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Effects of corneal nerve density on the response to treatment in dry eye disease.

ABSTRACT: To evaluate whether levels of corneal subbasal nerve fiber length (SNFL) in dry eye disease (DED) could prognosticate the level of improvement in signs and symptoms after treatment.Phase IV, double-masked, randomized clinical trial.Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls.Patients with DED were randomized to receive topical artificial tears, loteprednol etabonate 0.5%, or loteprednol etabonate 0.5%/tobramycin 0.3% twice daily for 4 weeks. At baseline, in vivo confocal microscopy of central cornea was performed in both eyes. Patients with DED were divided into 2 subgroups: those with low baseline SNFL and those with near-normal baseline SNFL for this purpose (the cutoff point: the mean SNFL in controls minus 2 standard deviations). Clinical signs and symptoms at baseline and after 4 weeks of treatment were compared between the subgroups with low and near-normal SNFL for all therapeutic groups.Symptom questionnaires, corneal fluorescein staining (CFS), conjunctival staining with lissamine green, tear break-up time, Schirmer's test, and SNFL.In patients with DED, baseline SNFL (17.06±5.78 mm/mm(2)) was significantly lower than in controls (23.68±3.42 mm/mm(2), P = 0.001). In the artificial tear and loteprednol groups, although no significant improvement in any sign or symptom was noted in patients with low baseline SNFL (<16.84 mm/mm(2)), subjects with near-normal baseline SNFL (?16.84 mm/mm(2)) showed significant improvement in both symptoms and CFS score (all P < 0.05). In the loteprednol/tobramycin group, no significant change was evident for any sign or symptom in either subgroup of low or near-normal baseline SNFL.Significant improvements in CFS and patient symptomatology after DED treatment were evident only in the subgroup with near-normal corneal SNFL. Consideration of SNFL may assist in explaining the variability of patients' response to DED therapy.

SUBMITTER: Kheirkhah A

PROVIDER: S-EPMC4372494 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Effects of corneal nerve density on the response to treatment in dry eye disease.

Kheirkhah Ahmad A Dohlman Thomas H TH Amparo Francisco F Arnoldner Michael A MA Jamali Arsia A Hamrah Pedram P Dana Reza R

Ophthalmology 20141224 4

<h4>Purpose</h4>To evaluate whether levels of corneal subbasal nerve fiber length (SNFL) in dry eye disease (DED) could prognosticate the level of improvement in signs and symptoms after treatment.<h4>Design</h4>Phase IV, double-masked, randomized clinical trial.<h4>Participants</h4>Sixty patients with meibomian gland dysfunction-associated DED and 27 age-matched controls.<h4>Methods</h4>Patients with DED were randomized to receive topical artificial tears, loteprednol etabonate 0.5%, or lotepre ...[more]

PMID: 25542519

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Project description:PurposeTo report the subjective assessment of topical self-administered, cadaver-derived corneal epithelial stem cell supernatant for treatment of severe dry eye disease (DED).MethodsThirty-four eyes of 17 patients with advanced DED as defined by Standardized Patient Evaluation of Eye Dryness (SPEEDTM) questionnaire ≥14, Ocular Surface Disease Index (OSDI©) score ≥40 and documented attempt of at least six conventional dry eye therapies were enrolled into a prospective clinical trial at a single private practice institution. Treatment consisted of patient self-administered topical instillation of the corneal epithelial stem cell-derived product four times daily in both eyes for 12 weeks. Patient-reported outcome measures (PROMs) were taken with the SPEEDTM questionnaire (the main outcome variable), OSDI© score and visual analog score (VAS; UNC Dry Eye Management Scale©), and objective clinical measurements were taken with best-corrected visual acuity (BCVA), corneal topographic index measurements and tear film osmolarity. These measurements were compared at baseline versus the endpoint at completion of the 12-week treatment.ResultsAll 34 eyes tolerated the treatment without any adverse events or significant side effects. Compared with baseline, both the SPEEDTM questionnaire and the VAS significantly improved at the conclusion of the 12-week treatment (p = 0.0054 and p = 0.0202, respectively). The OSDI© improved by an average of 10.9 points after the treatment but was not statistically significant (p = 0.1409). There were no significant changes in any of the objective clinical measurements. None of the study subjects failed to complete the treatment course, experienced decrease in any of the PROMs or lost one or more lines of BCVA during the follow-up period.ConclusionTopical corneal epithelial stem cell-derived supernatant that can be self-administered by the patient shows promise at improving patient symptoms and quality of life in the setting of severe DED that is unresponsive to conventional therapies.

Dataset Information

Effects of corneal nerve density on the response to treatment in dry eye disease.

Publications

Effects of corneal nerve density on the response to treatment in dry eye disease.

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