Wang Xia , Li Xiaoli , Wu Bin , Han Quanhong , Wang Ying
  • Tianjin Key Laboratory of Ophthalmology and Visual Science, Tianjin Eye Institute, Tianjin Eye Hospital, Clinical College of Ophthalmology, Tianjin Medical University, Tianjin 30020, China;
Wang Ying, Email: tswy77@163.com
Vitreoretinal surgery; Macular hole; 41G ultramicroneedle; Subretinal injection
10.3760/cma.j.cn511434-20240715-00267
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Objective To evaluate the efficacy and safety of 41G ultramicroneedle subretinal injection of balanced salt solution (BSS) in the treatment of large diameter macular holes (MH). Methods A prospective clinical intervention study. A total of 22 eyes of 22 large-diameter full-layer MH patients diagnosed by examination in Tianjin Eye Hospital from March to June 2024 were included in the study. Twenty-two eyes with large diameter full-thickness MH were included in the study. The minimum diameter of MH in the affected eyes was all greater than 400 μm. The affected eyes received 25G pars plana vitrectomy combined with internal limiting membrane peeling and 41G ultramicroneedle subretinal injection of BSS. The affected eyes underwent best-corrected visual acuity (BCVA), microperimetry, fundus autofluorescence, and optical coherence tomography (OCT) examinations before and 1 and 3 months after surgery. BCVA was measured using the standard logarithmic visual acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) visual acuity for statistical analysis. The minimum and base diameter of MH were measured using OCT. Microperimetry was performed using a macular integrity assessment device, recording the macular integrity index (MII) and macular threshold (MT) within 10° of the macular. The changes in BCVA, MII, MT, and the closure of MH and the occurrence of complications were compared and analyzed before and after surgery. For the comparison of the same continuous indicators before and after surgery, Student's t-test was used if the data were normally distributed and had equal variances, and the Mann-Whitney U test was used if the data were not normally distributed; the correlation between different indicators was analyzed using Pearson correlation analysis. Results Among the 22 cases (22 eyes), there were 4 males and 18 females; all were unilaterally affected. The age was 66 (60, 71) years. The duration of the disease was 5 (2.5, 12.0) months. The logMAR BCVA of the affected eyes was 1.24±0.57, and the MII and MT were 100.0 (99.53, 100.00) and 19.0 (13.23, 21.78) dB, respectively. One month after surgery, all MH were closed, with 20 (90.91%, 20/22) and 2 (9.09%, 2/22) eyes classified as typeⅠand Ⅱ closure, respectively. At the last follow-up, the logMAR BCVA was 0.62±0.58, and the MII and MT were 99.9 (59.45, 100.00) dB and 23.6 (19.33, 26.25) dB, respectively; compared with before surgery, the logMAR BCVA (t=3.579), MII (Z=－2.374), and MT (Z=－2.997) were significantly improved, and the differences were all statistically significant (P＜0.05). Correlation analysis showed that postoperative BCVA was significantly positively correlated with preoperative BCVA (r=0.41), the minimum and base diameter of MH (r=0.64, 0.58), disease duration (r=0.63), and age (r=0.50) (P＜0.05). No surgery-related complications occurred in all affected eyes during the follow-up period. Conclusion 41G ultramicroneedle subretinal injection of BSS can effectively improve the hole closure rate of large diameter MH-affected eyes in the short term, improve visual function, and has good safety.