Table 1.
Summary of real-world fluocinolone acetonide implant studies.
| Study Group | Study Design | N * (Eyes) | Follow-Up (Months) | DME † Duration (Years) | BL ‡ VA ** (Letters) | Final VA (Letters) | Final VA Gain (Letters) | Peak VA (Letters) | Peak VA Gain (Letters) | BL CRT †† (µm) | Final CRT (µm) | Final CRT Decrease (%) | Peak CRT (µm) | Peak CRT Decrease (%) | OHT at BL (%) ‡‡ | OHT (%) | OHT Meds (%) | OHT Surgery (%) | Phakic at BL (%) | Cataract (%) | Cataract Surgery (%) | Cases of Endopht (n) | Addition. ttt ††† (%) | Time Initiation Addition ttt (Months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Elaraoud et al. 2016 (all) |
Obs ‡‡‡-retro **** | 10 | 12 | NA †††† | 44.5 | 55.0 | 10.5 | 55.5 | 11.0 | 645.3 | 287.4 | −55.5 | 287.4 | −55.5 | 40.0 | NA | NA | NA | NA | NA | NA | NA | NA | NA |
| Massin et al. 2016 (prior laser + avegf ‡‡‡‡) |
Prosp ***** | 10 | 12 | 3.6 | 44.8 | 45.7 | 0.9 | 52.6 | 7.8 | 701.0 | 450.0 | −35.8 | 450.0 | −35.8 | 0.0 | 20.0 | 20.0 | 0.0 | 50.0 | NA | 20.0 | NA | 30.0 | NA |
| Massin et al. 2016 (prior laser) |
Prosp | 7 | 12 | 7.6 | 47.7 | 53.3 | 5.6 | 53.3 | 5.6 | 573.0 | 274.0 | −52.2 | 274.0 | −52.2 | 0.0 | 14.3 | 14.3 | 0.0 | 0.0 | NA | NA | NA | 14.3 | NA |
| Alfaqawi et al. 2017 (all) |
Obs-retro | 28 | 12 | 6.0 | 47.0 | 55.0 | 8.0 | 55.0 | 8.0 | 494.0 | 296.0 | −40.1 | 296.0 | −40.1 | 25.0 | 11.0 | 11.0 | 0.0 | 0.0 | 0.0 | 0.0 | 1.0 | 7.0 | 11.0 |
| El Ghrably et al. 2017 (all) |
Obs-cons | 57 | 14 | 2.6 | 52.7 | 57.8 | 5.1 | 58.3 | 5.6 | 452.0 | 326.0 | −27.9 | 326.0 | −27.9 | NA | NA | 12.3 | 0.0 | 22.8 | NA | NA | 0.0 | NA | NA |
| MEDISOFT study. 2017 (all) |
Obs-retro | 345 | 14 | NA | 51.9 | 57.2 | 5.3 | 57.2 | 5.3 | 451.2 | 355.5 | −21.2 | 355.5 | −21.2 | 14.2 | 15.4 | 13.9 | 0.3 | 10.4 | NA | NA | NA | 35.7 | . NA |
| Meireles et al. 2017 (vitrectomized) |
Obs-retro | 26 | 8.5 | 3.7 | 43.1 | 54.8 | 11.7 | 54.8 | 11.7 | 542.0 | 308.4 | −43.1 | 308.4 | −43.1 | NA | NA | 30.8 | 0.0 | 4.0 | NA | NA | NA | 11.5 | NA |
| Pessoa et al. 2017 (vitrectomized) |
Obs-retro | 24 | 24 | 2.5 | 40.5 | 57.4 | 16.9 | 57.4 | 16.9 | 543.9 | 326.3 | −40.0 | 326.3 | −40.0 | 37.5 | 4.2 | 29.2 | 0.0 | 4.2 | NA | 100.0 | NA | 8.3 | NA |
| Pessoa et al. 2017 (non-vitrectomized) |
Obs-retro | 19 | 24 | 3.5 | 42.1 | 50.3 | 8.2 | 50.3 | 8.2 | 523.6 | 368.0 | −29.7 | 368.0 | −29.7 | 31.6 | 10.5 | 52.6 | 0.0 | 36.8 | NA | 42.8 | NA | 26.3 | NA |
| RESPOND study. 2017 (all) |
