Better results, cost-effectiveness found with ILM peeling in macular hole surgery

Study finds stage 2 to 3 full-thickness macular hole cases responded well to internal limiting membrane peeling.

Issue: January 2012

Results of a large study conducted in nine centers in the United Kingdom and in Republic of Ireland support internal limiting membrane peeling as the treatment of choice for patients with stage 2 or 3 full-thickness macular holes.

FILMS (Full-thickness macular hole internal limiting membrane study) prospectively compared visual function, hole closure, complications and reoperations in two groups of patients operated for stage 2 or 3 macular hole with or without internal limiting membrane (ILM) peeling.

A total of 141 patients with idiopathic stage 2 to 3 full-thickness macular hole of less than 18 months’ duration and with visual acuity of 20/40 or less were included in the study. All patients received phaco-vitrectomy and were randomized to receive ILM peeling or no ILM peeling. They were instructed to remain in a face-down position for 5 days to 7 days postoperatively and were allowed to receive further surgery, including ILM peeling, if the macular hole did not close after the first intervention.

“Our primary outcome was distance visual acuity at 6 months. Though not statistically significant, a difference of five ETDRS letters was found in favor of the ILM peeling group. No significant difference was found in any of the secondary visual function outcomes, which included distance visual acuity at 3 months, reading visual acuity at 3 and 6 months, reading speed, and contrast sensitivity at 6 months,” Noemi Lois, MD, said at the Euretina meeting in London.

In addition, no difference in intraoperative or postoperative complications was found.

However, ILM peeling was shown to play an important role in the rate of macular hole closure.

“We found a statistically significantly higher rate of macular hole closure with a single procedure in the ILM peel group, where macular hole closure was obtained in 84% of patients in the ILM peeling group compared to 48% in the no-peeling group,” Dr. Lois said.

Results

Reoperations were significantly fewer after ILM peeling, with only eight of 67 patients (12%) having second interventions compared to 31 of 65 patients (48%) in the no-ILM peeling group.

Health-related quality of life was not significantly different, but more favorable results were found in the ILM peeling group, with a quality-adjusted life year difference of 0.002.

“We also looked at factors predicting functional and anatomical success, and we found that probably the best predictors for distance visual acuity at 6 months were distance and near visual acuity at baseline. The best predictor for hole closure at 1 month was the treatment received. The effect of ILM peeling on hole closure appeared to be equally beneficial for any size of hole, small or large,” Dr. Lois said.

Intervention costs, secondary care costs and primary care costs — ie, the entire cost of macular hole treatment — were also evaluated. Compared to no-peeling treatment, ILM peeling was found to cost £453 less on average.

“At 6 months, total costs were on average higher in the no-ILM peeling group, primarily due to the higher reoperation rate in this arm of the study. The economic evaluation suggested that ILM peeling is a cost-effective option for macular hole surgery. On average, it is likely to be less costly and more beneficial in terms of vision, anatomical closure and lower reoperation rate,” Dr. Lois said. – by Michela Cimberle

Noemi Lois, MD, can be reached at Ophthalmology Department, Grampian University Hospitals-NHS Trust, Foresterhill, Aberdeen AB25 2ZN, Scotland, U.K.; email: noemilois@aol.com.
Disclosure: Dr. Lois has no relevant financial disclosures.

Susanne Binder

As demonstrated by this study, patients suffering from macular holes stage 2 or 3 should undergo pars plana vitrectomy with internal limiting membrane peeling. This procedure might reduce the number of reoperations and the costs per patient.

The results presented in these studies are very solid and conclusive. However, a long-term follow-up might be interesting because late reopening of macular holes or pigmentary changes can occur after macular hole surgery.

— Susanne Binder, MD
OSN Europe Editorial Board Member
Disclosure: No products or companies are mentioned that would require financial disclosure.