The Effect of Ketorolac Tromethamine Solution 0.5% in Reducing Postoperative Inflammation after Cataract Extraction and Intraocular Lens Implantation

doi:10.1016/S0161-6420(88)33034-4

Ophthalmology

Volume 95, Issue 9, September 1988, Pages 1279-1284

https://doi.org/10.1016/S0161-6420(88)33034-4 Get rights and content

Abstract

Ketorolac tromethamine solution 0.5% (1 drop 3 times daily) was more effective than the placebo vehicle solution in suppressing postoperative anterior ocular inflammation after extracapsular cataract extraction (ECCE) and intraocular lens (IOL) implantation in this multicenter, double-masked, randomized study. Four of 60 ketorolac-treated patients compared with 25 of 58 placebo-treated patients required supplemental corticosteroid therapy to suppress inflammation in the postoperative period which was statistically significant (P < 0.001). Even though these supplemental steroid-treated patients were kept in the analysis, the placebo-treated group showed more evidence of anterior ocular inflammation as measured by anterior segment fluorophotometry. This was consistent with slit-lamp observations of increased anterior ocular inflammation. This study supported previous studies that suggested ketorolac tromethamine ophthalmic solution 0.5% was effective and safe as a nonsteroidal anti-inflammatory agent for topical use after ECCE and IOL implantation.

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There are more references available in the full text version of this article.

Cited by (65)

