Large study supports combination phaco-ECP

Las Vegas-Combined phacoemulsification with endocyclophotocoagulation (phaco-ECP) can be beneficial for patients with medically controlled glaucoma who are undergoing cataract surgery, according to long-term follow-up results, said Stanley J. Berke, MD, FACS, at the annual meeting of the American Academy of Ophthalmology.

Patients who underwent the combination procedure had significantly lower IOP with a significant reduction in medication need compared with those who had undergone phaco alone, and those benefits were achieved without any increase in early or late complications, said Dr. Berke, associate clinical professor of ophthalmology and visual sciences, Albert Einstein College of Medicine, Bronx, NY.

He reported the results from a single group practice study in which 707 patients were randomly assigned to undergo phaco-ECP (626 eyes) or phaco alone (81 eyes). Data collected during a mean follow-up of 3.2 years (range, 0.5 to 5.8 years) showed that in both surgical groups, IOP decreased initially. With extended follow-up, mean IOP, however, remained lowered from baseline in the phaco-ECP group, and average medication use was also decreased. In contrast, mean IOP increased progressively after 2 and 3 years following phaco without any change in the mean number of medications used per patient.

A paradigm shift

“We believe the statistical results of this study are sufficiently powerful to suggest a paradigm shift in our thinking about the treatment of cataract patients with concurrent glaucoma,” stated Dr. Berke, who is also chief, glaucoma service, Nassau University Medical Center, East Meadow, NY. “It is evident from the data that phaco alone does not contribute to long-term IOP control, while adding ECP to phaco does. The high safety margin of ECP in this large cohort with extended follow-up clearly indicates that this method of regulating aqueous inflow is benign. Collectively, these findings indicate [that] combining ECP with phaco should be considered in patients with cataracts and medically controlled glaucoma.”

The 707 eyes in the study were operated on by Dr. Berke and four of his colleagues from his private practice group, Ophthalmic Consultants of Long Island. The randomization ratio for allocating patients to the phaco-ECP and phaco groups was determined as appropriate by a biostatistician for meeting the investigators’ objectives of accruing a robust group of patients in the phaco-ECP arm but with a sufficient number of controls for statistical analysis, Dr. Berke explained.

All the procedures were performed using topical/intracameral anesthesia or a peribulbar block and through a clear corneal or scleral tunnel incision. Eyes undergoing ECP were treated to achieve the desired tissue effect, which was whitening and shrinking of the ciliary processes. The entire ciliary process was treated, and the treatment zone ranged from 180° to 360°.

Dr. Berke noted that his personal preference when performing ECP is to use a curved probe through a single phaco incision to achieve 270° of treatment.

“Experience with ECP suggests that the surgeon should treat a minimum of 270° to attain good IOP reduction,” he said.

All eyes in the study had one of two models of a foldable, three-piece silicone IOL implanted, and the same postoperative medication regimen, including a topical antibiotic, nonsteroidal anti-inflammatory drug, and corticosteroid, was used in all cases.

Existing IOP-lowering medications initially were maintained and then eliminated one at a time if the treating physician believed IOP reduction was adequate for the patient’s optic nerve and visual field.

In the phaco-ECP group, mean IOP was 19.08 mm Hg preoperatively, was reduced significantly to 16.03 mm Hg at 6 months, and remained at approximately that level at 1, 2, and 3 years. Among eyes that underwent only phaco, mean IOP was 18.16 mm Hg preoperatively, fell during the first year to reach 16.28 mm Hg, but had risen at 2 years and increased further to 18.93 mm Hg at 3 years.

“We believe this is the largest population ever studied that delineates the long-term natural history of phaco in the setting of medically controlled glaucoma,” noted Dr. Berke.

The mean number of medications used per patient preoperatively was 1.53 in the phaco-ECP group and 1.20 in the phaco group. At last follow-up, the mean number of medications being used was 0.65 in the phaco-ECP group and was unchanged in the controls.

Additional analyses of the medication data showed that, in the phaco-ECP group, medication use decreased in two-thirds of eyes and increased in only 5%. Medication could be decreased in only 11% of eyes in the phaco group; medication had to be added in 12%. The proportion of patients taking two or more medications was reduced from 44% preoperatively to 18% postoperatively in the phaco-ECP group and increased from 32% to 38% in the controls, Dr. Berke reported.

“We calculated [that] there were appreciable cost savings realized by the decreased need for medications after phaco-ECP of approximately $1,500 per patient per year,” he added.

Visual acuity improved in all eyes and was similar in the two study groups. No serious complications were seen in the entire population, and both groups had ~1% incidence of cystoid macular edema.

“In some eyes that had the combined procedure, the extent of postoperative inflammation was similar to that typically seen after phaco alone, although there were some cases with increased inflammation after phaco-ECP,” Dr. Berke said. “However, all of those eyes responded well to increased intensity of anti-inflammatory treatment.”OT