Prosp | 12 | 12 | 3.4 | 48.8 | 52.5 | 3.7 | 55.6 | 6.8 | 650.5 | 357.7 | −45.0 | 357.7 | −45.0 | NA | 16.7 | NA | 0.0 | 33.0 | NA | 25.0 | NA | NA | NA |
| ICE-UK study. 2018 (all) |
Obs-retro | 233 | 12 | 2.7 | 53.0 | 55.0 | 2.0 | 58.0 | 5.0 | NA | NA | NA | NA | NA | 19.0 | 25.0 | 15.0 | 0.8 | 11.0 | NA | 73.1 | NA | 30.0 | NA |
| IRISS study. 2018 (all) |
Obs-retro | 593 | 24 | 4.5 | 51.9 | 54.8 | 2.9 | 55.6 | 3.7 | NA | NA | NA | NA | NA | NA | 19.1 | 23.3 | 0.8 | 16.4 | NA | NA | NA | 31.0 | 12.0 |
| La Mantia et al. 2018 (vitrectomized) |
Obs-retro | 7 | 12 | NA | 37.0 | 51.0 | 14.0 | 49.0 | 12.0 | 459.0 | 399.0 | −13.1 | 399.0 | −13.1 | 83.3 | NA | 0.0 | NA | 0.0 | 0.0 | 0.0 | NA | NA | NA |
| La Mantia et al. 2018 (non vitrectomized) |
Obs-retro | 16 | 12 | NA | 51.5 | 59.5 | 8.0 | 63.0 | 11.5 | 416.0 | 344.0 | −17.3 | 343.0 | −17.5 | 6.3 | NA | 18.8 | NA | 0.0 | 0.0 | 0.0 | NA | NA | NA |
| Rubiano et al. 2018 (all) |
Obs-retro | 29 | 36 | 2.6 | 43.5 | 54.5 | 11.0 | 54.5 | 11.0 | 451.0 | 314.0 | −30.4 | 314.0 | −30.4 | 6.9 | 6.9 | 6.9 | 0.0 | 3.0 | NA | NA | NA | NA | 12.0 |
| USER study. 2018 (all) |
Obs-retro | 160 | 24 | NA | NA | NA | NA | NA | NA | 370.4 | 276.6 | −25.3 | 276.6 | −25.3 | NA | 35.0 | 24.4 | 1.3 | 22.5 | NA | NA | NA | 37.0 | 14.3 |
| Coelho et al. 2019 (vitrectomized) |
Obs-retro | 8 | 24 | 3.9 | 31.5 | 49.5 | 18.0 | 50.3 | 18.8 | 594.8 | 337.8 | −43.2 | 337.8 | −43.2 | 51.7 | 12.5 | 62.5 | 0.0 | 6.9 | NA | NA | NA | 25.0 | 15.0 |
| Coney et al. 2019 (all) |
Obs-retro | 40 | 12 | 5.3 | 66.2 | 67.7 | 1.5 | 69.3 | 3.1 | 430.9 | 336.5 | −21.9 | 336.5 | −21.9 | NA | 17.5 | 12.5 | 0.0 | 22.5 | 0.0 | 0.0 | NA | 40.0 | NA |
| McCluskey et al. 2019 (all) |
Obs-retro | 18 | 18 | 2.3 | 50.7 | 56.8 | 6.1 | 56.8 | 6.1 | 444.0 | 359.0 | −19.1 | 359.0 | −19.1 | 27.8 | 16.7 | 27.8 | 0.0 | 16.7 | NA | NA | NA | 44.4 | NA |
| Vaz-Perreira et al. 2019 (all) |
Obs-retro | 44 | 24 | 3.3 | 41.9 | 50.2 | 8.3 | 55.0 | 13.1 | 542.8 | 421.4 | −22.4 | 372.0 | −31.5 | 18.2 | 25.0 | 25.0 | 2.3 | 31.8 | NA | 42.9 | NA | NA | NA |
| Young et al. 2019 (all) |
Obs-retro | 21 | 36 | 2.7 | 53.4 | 62.7 | 9.3 | 66.5 | 13.1 | 410.3 | 252.5 | −38.5 | 237.5 | −42.1 | 33.0 | 19.0 | 38.1 | 4.7 | 4.8 | NA | NA | NA | 23.8 | NA |
* Number; † Diabetic macular edema; ‡ Baseline; ** Visual acuity; †† Central retinal thickness; ‡‡ Ocular hypertension; ††† Treatment; ‡‡‡ Observational; **** Retrospective; †††† Not available; ‡‡‡‡ Anti-vascular endothelial growth factor; ***** Prospective.