Effect of preemptive topical diclofenac on postoperative pain relief after photorefractive keratectomy
2011, Journal of Cataract and Refractive Surgery
Citation Excerpt :
Significant differences in antiinflammatory effects (manifested by returning flare and cells to preoperative baseline levels) were not observed when ketorolac was administered 30 minutes before surgery versus 1 day postoperatively. The authors concluded this might be the result of inappropriate timing of the preoperative dose because other studies of NSAIDs10,21,22 found additional antiinflammatory benefits when the NSAID was given 1 day and 3 days before surgery. Even with these data, additional studies of preemptive analgesia in ophthalmic surgical procedures are needed.
To assess the prophylactic effect of preoperative application of topical diclofenac on postoperative pain control in patients having photorefractive keratectomy (PRK).
Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.
Randomized masked clinical trial.
In this paired-eye study, patients having bilateral PRK received 1 drop of diclofenac 0.1% in 1 eye and 1 drop of placebo in the fellow eye 2 hours before PRK. Postoperatively, both arms of the trial (both eyes of each patient) received topical diclofenac every 6 hours for 2 days. One day and 2 days postoperatively, patients were asked to rate the perceived pain in each eye using an 11-point verbal numerical rating scale. A trained examiner noted the eye-specific responses.
All 70 patients (140 eyes) completed the study and were included in the statistical analysis. Twenty-four hours after PRK, patients reported pain scores that were clinically and statistically significantly lower in the eyes pretreated with diclofenac than in the fellow eyes (0.97 versus 2.09) (P=.018). Pain scores at 2 days did not differ significantly (P=.877).
Administration of a single drop of topical diclofenac 0.1% 2 hours before PRK seemed to increase the efficacy of postoperative pain management in a clinically and statistically significant manner.
No author has a financial or proprietary interest in any material or method mentioned.
Nonsteroidal Anti-inflammatory Drugs in Ophthalmology
2010, Survey of Ophthalmology
Citation Excerpt :
There is good evidence that topical NSAIDs reduce postoperative inflammation after cataract surgery.90–92,94,268,274 Randomized, prospective, double-masked, placebo, and active drug–controlled clinical studies with adequate numbers of patients have shown that topically applied 1% indomethacin, 0.03% flurbiprofen, 0.4% and 0.5% ketorolac, 0.1% diclofenac, 0.1% nepafenac, and 0.09% bromfenac all decrease postoperative inflammation after cataract surgery without significant toxicity when used appropriately.5,37,47,70,72,73,76,80,100,102,103,134,140,163,164,176,182,190,191,216,238,287,293,296,312,345 Only four of these drugs are FDA–approved for this use.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are increasingly employed in ophthalmology to reduce miosis and inflammation, manage scleritis, and prevent and treat cystoid macular edema associated with cataract surgery. In addition, they may decrease postoperative pain and photophobia associated with refractive surgery and may reduce the itching associated with allergic conjunctivitis. In recent years, the U.S. Food and Drug Administration has approved new topical NSAIDs, and previously approved NSAIDs have been reformulated. These additions and changes result in different pharmacokinetics and dosing intervals, which may offer therapeutic advantages. For example, therapeutic effects on diabetic retinopathy and age-related macular degeneration may now be achievable. We provide an updated review on NSAIDs and a summary of their current uses in ophthalmology with attention to potential future applications.
Bromfenac Ophthalmic Solution 0.09% (Xibrom) for Postoperative Ocular Pain and Inflammation
2007, Ophthalmology
Citation Excerpt :
In conclusion, ophthalmic NSAIDs have been shown to provide a clinical benefit before, during, and after cataract surgery to achieve several clinical objectives. Several authors have cited the utility of NSAIDs in the prevention of the development and progression of intraoperative miosis,7,8,26 postoperative inflammation,14,25 reduction of ocular pain (Seward MS, Cooke DL, Grillone LR, et al. Topical Xibrom™ 0.09% significantly reduced ocular pain following cataract surgery.
To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.09% (Xibrom) for the treatment of postoperative inflammation and reduction of ocular pain in subjects who have undergone cataract extraction (CE).
Two phase III, multicenter, randomized, double-masked, parallel, placebo-controlled clinical trials were conducted under a common protocol. Data were pooled for analyses.
Five hundred twenty-seven subjects were sequentially assigned, according to a computer-generated randomization list (2:1), to bromfenac (n = 356) or a placebo (n = 171).
Subjects who underwent cataract surgery without prior antiinflammatory treatment with a postsurgical Summed Ocular Inflammation Score (SOIS) of ≥3 were treated with either bromfenac or the placebo, instilled twice daily for 14 days in the study eye, and observed for an additional 14 days for safety evaluation.
Cleared ocular inflammation with a SOIS of 0 (cells≤5 and absence of flare after 14 days of treatment). Secondary outcomes included time to resolution of ocular inflammation, time to resolution of ocular pain, proportion of subjects with photophobia, and ocular adverse events.
Baseline characteristics were comparable between groups for age, gender, and race. The baseline mean SOIS was 3.7 in both groups. A greater proportion of bromfenac (64.0%) than placebo subjects (43.3%) achieved complete clearance of ocular inflammation at study day 15 (P<0.0001). The effect of bromfenac on clearance of ocular inflammation was as early as study day 3 after initiation of treatment, compared with the placebo (8.4% vs. 1.2%, P = 0.0012). The median time to resolution of ocular pain was 2 days (bromfenac) versus 5 days (placebo) (P<0.0001). Numbers of most ocular adverse events were lower for the bromfenac group than for the placebo group. Eye irritation was reported in a lower percentage of subjects for bromfenac (2.5%) versus placebo (4.7%), as were burning and stinging (1.4% vs. 2.5%), and photophobia (2.0% vs. 11.1%).
