Figures (2)  Tables (7)

    • Figure 1. 

      Study flow chart.

    • Figure 2. 

      Postoperative retinal reattachment rate.

    • Observation item Experimental group Control group
      Actual enrollment 68 (100.00%) 68 (100.00%)
      Completing the trial 61 (89.71%) 59 (86.76%)
      Without the use of device 2 (2.94%) 2 (2.94%)
      Violation of criteria 1 (1.47%) 0 (0.00%)
      Efficacy analysis population
      FAS 66 (97.06%) 66 (97.06%)
      PPS 58 (85.29%) 59 (86.76%)
      Safety analysis population
      SS 66 (97.06%) 66 (97.06%)
      FAS: full analysis set, PPS: per-protocol set, SS: safety analysis set.

      Table 1. 

      Enrolled patients and safety and efficacy analysis population.

    • Observation item Experimental group Control group Statistical approach Statistical magnitude p value
      Age (year) N (nmiss) 66 (0) 66 (0) T-test 0.289 0.773
      Mean ± SD 54.71 ± 10.56 54.17 ± 11.15
      Sex N (nmiss) 66 (0) 66 (0) Chi-square test 1.107 0.293
      Male 40 (60.61%) 34 (51.52%)
      Female 26 (39.39%) 32 (48.48%)

      Table 2. 

      The demographic data at baseline (FAS).

    • Observation item Experimental group Control group Statistical approach Statistical magnitude p value
      BCVA (LogMAR) N (nmiss) 66 (0) 64 (2) Wilcoxon −0.332 0.740
      M (Q1, Q3) 0.52 (0.22,2.00) 0.82 (0.22, 2.00)
      IOP N (nmiss) 66 (0) 66 (0) T-test −0.418 0.677
      Mean ± SD 12.74 ± 3.06 12.96 ± 3.11
      Choroidal detachment N (nmiss) 66 (0) 66 (0) Exact probability method 1.00
      No 65 (98.48%) 64 (96.97%)
      Yes 1 (1.52%) 2 (3.03%)
      BCVA: best corrected visual acuity, LogMAR: Logarithm of the Minimum Angle of Resolution, IOP: intraocular pressure.

      Table 3. 

      The studied eye characteristics at baseline (FAS).

    • Observation item Experimental group Control group Statistical approach p value
      1 d after surgery N (nmiss) 65 (1) 65 (1) Exact probability method 1.000
      Yes 64 (98.46%) 65 (100.00%)
      Not applicable 1 (1.54%) 0 (0.00%)
      14 d after surgery N (nmiss) 54 (12) 53 (13) Exact probability method 0.495
      No 0 (0.00%) 1 (1.89%)
      Yes 54 (100.00%) 52(98.11%)
      28 d after surgery N (nmiss) 51 (15) 56 (10) Exact probability method 0.620
      No 1 (1.96%) 3 (5.36%)
      Yes 50 (98.04%) 53 (94.64%)
      60 d after surgery N (nmiss) 55 (11) 56 (10) Exact probability method 1.000
      No 1 (1.82%) 1 (1.79%)
      Yes 54 (98.18%) 55 (98.21%)

      Table 4. 

      The complete retinal reattachment rates after surgery (FAS).

    • Observation item Experimental group Control group Statistical approach Statistical magnitude p value
      1 d after surgery N (nmiss) 50 (16) 49 (17) Wilcoxon 1.436 0.151
      M (Q1, Q3) 2.00 (2.00,2.00)*** 2.00 (2.00,2.00)***
      7 d after surgery N (nmiss) 59 (7) 64 (2) Wilcoxon −1.144 0.253
      M (Q1, Q3) 2.00 (0.96,2.00)*** 2.00 (2.00,2.00)***
      14 d after surgery N (nmiss) 54 (12) 52 (14) Wilcoxon −0.507 0.612
      M (Q1, Q3) 0.70 (0.30,2.00) 0.82 (0.41,2.00)
      28 d after surgery N (nmiss) 52 (14) 55 (11) Wilcoxon 0.144 0.885
      M (Q1, Q3) 0.40 (0.22,0.70)* 0.40 (0.17,0.70)***
      60 d after surgery N (nmiss) 60 (6) 56 (10) Wilcoxon −0.069 0.945
      M (Q1, Q3) 0.30 (0.10,0.52)*** 0.30 (0.10,0.52)***
      */***: Postoperative visual acuity was statistically different from preoperative visual acuity. * p < 0.05, *** p < 0.001.

      Table 5. 

      BCVA at 1, 7, 14, 28, and 60 d after surgery (FAS).

    • IOP elevation Corneal edema Cataract Anterior chamber gas
      Experimental group 17 4 8 3
      Control group 19 2 8 1

      Table 6. 

      Ocular adverse events.

    • Observation item Experimental group Control group Statistical approach Statistical magnitude p value
      AEs N (nmiss) 66 (0) 66 (0) Chi-square test 2.460 0.117
      No 36 (54.55%) 27 (40.91%)
      Yes 30 (45.45%) 39 (59.09%)
      Severity N (nmiss) 62 (0) 64 (0) Wilcoxon −0.537 0.591
      Mild 46 (74.19%) 47 (73.44%)
      Moderate 15 (24.19%) 14 (21.88%)
      Severe 1 (1.61%) 3 (4.69%)
      Relationship to the device N (nmiss) 62 (0) 64 (0) Wilcoxon −0.537 0.591
      Certainly relevant 9 (14.52%) 9 (14.06%)
      May be relevant 28 (45.16%) 23 (35.94%)
      May not be relevant 10 (16.13%) 18 (28.13%)
      Certainly not relevant 15 (24.19%) 14 (21.88%)
      Outcomes of AEs N (nmiss) 62 (0) 64 (0) Exact probability method 0.512
      Persistence 10 (16.13%) 15 (23.44%)
      Deterioration 1 (1.61%) 1 (1.56%)
      Recovery/cure 49 (79.03%) 48 (75.00%)
      Recovered but had sequelae 2 (3.23%) 0 (0.00%)
      Withdrawal due to AEs N (nmiss) 66 (0) 66 (0) Exact probability method 0.440
      Yes 5 (7.58%) 2 (3.03%)
      No 61 (92.42%) 64 (96.97%)
      AEs: adverse events.

      Table 7. 

      Occurrence of adverse events (SS).