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Two-Year Results of a Randomized Clinical Trial Comparing Natural History, Vitrectomy, and Vitrectomy Plus Autologous Serum: Moorfields Macular Hole Study Group Report No. 1

Eric Ezra, MD, FRCS, FRCOphth; Zdenek J. Gregor, FRCS, FRCOphth; for the Moorfields Macular Hole Study Group

Arch Ophthalmol. 2004;122:224-236.

Objectives  To determine the benefits of idiopathic full-thickness macular hole (FTMH) surgery compared with observation and to evaluate the use of autologous serum as an intraoperative adjunct.

Methods  A randomized clinical trial was performed to evaluate the anatomic and visual benefits of FTMH surgery for lesions of 9 months or less symptom duration and visual acuity of 20/60 or less. We compared surgery with natural history and determined whether use of intraoperative adjunctive autologous serum improves the surgical outcome. Eyes were randomized to (1) observation, (2) vitrectomy, or (3) vitrectomy plus serum and were followed for 24 months to assess anatomic status and visual function.

Results  In total, 185 eyes of 174 patients were enrolled. In the observation group, spontaneous closure of the FTMH occurred in 7 (11.5%) of 61 patients, with little or no change in overall acuity levels in 24 months. In contrast, the surgical groups had an overall closure rate of 80.6% (100/124) at 24 months, with 45% of eyes achieving Snellen acuity of 20/40 or greater. Surgical eyes had better median near acuity than observation eyes by 6 lines (N5 vs N14). Use of autologous serum did not seem to affect anatomic or visual results. At 24 months, 72 (58.1%) of 124 surgical eyes had undergone cataract extraction.

Conclusions  Surgery for FTMH is safe and effective and is associated with significant visual improvement compared with the natural history. Autologous serum application does not enhance the results of surgery.

From the Vitreoretinal Service, Moorfields Eye Hospital, London, England. A complete list of the members of the Moorfields Macular Hole Study Group appears below. The authors have no relevant financial interest in this article.

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