The purpose of this study is to determine whether poly（β-amino ester）(PAE)hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes(tRF-ASO-Exo) could alleviate symptoms in patients with diabetic ocular surface diseases(DOSD).
1. Patients with fasting blood glucose ≥ 7.0 mmol/L or 2-hour postprandial blood glucose ≥ 11.1 mmol/L.
Any past or current malignancy in or around the eye.
Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).
Active ocular allergy now or expected during the study.
Ocular or systemic infection at screening/baseline-fever, herpetic keratitis, or on antibiotics.
Parallel
Exosomes
DrugParticipants will receive artificial tears for 2 weeks to get the normalized baseline, followed by Exosomes 10ug/drop, two times a day for 84 days. The follow-up visit will be 12 weeks.
tRNA-derived fragments-antisense oligonucleotides-exosomes
DrugParticipants will receive artificial tears for 2 weeks to get the normalized baseline, followed by tRF-ASO-Exo 10ug/drop, two times a day for 84 days. The follow-up visit will be 12 weeks.
poly（β-amino ester）hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes
DrugParticipants will receive artificial tears for 2 weeks to get the normalized baseline, followed by tRF-ASO-Exo-PAE 10ug/drop, two times a day for 84 days. The follow-up visit will be 12 weeks.
corneal and conjunctival nerve density
In vivo confocal microscopy (IVCM) examination: All subjects underwent IVCM to assess corneal and conjunctival nerve density. Instruct the patient to fixate on a target, and the examiner slowly moves the objective lens until the vortex structure of the subbasal nerve plexus of the cornea can be seen.
Corneal sensitivity
Corneal sensitivity of the operated eye was evaluated by one examiner via a French Cochet-Bonnet aesthesiometer (Luneau Ophthalmologie), which consists of a calibrated nylon filament on a retractable shaft with a length scale. Longer filaments (lower bending force, weaker stimulus) indicate higher sensitivity. The sensitivity threshold was the maximum filament length evoking a reliable blink response. All tests were conducted in a standardized quiet indoor setting; patients kept eyes open with stable gaze during testing. Starting at 60 mm, the filament was perpendicularly applied to the central cornea, then shortened by 5 mm increments until consistent blinks occurred. Three measurements were taken, and corneal sensitivity was defined as the mean length of positive responses.
conjunctival goblet cell density
All participants underwent in vivo confocal microscopy (IVCM) assessment of conjunctival goblet cell density. Prior to imaging, subjects were instructed to maintain steady fixation on a standardized external target. The examiner systematically scanned the temporal bulbar conjunctiva approximately 3 mm from the corneal limbus, using the "section" scanning mode to acquire high-resolution images of the conjunctival epithelium-including the vortex region and its surrounding tissue within a 2-3 mm radius. To ensure optimal image quality and anatomical coverage, four non-overlapping image fields were captured per eye, each centered on a distinct location within a predefined small target zone. A sterile, single-use plastic cap was gently applied to the conjunctival surface prior to scanning to stabilize the ocular surface and minimize motion artifact. A total of 100-200 well-focused, artifact-free images were acquired for each examined eye.
Changes in Ocular Surface Staining
Ocular surface integrity was checked with a non-toxic dye at the slit lamp. Corneal and conjunctival staining were graded with the NEI photo atlas; lower scores mean less dry-eye damage. Change-from-baseline numbers were calculated for each eye, so a negative value equals improvement.
Changes in tear secretion amount by Schirmer's Test
The examiner tucked a sterile paper strip beneath the lower lid, left it in place for the set time, then read the millimeters of strip the tears had traveled.
Changes in Tear break time
After a blink, the stopwatch ran until the first dry patch showed up on the ocular surface-time recorded in seconds.
Changes in best corrected visual acuity (BCVA)
to understand the effect of tRF-ASO-Exo-PAE on visual acuity
Changes in conjunctiva redness score
To explore the effect of tRF-ASO-Exo-PAE on conjunctiva. Under the slit lamp the investigator lined up each quadrant with the Allergan redness photos and handed out a 0-4 card: 0 = normal, vessels sharp; 1 = trace flush; 2 = mild; 3 = moderate; 4 = fiery severe-every step matched to its reference picture.
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