Abstract
Purpose :
Neurotrophic keratopathy (NK) is a neurodegenerative corneal disease. Cenegermin 0.002% is currently the only FDA-approved drug to treat NK. Studies have shown improvement in corneal healing. However, nerve regeneration and improvement in corneal sensation have not been well established. Thus, we aim to assess the effect of cenegermin 0.002% treatment on corneal nerve regeneration using corneal in vivo confocal microscopy (IVCM) and on corneal sensation using Cochet-Bonnet in patients with neurotrophic keratopathy (NK).
Methods :
This is a retrospective study that identified patients seen at New England Eye Center from 1/1/2015 to 3/31/2022 with an ICD10 code for NK (H16.23X) or the keyword “neurotrophic” in their chart. NK was diagnosed based on decreased corneal sensation and findings on slit-lamp. Included subjects must have completed at least 4 weeks of cenegermin treatment and have a pre- and post-treatment IVCM on file. Corneal sensation was recorded if documented. For each visit, 3 representative IVCM images were selected and graded in a masked fashion for total, main, and branch nerve density using ImageJ/NeuronJ and compared to controls from a reference database. Unpaired tests were used to compare the NK group and healthy controls. Paired comparisons were used to analyze pre- and post-treatment nerve density values.
Results :
The NK (n=25; age:64.2±2.8yrs; 28% male) and age- and sex-matched control groups (n=20; age:58.4±8.8yrs; 40% male) did not differ in age (p=0.1) or sex (p=0.72). Data included subjects with Stage 1(88%), 2(8%), and 3(4%).Total, main, and branch densities [median (range) in µm/mm2] were lower in the NK group pre-treatment [2,301.0 (0-17,111.1); 1,653.5 (0-11,409.7); 547.9 (0-10,175.9); respectively] vs. controls [22,253.7 (14,942.2-28,991.9), (p<0.001); 10,130.95 (3,219.1-15,382.5) (p<0.001); and 12,080.9 (6,910.0-18,417.1), (p<0.001), respectively]. Post-treatment, total, main, and branch nerve densities increased to 5,306.7 µm/mm2 (0–19,403.1; p=0.004), 3,452.0 (0-13,227.1; p=0.005), and 1,987.9 (0-10,424.7; p=0.019), respectively. Corneal sensation increased from 2.3±1.1cm pre-treatment to 4.1cm post-treatment; p=0.001).
Conclusions :
Patients with NK treated with at least 4 weeks of cenegermin 0.002% showed an overall increase in total, main, and branch nerve densities and a significant increase in corneal sensation.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.