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    ‘Real-world’ ocriplasmin macular hole closure rates lag trials

     

    The members responding to the email survey reported injections in a total of 241 eyes. Their rate of release of pure vitreomacular traction was 34.1%, compared to 37.4% for the MIVI TRUST, a difference that was not statistically significant.

    The BEAVRS closure rate was 42.1% for small full-thickness holes. By comparison, the MIVI TRUST trial achieved closure rates of 58.3%, a difference that was not significant by traditional metrics (P = 0.09).

    The BEAVRS closure rate for medium sized holes was 12.7%, compared to the MIVI TRUST rate of 36.7% (P = 0.01), a difference which was considered statistically significant.

    In addition, many of the BEAVRS physicians reported serious adverse events. In 5.8% of cases, vision dropped below 6/60, including one case of only perception of light that lasted for 24 hours.

    Severe photopsia occurred in 11.6% of BEAVRS patients. Some patients described a “snow storm,” or “poorly tuned TV,” and others spoke of a “New Year’s Eve firework display.”

    The BEAVRS physicians also reported dyschromatopsia, mainly a yellowing of dimming of vision, in 6.2% of patients.

    Among the other adverse events in the BEAVRS patients:

    ·       Changes in the outer segment ellipsoid layer on optical coherence tomography (OCT): 10.4%

    ·       Among the 72% of failed cases, widening of the macular hole basal diameter on OCT: 46.9%

    ·       One case of sub-retinal fluid/lucency in a region distal to the macular hole around the optic nerve including on the nasal side of the nerve.

    ·       A rhegmatogenous retinal detachment occurred in all cases where a post ocriplasmin retinal tear occurred.

    Surgeons performed electroretinography in some cases of severe vision loss and in six cases reported marked reduction in a- and b-wave amplitudes and a loss of oscillatory potentials suggesting widespread retinal dysfunction. These changes reverted to normal after a few months.

    The BEAVRS physicians also reported zonular dialysis in four cases. Two of these occurred at the time of combined phacoemulsification, lens implant and pars plana vitrectomy surgery for macular holes that had not responded to ocriplasmin treatment.

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