Pupil dilation using a standard cataract surgery regimen alone or with atropine 1.0% pretreatment

Narváez, Julio; Kronberg, Benjamin P.; Park, Hyun Woo; Zumwalt, Jonathan; Wong, Beatrice K.; Bacon, Greg; Rauser, Michael; Hoehn, A. S.; Eiseman, Heidi; Zimmerman, Grenith

doi:10.1016/j.jcrs.2009.10.049

Cited by 14 publications

(8 citation statements)

References 30 publications

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“…While the separate use of topical PE and KE has been well established in ophthalmological settings,19,20 OMS302 provides a novel method of delivering these agents to intraocular tissues throughout the surgical procedure, thereby maintaining mydriasis while pre-emptively blocking production of prostaglandin, preventing miosis, and reducing postoperative ocular pain. No change in standard operating procedure is required to use OMS302.…”

Section: Discussionmentioning

confidence: 99%

“…OMS302 contains phenylephrine hydrochloride (PE), an α1-adrenergic receptor agonist, and ketorolac tromethamine (KE), a nonselective cyclo-oxygenase 1 and 2 inhibitor. These two agents are administered topically and used independently in ILR for pupil dilation and management of ocular pain, respectively 19,20. Pharmacologically, the α1-selective agonist activity of PE mediates contraction of the radial iris dilator muscles, causing dilation of the pupil with little or no cycloplegia.…”

Section: Introductionmentioning

confidence: 99%

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Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Lindstrom¹,

Loden²,

Walters³

et al. 2014

OPTH

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BackgroundThe purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil diameter and early postoperative ocular pain when administered during intraocular lens replacement surgery.MethodsFour hundred and six patients (406 study eyes; 202 in the OMS302 group and 204 in the placebo group) were entered into this randomized, double-masked, placebo-controlled, multicenter Phase III study, which was conducted at 15 centers in the USA and the Netherlands. The patients received OMS302 (60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine) or placebo in irrigation solution during intraocular lens replacement. No other changes in procedure were required. Coprimary endpoints were change in pupil diameter over time from surgical baseline to end of procedure and patient-reported ocular pain during the first 12 hours postoperatively. Secondary endpoints included additional measures of pupil diameter and postoperative pain.ResultsOMS302 was superior to placebo in maintaining intraoperative mydriasis, preventing miosis, and reducing postoperative pain. The weighted mean (standard error) difference (OMS302 – placebo) in change in the area under the curve from baseline for pupil diameter was 0.590 ([0.049]; 95% confidence interval 0.494 to 0.686; P<0.0001). For ocular pain scores, the weighted mean (standard error) difference was −4.580 ([1.192]; 95% confidence interval −6.917 to 2.244; P=0.0002). All secondary efficacy results favored OMS302. Specifically, analyses supporting prevention of miosis (patients with ≥6 mm pupil diameter at completion of cortical clean-up and those with <6 mm diameter at any time during surgery) were significant for OMS302 (95.9% versus 77.0% and 9.2% versus 38.0%, respectively; P<0.0001 for each endpoint). OMS302 was well tolerated and not associated with any unexpected adverse events.ConclusionOMS302 maintained mydriasis, prevented miosis, and reduced early postoperative pain when administered in irrigation solution during intraocular lens replacement, with a safety profile similar to that of placebo. OMS302 is preservative-free and bisulfite-free, and its administration does not require any modification to the surgical procedure.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Lindstrom¹,

Loden²,

Walters³

et al. 2014

OPTH

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“…[1617] We have kept the critical value of pupil size as 6 mm for safe phacoemulsification. To enhance the reliability of our observations and to compensate for dropouts, we have taken a sample size of 30.…”

Section: Methodsmentioning

confidence: 99%

Phacoemulsification without preoperative topical mydriatics: Induction and sustainability of mydriasis with intracameral mydriatic solution