Bromfenac ophthalmic solution 0.09% effectively and rapidly cleared ocular inflammation and reduced ocular pain after CE. There were no serious ocular adverse events, and fewer adverse events were reported for the bromfenac group.
Congenital Corneal Anesthesia
2007, Survey of Ophthalmology
Citation Excerpt :
In addition, topical or systemic medroxyprogesterone (Provera) has shown potent anti-collagenolytic activity in experimental animal models.51,83 Topical non-steroidal anti-inflammatory drugs (NSAIDS) have been shown to reduce inflammation at least as effectively as corticosteroids following routine cataract surgery.20,33–36 The effect of NSAIDS on stromal wound repair, collagen synthesis, collagenolytic activity, and inhibition of neovascularisation has not, however, been adequately addressed.54
Congenital corneal anesthesia is a rare clinical entity that poses a diagnostic dilemma, particularly in the pediatric age group. The sensory deficit may be confined to the cornea, or extend to other divisions of the trigeminal nerve. The sensory deficit may occur as an isolated abnormality, as part of a complex neurological syndrome, or it may occur in association with multiple somatic abnormalities and congenital insensitivity to pain. This condition usually presents between the ages of 8 to 12 months. Poor vision, photophobia, conjunctival injection, and corneal ulceration in the absence of pain and distress in a child should alert the clinician to the possibility of anesthetic cornea. In the early stages of presentation, punctuate keratopathy is the main feature, which may progress to non-healing persistent corneal epithelial defects. This stage may progress to acute corneal lysis and perforation. In most patients, conservative approaches such as copious lubrication, prevention of self-harm and cautious use of bandage contact lenses are effective in preventing progressive corneal damage. Tarsorrhapy is effective in promoting epithelial healing and permanent lateral tarsorraphy may prevent further development of epithelial defects. Amniotic membrane graft may be considered in order to improve epithelial healing. Corneal grafts carry a poor prognosis. Accurate initial diagnosis, evaluation, and proper management are paramount to prevent visual loss due to long-term complications of corneal anesthesia. This review of the literature outlines the problems and approaches in diagnosis, evaluation, and management of this rare condition
Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery
2007, Journal of Cataract and Refractive Surgery
To determine whether nepafenac ophthalmic suspension 0.1% decreases the incidence and severity of inflammation and pain after cataract surgery with posterior chamber intraocular lens implantation.
Twenty-one ophthalmology clinics in the United States.
A randomized double-blind vehicle-controlled trial was conducted in which adult patients were randomly assigned to receive nepafenac 0.1% or vehicle beginning 1 day before surgery and continuing on the day of surgery (day 0) for 14 days. Patients were evaluated on days 1, 3, 7, and 14. The primary efficacy variable was the percentage of patients cured at day 14 (cure defined as aqueous cells score + aqueous flare score = 0). Other efficacy variables included percentage of patients who were pain free at all visits and aqueous cells, flare, and cells plus flare scores.
The mean age of the 476 patients (243 nepafenac, 233 vehicle) was 70 years (range 27 to 93 years). At day 14, 152 patients (62.6%) in the nepafenac group and 40 (17.2%) in the vehicle group were cured (P<.0001). A higher percentage of patients in the nepafenac group was pain free at all visits (P<.0001). Throughout the study, most nepafenac-treated patients were pain free (83.1% to 93.0%) compared with less than half the vehicle-treated patients (41.6% to 46.4%). The nepafenac group had lower mean aqueous cells, flare, and cells plus flare scores at all visits (P<.0001). No treatment-related ocular adverse events occurred in either group.
Nepafenac ophthalmic suspension 0.1% was safe and effective for preventing and treating ocular inflammation and pain associated with cataract surgery.
Antiinflammatory effect of preoperative ketorolac in phacoemulsification
2002, Journal of Cataract and Refractive Surgery
We report the antiinflammatory effect and efficacy of preoperative treatment with ketorolac in a patient with rheumatoid arthritis having phacoemulsification. This 70-year-old woman was on a maintenance dose of systemic methylprednisolone at the time of uneventful phacoemulsification in the left eye. She developed a sterile hypopyon on the first postoperative day and was treated aggressively with topical and systemic therapy, resulting in a gradual resolution of the inflammatory response. The patient subsequently had phacoemulsification in the right eye. The only significant difference in the preoperative management this time was that the patient received topical ofloxacin and ketorolac 4 days before surgery. The postoperative inflammatory response was much more controlled. The patient was continued on ketorolac and prednisolone acetate, resulting in the usual postoperative inflammatory response.

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: The authors have no commercial or proprietary interest in ketorolac ophthalmic solution 0.5% of Syntex Corporation.

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The Effect of Ketorolac Tromethamine Solution 0.5% in Reducing Postoperative Inflammation after Cataract Extraction and Intraocular Lens Implantation

Abstract

Quantitative assessment of postsurgical breakdown of the BAB following ketorolac solution 0.5%; Double-masked, paired comparison with vehicle study

Arch Ophthalmol

Quantitative assessment of postsurgical breakdown of the blood-aqueous barrier

Arch Ophthalmol