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.
RCT Entities:
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.
Authors: C A K Lange; L Membrey; N Ahmad; L Wickham; R E Maclaren; L Solebo; W Xing; C Bunce; E Ezra; D Charteris; B Aylward; D Yorston; Z Gregor; H Zambarakji; J W Bainbridge Journal: Eye (Lond) Date: 2011-09-23 Impact factor: 3.775