Cataract surgery is one of the most common medical procedures among people’s Aged from 65 and older. In recent times, surgical techniques in cataract surgery has improved a lot and has become less traumatic to the eye. Phacoemulsification with intraocular-lens implantation is the current surgical treatment of choice for cataract extraction. Cataract surgery can be performed more easily and safely if mydriasis can lie maintained until intraocular lens implantation. Cataract surgery complications increase when miosis occurs. It was reported that, when dilatation of pupil is greater than 6mm, the incidence of posterior capsule rupture is decreased by half. During cataract surgery, maintenance of mydriasis is necessary for better visualization of the posterior chamber which facilitate proper incision of the anterior capsule, safe removal of the cataract, and implantation of intraocular lens. The most common NSAIDS used before cataract surgery are ketorolac tromethamine, diclofenac, flurbiprofen, indomethacin and nepafenac. Less affect on intraocular pressure is one of the main benefit of these medications when used for a longer period.
It is to be concluded that the efficacy of preoperative
use of Nepafenac in maintenance of intra-
operative mydriasis during cataract surgery
was found to be effective in preventing meiosis
during cataract surgery.
Nepafenac, a new salt, which is hydrolyzed by ocular tissues has proved superior intraocular penetration when compared with other anti- inflammatory drugs in both anterior segment and retinal tissue following topical ocular administration[5,6]. In 2012, a study conducted in India reported the efficacy of preoperative use of Nepafenac (85.71%) in maintenance of intraoperative mydriasis during cataract surgery. To facilitate phacoemulsification and maintain intra-operative mydriasis topical mydriatics and NSAIDS are routinely applied preoperatively. There are very scanty studies are done during last five years regarding efficacy of preoperative use of Nepafenac in maintenance of intra- operative mydriasis during cataract surgery on local as well as international level. Currently, no national data is available on the same; therefore, it is need of hour to investigate the current and local statistics of it, so that treatment of such patients should be anticipated in appropriate clinical line to prevent complications. Furthermore, result of this study will help ophthalmologist to make strategies for further research in this respect and to improve the quality of care we provide to these patients. To determine the efficacy of preoperative use of nepafenac in maintenance of intraoperative mydriasis during cataract surgery. Cataract is partial or total opacity of crystalline lens or its capsule seen on slit lamp examination and resulting in blurred vision with best corrected visual acuity (BCVA) <6/12 on Snellen chart was consider as a case of cataract surgery. Effectiveness was assessed in terms of mydriasis size. If pupillary size is maintained preoperative, intra- operative and postoperatively between 6 to 8 mm (measured through sterilized caliper) then it was label as efficacy positive
MATERIALS & AND METHODS
It was a descriptive case study conducted at Department of Ophthalmology Unit I Dow University of Health Sciences and Civil Hospital Karachi. From January 10, 2019 to July 9, 2019. By using WHO sample size calculator using efficacy of preoperative use of Nepafenac in maintenance of intra-operative mydriasis during cataract surgery (85.71%) 12, Margin of error (d)=5% and Confidence level (C.I) = 95% then the estimated sample size was n= 190 patients.
Non-probability consecutive sampling was selected.
Inclusion criteria. Patients between age group 40 -80 years of age
Exclusion Criteria. Complicated cataracts including cataracts with uveitis, pigment- dispersion / syndrome pseudo-oexfoliation, lens related glaucoma i.e. phacolytic and phacomorphic glaucoma. All diagnosed on slit lamp examination. Traumatic cataract in patient having history of trauma to eye. Diabetic patients detected on fasting blood sugar (>l20md/dl) and random blood sugar(>180md/ dl) Hypertensive by checking blood pressure (>120 systolic arid>80 diastolic), and history of cardiac disease. Data collection was started after approval of synopsis from College of Physician & Surgeons Pakistan. Patients who fulfill the inclusion criteria was included in the study. A written informed consent was taken before enrolling them into study. Nepafenac eye drops installed three times at half hour interval preoperatively and patients was operated by single consultant ophthalmologist. Pupil size was measured with a sterilized caliper at the start of surgery, after removal of lens and after implantation of intraocular lens during surgery. Post-surgery patients was followed half an hour to assess efficacy (as mention in operational definition). All the demographic data like name, age, sex, address and study variable i.e. efficacy was noted into the predesigned performa attach. The data was entered and analyzed into statistical packages for social science (SPSS Version 20). Mean ± SD was calculated for age and pupil size. Frequency and percentage was calculated for gender, and outcome variable i.e. efficacy (Yes/No). Effect modifier was controlled through stratification of age, gender and pupil size to see the effect of these on outcome followed by Chisquare test using P ≤ 0.05 as significant.
In this study 190 patients were included to assess the efficacy of preoperative use of Nepafenac in maintenance of intra-operative mydriasis during cataract surgery and the results were analyzed as Mean ± SD of age was 62.45±8.42 with C.I (61.24…63.65) years as shown in Table 1.Mean ± SD of pupil size was 8.33±1.94 with C.I (8.05…….8.60) mm as shown in Table 2.Out of 190 patients 112 (58.94%) were male while 78(41.06%) were female as shown in Fig 1. Efficacy of Nepafenac was found in 162(85.26%) patients while 28 (14.74%) patients was found to be non-effective as shown in Fig 2.
