research digest

Study Shows Phaco/ECP Procedure Helps Reduce Long-Term Need for Medication in Glaucoma

A 707-eye study presented at the American Glaucoma Society in March 2006 showed that when endoscopic cyclophotocoagulation (ECP) was used simultaneously with phacoemulsification for patients with cataracts and medically controlled glaucoma, patients required fewer long-term glaucoma medications to maintain desirable IOP levels. Stanley Berke, M.D., and colleagues performed phaco/ECP on 626 eyes and compared the results to 81 eyes receiving phaco alone over a period of 5 years. The patients who received the combination treatment underwent phaco and 200Þ to 270Þ ECP and all patients were followed for 6 months to 5 years (mean 31.2 months). The goal of the treatment in this study was long-term reduction and stability of IOP, resulting in fewer medications required over time.

The patients who received combined phaco/ECP achieved a statistically significant IOP reduction after surgery (19.08 mm Hg preop [±4.14], 15.73 mm Hg postop [±3], P=.0001), while the phaco alone group did not (18.6 mm Hg preop [±3.38], 18.93 mm Hg postop [±4.12], P=.60). After surgery, the combination phaco/ECP patients also required significantly fewer medications to maintain the lower IOP levels (1.53 medications preop [±0.89], 0.65 medications postop [±0.95], P=.0001). The reduction in required medications to control IOP was not significant for the patients who had phaco alone (1.20 medications preop [±0.83], 1.20 medications postop [±0.87], P=.5).

Over long-term follow-up, 68% of patients who underwent combined phaco/ECP required at least one less medication to control IOP postoperatively, while only 11% of the patients who had phaco alone enjoyed this benefit. Importantly, no increased risk for serious complications or cystoid macular edema was found in the long-term follow-up for patients undergoing phaco and ECP.

"There are a lot of patients who would potentially benefit from a combined phaco/ECP procedure," Dr. Berke says. "Traditionally, the only choice for patients with cataracts and glaucoma was phaco alone or phaco/trabeculectomy. That's a big leap because there's a lot of difference between these in terms of results, complexity and postoperative concerns. I like having this third choice of phaco/ECP for patients with moderate glaucoma."

Dr. Berke also says that patients in the study experienced no complications related to the ECP procedure, indicating its safety.

Bromfenac Twice Daily Shown Effective for the Treatment of Acute Pseudophakic CME

A 52-eye study, presented in a poster at the 2006 Association for Research in Vision and Ophthalmology (ARVO) meeting, showed that fewer doses of bromfenac 0.09% (Xibrom, Ista Pharmaceuticals) were as effective as more frequent dosing with diclofenac 0.1% (Voltaren, Merck) and ketorolac 0.5% (Acular, Allergan) when treating acute pseudophakic cystoid macular edema (CME).

David S. Rho, M.D., and colleagues randomized patients who had been diagnosed with acute pseudophakic CME after cataract surgery to treatment with one drop b.i.d. of bromfenac (18 patients) and one drop q.i.d. with either diclofenac (18 patients) or ketorolac (16 patients) for
3 months. All patients were examined and tested monthly using ETDRS charts. After 3 months, all patients achieved statistically significant gains in letters on the ETDRS chart (bromfenac: mean gain of 11.8 ±8.1 letters; diclofenac: mean gain of 11.5
±7.3 letters; ketorolac: mean gain of 10.6 ±8.1 letters), but the differences between the three groups were not significant.

"The reported clinical findings demonstrate that Xibrom's enhanced potency and penetration lead to equivalent results with fewer applications each day, which may translate into a real benefit to patients from the financial and convenience perspectives," says Lisa R. Grillone, Ph.D., vice president of Clinical Research at ISTA. "Other studies have shown that reducing the number of daily doses greatly increases treatment compliance with ophthalmic medications. We believe that improving compliance in this way can have a direct impact on clinical outcomes, particularly for treatments lasting several months or involving several different medications."

Epithelial Healing Rates Faster, Pain Lower for Ketorolac 0.4% After Surface Ablation than Nepafenac 0.1%

A study scheduled to enroll 60 eyes that were randomized to receive either ketorolac 0.4% (Acular LS, Allergan) or nepafenac 0.1% (Nevanac, Alcon) after surface ablation showed that healing rates and pain scores were more favorable with ketorolac 0.4%.

Marguerite B. MacDonald, M.D., and William Trattler, M.D., presented the data during the 2006 ARVO meeting. Patients were given drops of either NSAID immediately postoperatively on the stromal bed prior to bandage contact lens placement, and continued therapy t.i.d. for 5 days.

Follow-up was at 1 and 5 days postop, along with phone follow-up for pain evaluation at 5 hours postop, and days 2, 3 and 4. The measures used to determine outcomes included a pain questionnaire and slit lamp exams to monitor healing rates.

The difference in pain reported at day 3 (postop day 2) was significant, with a pain score of 0.71 (out of 10) for ketorolac 0.4% vs. a pain score of 1.86 (out of 10) with nepafenac 0.1% (P=.046).

During the study, eyes that received nepafenac had a delay in epithelial healing of 2.2 days compared with eyes that received ketorolac (P=.066). Additionally, the degree of corneal haze was significantly more severe with nepafenac 0.1% at 1 week and 1 month postop (P<.039).

Because of the severe delays in epithelial healing and the high rate of haze in eyes that received nepafenac, the study was halted after only 14 eyes for safety reasons.

"Since ketorolac 0.4% was shown in Kerry Solomon's study (J Cataract Refract Surg. 2004;30:1653-1660) to provide a significant reduction in pain following PRK without a significant delay in epithelial healing, I assumed that we could administer all topical NSAIDs in the same manner directly on the stromal bed prior to bandage contact lens placement," says Dr. Trattler. "However, our findings revealed that if nepafenac 0.1% is used in this way, significant delays in epithelial healing and early corneal haze are likely to develop."