Gupta¹,

Kumar²,

Agarwal³

et al. 2014

Indian J Ophthalmol

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Context:Intracameral mydriatic solution can eliminate the disadvantages of repeated eye drop instillation regimen and provide adequate mydriasis for phacoemulsification with added advantages.Aims:Evaluating the role of intracameral irrigating solution (0.5% lignocaine + 0.001% epinephrine) in initiating and maintaining the pupillary mydriasis during phacoemulsification. Secondary aims were to observe the effect of surgical time, nucleus density and ultrasound time on mydriasis during the procedure.Settings and Design:The study is a prospective interventional case series, conducted at tertiary care institution.Materials and Methods:Thirty patients underwent phacoemulsification under topical anesthesia for visually significant cataract. Pupillary dilatation was achieved by intracameral irrigation of mydriatic solution alone. Pupillary diameter was measured serially during surgery and ultrasound time and total surgical time were noted.Statistical Analysis Used:Paired samples student–t test was done to compare means. Spearman correlation coefficient was used to study the effect of various parameters on mydriasis.Results:Thirty eyes completed the study. The pupil size increased from 2.1 mm (Range 2-3.5 mm SD ± 0.32) to 6.9 mm (Range 5-9 mm SD ± 1.02) in 30 seconds time after intracameral mydriatic solution delivery, and was 7.0 mm (Range 3.5 - 9 mm SD ± 0.20) at the end of surgery. Duration of surgery, grade of nucleus and ultrasound time had statistically insignificant effect on mydriasis.Conclusions:Intracameral solution containing 0.5% lignocaine and 0.001% epinephrine provides rapid mydriasis which is adequate for safe phacoemulsification and is unaffected by other parameters.

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“…Using 1% α (for avoiding false positive outcome, as good pupillary dilatation is important for safe surgery), the power calculation determined that at least 18 observations were needed to reach a 95 % power for a mean value of 7 mm (SD 1.2). (9,10) We have kept the critical value of pupil size as 6 mm for safe phacoemulsification. To enhance the reliability for our observation and to compensate for dropouts, we have taken a sample size of 30.…”

Section: Methodsmentioning

confidence: 99%

Comparison of Preoperative Topical Nepafenac (0.1%), Flurbiprofen (0.03%) and Ketorolac (0.4%) Eye Drops in Maintaining Mydriasis During Phacoemulsification- A Randomised, Double-Blind Study

Mushrif¹,

Patel²

2017

jemds

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BACKGROUND Phacoemulsification with IOL implantation is the current surgical treatment of choice for cataract extraction. Intraoperative manipulation during surgery triggers inflammatory cascade resulting in miosis, pain, inflammation or cystoid macular oedema. Adequate pupillary dilatation and its maintenance is required for proper anterior capsule incision and nucleus delivery and IOL implantation failing which may lead to complications. Aim-This study compares the effectiveness of prophylactic administration of topical flurbiprofen 0.03%, nepafenac 0.1% and ketorolac 0.4% in maintaining mydriasis during phacoemulsification with IOL implantation in the capsular bag. MATERIALS AND METHODS It is a prospective, randomised, double blind study involving 120 eyes undergoing phacoemulsification which were randomly and equally divided into four groups receiving topical nepafenac 0.1% (Group 1), flurbiprofen 0.03% (Group 2), ketorolac 0.4% (Group 3), placebo CMC 0.5% (Group 4) prior to the surgery. Pupil diameters were recorded at different stages of surgery and the mean value was compared. All the data was analysed with the software SPSS 20.0. Chi square test and ANOVA was used for comparison amongst the four groups. RESULTS Total 120 eyes were included, 50 females and 70 males of mean age 59.458 ± 8.74 years. The pupil diameter at the baseline was comparable in all four groups. Significant difference was seen in the pupil diameter in all the groups; however, nepafenac group had the least decrease in the pupil diameter at the end of surgery (P = 0.009). CONCLUSION Topical nepafenac has shown to be a potent inhibitor of miosis during phacoemulsification and also maintained the mydriasis throughout the procedure as compared to topical flurbiprofen, ketorolac and placebo.

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Pupil dilation using a standard cataract surgery regimen alone or with atropine 1.0% pretreatment

Abstract: No author has a financial or proprietary interest in any material or method mentioned.

Cited by 14 publications

References 30 publications

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Phacoemulsification without preoperative topical mydriatics: Induction and sustainability of mydriasis with intracameral mydriatic solution

Comparison of Preoperative Topical Nepafenac (0.1%), Flurbiprofen (0.03%) and Ketorolac (0.4%) Eye Drops in Maintaining Mydriasis During Phacoemulsification- A Randomised, Double-Blind Study

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Pupil dilation using a standard cataract surgery regimen alone or with atropine 1.0% pretreatment

Abstract: No author has a financial or proprietary interest in any material or method mentioned.

Cited by 14 publications

References 30 publications

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of&nbsp;intraoperative pupil diameter and reduction of&nbsp;postoperative pain in intraocular lens replacement with phacoemulsification

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of&nbsp;intraoperative pupil diameter and reduction of&nbsp;postoperative pain in intraocular lens replacement with phacoemulsification

Phacoemulsification without preoperative topical mydriatics: Induction and sustainability of mydriasis with intracameral mydriatic solution

Comparison of Preoperative Topical Nepafenac (0.1%), Flurbiprofen (0.03%) and Ketorolac (0.4%) Eye Drops in Maintaining Mydriasis During Phacoemulsification- A Randomised, Double-Blind Study

Contact Info

Product

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About

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification

Intracameral phenylephrine and ketorolac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification