Total 5 patients were lost to follow up.
CONCLUSION:
Nepafenac & prednisolone eye drops are equally efficacious in controlling post operative inflammation following MICS. Nepafenac is superior to Prednisolone acetate in terms of not producing rebound inflammation.Patients find Nepafenac more comfortable as unlike prednisolone acetate it does not leave depositions in the eye
REFERENCES:
- 1.Gulkilik G, Kocabora S, Taskapili M, Engin G. Cystoid macular edema after phacoemulsification: risk factors and effect on visual acuity. Can J Ophthalmol 2006; 41:699–703.
- 2. Saif MYS, Abdel Khalek MO, Saif ATS, Saif PS, Safina SK. Predictability and accuracy of IOL formulas in high myopia. J Emmetropia 2016; 1: 17–21.
- 3.Saif MYS, Saif ATS, Saif PS, Abdel Khalek MO, Mahran W. Dry eyechanges after phacoemulsification and manual small incision cataract surgery (MSICS). Int J Ophthalmol Eye Res 2016; 4:184–191.
- 4.Carrasquillo AM, Goldstein DA. Postoperative uveitis. In: Tasman W, Jaeger EA, eds, Duane Clinical Ophthalmology. Philadelphia, PA, Lippincott-Raven, 2004; vol. 4; chapt 55
- 5.Solomon KD, Cheetham JK, DeGryse R, Brint SF, Rosenthal A. Topical ketorolac tromethamine 0.5% ophthalmic solution in ocular inflammation after cataract surgery. Ophthalmology 2001; 108:331–337.
- 6.Ursell PG, Spalton DJ, Whitcup SM, Nussenblatt RB. Cystoid macular edema after phacoemulsification: relationship to blood-aqueous barrier damage and visual acuity. J Cataract Refract Surg 1999; 25:1492–1497.
- 7.Bélair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol 2009; 148:128–135.
- 8.El-Harazi SM, Feldman RM. Control of intra-ocular inflammation associated with cataract surgery. Curr Opin Ophthalmol 2001; 12:4–8.
- 9.Roberts CW, Brennan KM. A comparison of topical dicolfenac with prednisolone for post-cataract inflammation. Arch Ophthal. 1995;113:725–727.
- 10.El-Harazi SM, Ruiz RS, Feldman RM, et al. A randomized double-masked trial comparing ketorolac tromethamine 0.5%, diclofenac sodium 0.1%, and prednisolone acetate 1% in reducing post-phacoemulsification flare and cells. Ophthalmic Surg Lasers. 1998;29:539–544.
- 11.Wolf EJ, Braunstein A, Shih C, Braunstein RE. Incidence of visually significant pseudophakic macular edema after uneventful phacoemulsification in patients treated with nepafenac. J Cataract Refract Surg. 2007 Sep; 33(9):1546–1549.
- 12.Hsu JK, Johnston WT, Read RW, et al. Histopathology of corneal melting associated with diclofenac use after refractive surgery. J Cataract Refract Surg. 2003;29:250–256.
- 13.Jampol LM, Jain S, Pudzisz B, Weinreb RN. Non-steroidal anti-infl ammatory drugs and cataract surgery. Arch Ophthalmol 1994;112:891-4.
- 14.Miyake K, Ota I, Miyake G, Numaga J. Nepafenac 0.1% versus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. J Cataract Refract Surg 2011;37:1581-8.
- 15.Lane SS, Modi SS, Lehmann RP, Holland EJ. Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular infl ammation associated with cataract surgery. J Cataract Refract Surg 2007;33:53-8.
Leave a Comment