Cornea
Conditions
Keywords
Cornea, Diabetes, Neural damage
Brief summary
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.
Detailed description
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry \< 45 mm \[6\] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN). Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted. The randomization will be operator-masked.
Interventions
DEVICEOMK2
OMK2 (including citicoline 2%, high molecular weight hyaluronic acid 0.2%, cyanocobalamin and 0.01% BAK, Omikron Italia SRL) is a Class IIa device CE marked registered in Medical Devices Database of Italian Ministry of Health (identification number of registration: 1170558).
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* At least 18 years old * Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation
Exclusion criteria
* Neuropathy of any other cause than diabetes * A history of conditions known to affect corneal sensitivity * Coexisting other corneal diseases * Autoimmune diseases * Sjogren syndrome * History of corneal trauma * Contact lenses users * Patients needing eye surgery or who received eye surgery at least 180 days before study beginning. * contraindications to the use of any active substances and/or excipients * pregnant and lactating women * pediatric patients or adolescents under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the characteristics of the subbasal corneal plexus at confocal | Change measure (baseline and month 18) | changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants four quadrants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - changes in clinical signs and symptoms of ocular surface damage | Change measure (baseline and month 18) | * changes in clinical signs of corneal damage (BUT, Schirmer I, corneal and conjunctival epithelial staining using Oxford and Van Bijelsterveld scales, both ranging between 0 - normal, to 4 - severely affected; a change of 1 or more stage is defined as clinically relevant) * changes in symptoms (OSDI) |
Countries
Italy
Outcome results
None listed