In stratification of age group (40---60) and (> 60) efficacy was noted in 108 (93.1%) and 54(73.0%) respectively and P value found to be highly significant i.e. (P=0.0001) as shown in Tab 3. In gender wise stratification nepafenac was found to effective in 101 (90.2%) male and 61 (78.2%) female and p value found to be significant i.e. (P=0.022) as shown in Tab 4. In stratification of pupil size (4.5---6) and (> 6) efficacy was noted in 50 (64.1%) and 112(100%) respectively and P value found to be highly significant i.e. (P=0.0001) as shown in Tab 5.
Miosis preoperative or intra-operative is one of the most important factor that can lead to complications during cataract surgery. Small pupil make rhexis and nucleus management difficult and leads to serious complications. Topical non-steroidal Anti-Inflammatory Drugs (NSAIDs) are important group of drugs which help cataract surgeons to reduce intra-operative miosis, and are beneficial in controlling postoperative pain and inflammation. Many comparative studies showed similar therapeutic efficacy of various ophthalmic NSAIDs with only minor differences in preventing intra-operative miosis. In the present study, the preoperative use of nepafenac demonstrated maintenance of intra- operative mydriasis during surgery and efficacy of Nepafenac was documented in 85.26% patients. One study done by Sarkar et al concluded that nepafenac is more effective in controlling miosis. Another study done by Bansal G et al concluded that there was a 6% and 5% loss of mydriasis in the nepafenac and bromfenac group which is very low, it can be due to using the drugs one day prior to the surgery whereas in this study we used the drugs on the day of surgery. A study comparing diclofenac (0.1%) and flurbiprofen (0.03%) done by Roberts concluded that both the drugs were found equally effective at maintaining mydriasis during cataract surgery. Gimbel et al concluded that flurbiprofen and indomethacin are equally effective at maintaining mydriasis during cataract surgery. In one local study Surhio et al concluded that nepafenac 0.1% preoperative is effective in maintenance of mydriasis during phacoemulsification. Cervantes-Coste et al, showed that nepafenac 0.1% compared to placebo is effective in maintaining pupillary mydriasis during cataract surgery. The total loss of mydriasis in this study was 0.78±0.56. The conclusion of this study matches with other studies that nepafenac is efficacy in maintaining mydriasis during cataract surgery. The use of topical prednisolone 1% to maintain intra-operative mydriasis was more effective than plecebo. Shaikh et al., concluded the anti-miotic use of topical prednisolone and flurbiprofen. Epinephrine is a substitute for intra-operative mydriasis maintenance. But due to sympatho-mimetic side effects (such as excessive sweating, pallor, faintness, occipital headaches, hypertension, palpitations, tachycardia, and cardiac arrhythmias, particularly in patients with pre-existing cardiac disease), it is selectively used for inhibiting intra-operative miosis.[18–21] However, concentrated solutions with bisulfite preservative included in most epinephrine preparations has caused corneal endothelial damage and corneal haze.[22,23] In one study Stewart et al., concluded that ketorolac 0.5% applied before surgery provided effective and maintained mydriasis during cataract surgery when compared with placebo. In present study Mean age of the patients was 62.45±8.42 years. Among them 112 (58.94%) were male while 78(41.06%) were female. Mean size of the pupil size was 8.33±1.94 mm. In comparison of age group (40---60) and (> 60) efficacy was noted in 108 (93.1%) and 54(73.0%) respectively and P value found to be highly significant i.e. (P=0.0001). In gender wise comparison nepafenac was found to effective in 90.2% male and 61 78.2% female and p value found to be significant i.e. (P=0.022). In stratification of pupil size (4.5---6) and (> 6) efficacy was noted 64.1% and 100% respectively and P value found to be highly significant i.e. (P=0.0001). Our results are comparable most of the national and international studies. Strength of our study was use of consecutive sampling best suited for our study design and sample selection, as our inclusion and exclusion criteria was stringent. The use of objective definitions for predictor and outcome variable also minimizes the source of bias in our study. The main limitations of our study were use of a weak study design cross-sectional the analysis and strength of evidence of which is limited and therefore the study design does not require any prior sample size calculation. Also limited outcomes selected in our study affects the worth of our study. There were many variables and factors that have association with our predictor and outcome variables that could have been included in our study. The use of non-probability sampling also limits generalized ability; however we had a small number of patients and besides the follow up duration are short. This study was hospital- based study; hence the figure does not reflect true frequency and severity of the disease. Moreover, the study was conducted in one unit in a single hospital.
It is to be concluded that the efficacy of preoperative use of Nepafenac in maintenance of intra-operative mydriasis during cataract surgery was found to be effective in preventing meiosis during cataract surgery.
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