Inverted ILM-flap techniques variants for macular hole surgery: randomized clinical trial to compare retinal sensitivity and fixation stability

Andrea Cacciamani, Aldo Gelso, Marta Di Nicola, Fabio Scarinci, Guido Ripandelli, Ciro Costagliola, Tommaso Rossi, Andrea Cacciamani, Aldo Gelso, Marta Di Nicola, Fabio Scarinci, Guido Ripandelli, Ciro Costagliola, Tommaso Rossi

Abstract

To report closure rate, Best Corrected Visual Acuity (BCVA), Retinal Sensitivity (RS) and Fixation Stability (FS) of idiopathic Macular Holes (MH) randomized to Cover Group (CG) or Fill Group (FG) of the Inverted Internal Limiting Membrane (ILM) flap surgical procedure. Twenty-eight patients were randomized (1:1) to receive a vitrectomy with either Cover or Fill ILM flap technique. All patients underwent BCVA, RS and FS assessment at baseline, 1-month and 3-months after surgery. MH closed in all patients. BCVA rose from 20/100 (baseline) to 20/33 (1-month) in both groups, to 20/28 in CG versus 20/33 in FG (3-months) (p < 0.05). The central 4° RS rose from 11.5 and 12 dB to 19 and 19.5 dB (1-month) and to 22 and 20 dB (3-months), respectively, in CG and FG (p < 0.001). The central 10° RS rose from 11 and 15 dB to 22 and 20 dB (1-month) and to 23 and 20 dB (3-months), respectively, in CG and FG (p < 0.001). FS increased significantly more in CG. CG improved significantly more than FG in terms of BCVA, RS and FS. The average MH diameter was relatively small (397 µm); larger MHs may behave differently.Trial registration: Trial Registry: https://www.clinicaltrials.gov ; Identifier: NCT04135638. Registration date 22/10/2019.

Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Best corrected visual acuity trend of cover and fill groups at baseline, 1-month and 3-months follow-up. The difference at 3-month follow-up is statistically significant (p < 0.001). (GIMP free software, version number GIMP 2.10.18, released 2020-02-24, URL https://www.gimp.org).
Figure 2
Figure 2
Retinal Sensitivity within the central 4° and 10° trend of Cover and Fill Groups at baseline, 1-month and 3-months follow-up. The difference at 3-month follow-up is statistically significant (p < 0.001) (GIMP free software, version number GIMP 2.10.18, released 2020-02-24, URL https://www.gimp.org).
Figure 3
Figure 3
Scattergram showing Macular Hole diameter versus IS/OS line defect width. (GIMP free software, version number GIMP 2.10.18, released 2020-02-24, URL https://www.gimp.org).

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