Can an intracameral mydriatic combination reduce need for pupil expanders?

July 15, 2016

Intracameral administration of the fixed combination of phenylephrine and ketorolac injection 1%/0.3% (Omidria, Omeros) during cataract surgery is safe and effective for maintaining pupil dilation, and minimizes the need for a pupil expansion device, according to the findings of a retrospective study conducted by Frank A. Bucci, Jr., MD.

Reviewed by Frank A. Bucci, Jr., MD

Wilkes-Barre, PA – Intracameral administration of the fixed combination of phenylephrine and ketorolac injection 1%/0.3% (Omidria, Omeros) during cataract surgery is safe and effective for maintaining pupil dilation, and minimizes the need for a pupil expansion device, according to the findings of a retrospective study conducted by Frank A. Bucci, Jr., MD. 

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“Small pupils impede intraocular visualization and increase the risk for complications during cataract surgery,” said Dr. Bucci, founder and managing director, Bucci Laser Vision Institute, Wilkes-Barre, PA. “If adequate dilation cannot be achieved with medications alone or if there is concern about intraoperative miosis, placement of a pupil expansion device offers a potential solution.”

However, using an expansion device also adds complexity, time, and cost to the surgical procedure because there is no additional facility fee for ambulatory surgery centers or hospital outpatient departments, he said. Expansion devices also add an increased risk of bleeding, pain, and inflammation.

“The fixed combination of phenylephrine and ketorolac maintains mydriasis and preemptively blocks surgical trauma-induced release of prostaglandins to prevent miosis and reduce the need for using a pupil expansion device,” said Dr. Bucci, founder and managing director, Bucci Laser Vision Institute, Wilkes-Barre, PA, adding that this also reduces facility costs and minimizes the patient risk of intraocular injury.

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Researchers have continued to collect data on pupil expansion device use during cataract surgery, and the data are consistent with the experience of the initial study, he said. 

The retrospective review included data from 1185 consecutive cataract surgeries performed by Dr. Bucci at a single center in the months before and after he implemented the fixed combination phenylephrine/ketorolac product into his surgical protocol. The series was comprised of 668 control cases and 517 cases using the intracameral fixed combination. 

Using an expansion ring

 

Using an expansion ring

All eyes received standard preoperative treatment for cataract surgery, including topical dilating drops. In the control cases, an intracameral injection of epinephrine was selectively given in eyes at risk for intraoperative floppy iris syndrome (IFIS) or with poorly dilating pupils despite the topical drops.

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Administration of the intracameral injections (epinephrine alone in the control group and phenylephrine/ketorolac in the treatment group) was done just prior to the use of a viscoelastic, before beginning the capsulotomy. The decision of whether or not to use a pupil expansion device (Malyugin Ring, MicroSurgical Technology) was made after the delivery of any intracameral medications.

Frequency of use of the expansion ring was reduced nearly 3-fold after the protocol for pupil dilation included the fixed combination phenylephrine/ketorolac product. The device was used in 55 control cases (8.23%), but in only 14 (2.7%) of those operated on with the fixed combination phenylephrine/ketorolac product, and the difference was highly statistically significant (= 0.001)

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“The fixed combination of phenylephrine/ketorolac product is very easy to use and involves no change in the standard operating procedure-it is simply mixed into a 500 mL bottle of irrigating solution. In addition, there is no added cost for the surgeon or surgical facility when using it,” Dr. Bucci said.

Another benefit

 

“As another benefit, other studies have shown that the NSAID component of the phenylephrine/ketorolac injection helps to reduce postoperative ocular pain.”

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Dr. Bucci noted there was no significant difference between the two study groups in the percentage of cases in which a femtosecond laser was used, and that there was no bias between the groups, especially because increased prostaglandin release after treatment with the femtosecond laser could facilitate the induction of miosis.

“In general, it is likely that treatment with the fixed combination phenylephrine/ketorolac injection would be expected to be beneficial in femtosecond laser cases,” he said. “Ketorolac can offset the increase of prostaglandins and phenylephrine can offset the induction of miosis seen with femtosecond laser treatment.”

 

For more about the combination therapy, click here.

 

Frank A. Bucci, Jr., MD

E: buccivision@aol.com

This article was adapted Dr. Bucci’s presentation at the 2016 meeting of the Association for Research and Vision in Ophthalmology. Dr. Bucci is a consultant to Omeros.