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

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.

SUBMITTER: Cacciamani A

PROVIDER: S-EPMC7522249 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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

Cacciamani Andrea A Gelso Aldo A Di Nicola Marta M Scarinci Fabio F Ripandelli Guido G Costagliola Ciro C Rossi Tommaso T

Scientific reports 20200928 1

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 ...[more]

PMID: 32985592

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Project description:BackgroundMicroperimetric biofeedback training improved visual acuity and fixation stability in patients who previously underwent macular surgery. We aimed to compare the functional results of biofeedback training with the standard of care in patients who underwent successful inverted Internal Limiting Membrane (ILM)-flap technique for high myopic macular holes (hMMH).MethodsThis was a retrospective, comparative, cohort study. Patients with hMMH after surgical hole closure underwent microperimetric biofeedback using structured light stimulus plus acoustic tone (n = 12; Biofeedback) or standard of care with scheduled visits (n = 11; Control). Best-corrected visual acuity, retinal sensitivity at central 12° (RS) and 4° (CRS) with a mean deviation at central 12° (MD), and fixation stability as bivariate contour ellipse area (BCEA 68%, 95%, and 99%) were assessed at baseline and month 1, 3, 6, and 12. The Mann-Whitney test was used to test the difference between the groups.ResultsBaseline functional parameters were not significantly different among the groups. BCVA significantly improved in each group (Biofeedback, p = 0.002; Control, p ≤ 0.02) at all follow-up visits. CRS significantly improved at 6 (p = 0.03) and 12 (p = 0.01) months in the Biofeedback group and at month 12 (p = 0.01) in the Control group. RS (p = 0.001) and MD (p = 0.005) improved at the last follow-up only in the trained group. After training, BCEA 68% and 95% significantly improved (6 and 12 months, p < 0.05). The Biofeedback group had better results in RS (p ≤ 0.02), CRS (p ≤ 0.02), and BCEA 68%, 95%, and 99% (p ≤ 0.01) compared to the Control at all follow-ups. BCVA and MD were better in the Biofeedback group at month 3 (p = 0.01), and month 3 (p = 0.01) and 12 (p = 0.003), respectively.ConclusionsMicroperimetric biofeedback can increase retinal sensitivity and stabilize fixation better than the standard care over months after a successful inverted ILM-flap for hMMH.

Dataset Information

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

Publications

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

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