Omidria lessens risk for intraoperative IFIS

A new grading scale measures peaks and troughs of iris billowing intraoperatively.

Patients who received Omidria during cataract surgery experienced significantly less miosis, pupil billowing and incidence of iris prolapse, all characteristics of intraoperative floppy iris syndrome.

A prospective study evaluating the effect of Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros) during cataract surgery in male patients on tamsulosin found the drug greatly reduced the risk for intraoperative floppy iris syndrome (IFIS) symptoms.

Male patients treated with tamsulosin, an alpha-1 receptor antagonist that blocks symptoms of benign prostatic hypertrophy, experience negative behavior of the iris during cataract surgery, which can lead to patients being at a greater risk for IFIS during cataract surgery, lead study author Steven M. Silverstein, MD, FACS, told Ocular Surgery News.

Steven M. Silverstein, MD, FACS
Steven M. Silverstein

“As the surgeon, I was masked to the results, so I was very pleasantly surprised to learn of the study’s outcome. Without question, there was a huge statistical significance in the reduction of all three elements or characteristics of IFIS, namely pupillary miosis, iris billowing and fluttering, and iris prolapse. Each was dramatically lessened or avoided in the eyes that received Omidria vs. eyes that did not,” he said.

The prospective case series included 50 eyes of 50 patients who underwent cataract surgery and were randomly assigned to the treatment group or control group. In the treatment group, 25 patients received 4 mL of Omidria added to 500 mL of balanced salt solution. In the control group, 25 patients received no active drug.

The researchers evaluated the differences between the groups in pupil diameter before cataract extraction, after cataract extraction and after IOL implantation, as well as the presence of iris prolapse and severity of iris billowing.

Statistically significantly more patients in the control group experienced iris billowing at least once during surgery. Iris billowing was significantly less severe in the treatment group (P < .01).

Patients in the control group had 9.33 times higher odds of developing iris prolapse than patients in the treatment group.

Age, iris color, history of diabetes and prior inflammatory diseases did not influence the results, Silverstein said.

Silverstein and colleagues created a grading scale to measure iris billowing intraoperatively.

“We created a grading scale, taking a 5-second surgical segment recorded in vivo employing an endoscope in the anterior chamber, to see if there was iris billowing and how often there was billowing, which is very dangerous during surgery for potential iris trauma. We looked to see not only how many times it occurred during the 5-second period, but also measured the peak and the trough of the billowing,” he said.

Using this grading system, Silverstein said they found significant differences between the control and treatment groups in the severity and degree of iris billowing and the occurrence of iris billowing or fluttering.

“In the control group, most patients experienced iris billowing or fluttering. A few had mild billowing, but most had moderate or severe billowing. There were no patients graded as severe in the treatment group, all objectively recorded and measured by the computer,” he said.

Silverstein said the results of the study should influence surgeons to use Omidria in all cataract and IOL implantation cases, not just for patients at the highest risk for IFIS. – by Robert Linnehan

Disclosure: Silverstein reports he is a consultant, speaker and researcher for Omeros.

Patients who received Omidria during cataract surgery experienced significantly less miosis, pupil billowing and incidence of iris prolapse, all characteristics of intraoperative floppy iris syndrome.

A prospective study evaluating the effect of Omidria (phenylephrine 1% and ketorolac 0.3% intraocular solution, Omeros) during cataract surgery in male patients on tamsulosin found the drug greatly reduced the risk for intraoperative floppy iris syndrome (IFIS) symptoms.

Male patients treated with tamsulosin, an alpha-1 receptor antagonist that blocks symptoms of benign prostatic hypertrophy, experience negative behavior of the iris during cataract surgery, which can lead to patients being at a greater risk for IFIS during cataract surgery, lead study author Steven M. Silverstein, MD, FACS, told Ocular Surgery News.

Steven M. Silverstein, MD, FACS
Steven M. Silverstein

“As the surgeon, I was masked to the results, so I was very pleasantly surprised to learn of the study’s outcome. Without question, there was a huge statistical significance in the reduction of all three elements or characteristics of IFIS, namely pupillary miosis, iris billowing and fluttering, and iris prolapse. Each was dramatically lessened or avoided in the eyes that received Omidria vs. eyes that did not,” he said.

The prospective case series included 50 eyes of 50 patients who underwent cataract surgery and were randomly assigned to the treatment group or control group. In the treatment group, 25 patients received 4 mL of Omidria added to 500 mL of balanced salt solution. In the control group, 25 patients received no active drug.

The researchers evaluated the differences between the groups in pupil diameter before cataract extraction, after cataract extraction and after IOL implantation, as well as the presence of iris prolapse and severity of iris billowing.

Statistically significantly more patients in the control group experienced iris billowing at least once during surgery. Iris billowing was significantly less severe in the treatment group (P < .01).

Patients in the control group had 9.33 times higher odds of developing iris prolapse than patients in the treatment group.

Age, iris color, history of diabetes and prior inflammatory diseases did not influence the results, Silverstein said.

Silverstein and colleagues created a grading scale to measure iris billowing intraoperatively.

“We created a grading scale, taking a 5-second surgical segment recorded in vivo employing an endoscope in the anterior chamber, to see if there was iris billowing and how often there was billowing, which is very dangerous during surgery for potential iris trauma. We looked to see not only how many times it occurred during the 5-second period, but also measured the peak and the trough of the billowing,” he said.

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Using this grading system, Silverstein said they found significant differences between the control and treatment groups in the severity and degree of iris billowing and the occurrence of iris billowing or fluttering.

“In the control group, most patients experienced iris billowing or fluttering. A few had mild billowing, but most had moderate or severe billowing. There were no patients graded as severe in the treatment group, all objectively recorded and measured by the computer,” he said.

Silverstein said the results of the study should influence surgeons to use Omidria in all cataract and IOL implantation cases, not just for patients at the highest risk for IFIS. – by Robert Linnehan

Disclosure: Silverstein reports he is a consultant, speaker and researcher for Omeros.