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This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment | Active Comparator | 20 patients will be treated with active treatment (OMK2) |
|
| Placebo | Placebo Comparator | 10 patients will be treated with placebo (lubricant eye drops) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMK2 | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| changes in the characteristics of the subbasal corneal plexus at confocal | changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants)
| Change measure (baseline and month 18) |
| Measure | Description | Time Frame |
|---|---|---|
| - changes in clinical signs and symptoms of ocular surface damage |
| Change measure (baseline and month 18) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Fogagnolo, MD | University of Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Santi Paolo e Carlo - Ospedale San Paolo | Milan | MI | 20142 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32738875 | Derived | Fogagnolo P, Melardi E, Tranchina L, Rossetti L. Topical citicoline and vitamin B12 versus placebo in the treatment of diabetes-related corneal nerve damage: a randomized double-blind controlled trial. BMC Ophthalmol. 2020 Aug 1;20(1):315. doi: 10.1186/s12886-020-01584-w. |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |