Sutureless Dehydrated Amniotic Membrane (Omnigen) Application Using a Specialised Bandage Contact Lens (OmniLenz) for the Treatment of Dry Eye Disease: A 6-Month Randomised Control Trial.

For CTBD, a marginally significant difference (t = −1.827, p = 0.043) between treatments at 1 month favoured the dAM-sBCL treatment, which exhibited a 13% increase from baseline.

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The difference between treatments at 3 months was also approaching significance in favour of dAM-sBCL ( p = 0.068).

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There was a trend towards significance in temporal effect (F(2,62) = 2.7663, p = 0.070) in the dAM-sBCL treatment group (F(2,62) = 2.7663, p = 0.070), but not in the sBCL-alone group ( p = 0.740).

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Neither group showed a statistically significant treatment effect over time (repeated measures), though dAM+sBCL was close to significance (F(2,64) = 2.6348, p = 0.079, Table 2 ).

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However, the dAM+sBCL treatment group showed a trend towards significance ( p = 0.091), indicating potential benefits over time.

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In contrast, sBCL-alone treatment exhibited a negative trend (ranging from 0.8% to 9% decrease) across all nerve parameters from baseline to 1 month; sBCL-alone treatment caused a negative impact trend to CNFD with a decrease from baseline to 1 month (5.2%, t = −0.681, p = 0.526), and in CNBD with a decrease from baseline to 1 month (9%, t = 0.598, p = 0.554).

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Consequently, the response rates to the treatment for corneal staining were modest, with a marginally statistically significant 36% of participants showing improvement at one month, increasing slightly to 42% at three months.

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