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In the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard Dresden (sCXL) or the accelerated custom-fast (aCFXL) ultraviolet A irradiation protocol using riboflavin-D-α-Tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sCXL | Active Comparator | Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes |
|
| aCFXL | Experimental | Accelerated custom fast CXL protocol. The protocol has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin con-sumption rate and the corneal thickness at its thinnest point. Riboflavin-VEPTGS solution: Epithelial lavage before UV UVA fluence of 1.8 ±0.9 mW/cm2 UVA Irradiation time 10 ± 1.5 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| accelerated custom-fast CXL | Other | The accelerated custom fast CXL (aCFXL) has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin consumption rate and the corneal thickness at its thinnest point. By knowing both values, the mathematical model allows to objectively calculate both the exact UVA irradiation value (intensity), expressed in mW/cm2, and the irradiation time |
| Measure | Description | Time Frame |
|---|---|---|
| Topographical parameters | Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Refractive parameters | Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR) | 2 years |
| Refractive parameters | Spherical equi-valent: diopters Refractive cylinder magnitude: diopters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pellegrini Hospital | Naples | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26606293 | Background | Caruso C, Ostacolo C, Epstein RL, Barbaro G, Troisi S, Capobianco D. Transepithelial Corneal Cross-Linking With Vitamin E-Enhanced Riboflavin Solution and Abbreviated, Low-Dose UV-A: 24-Month Clinical Outcomes. Cornea. 2016 Feb;35(2):145-50. doi: 10.1097/ICO.0000000000000699. | |
| 28257382 | Background | Caruso C, Epstein RL, Ostacolo C, Pacente L, Troisi S, Barbaro G. Customized Corneal Cross-Linking-A Mathematical Model. Cornea. 2017 May;36(5):600-604. doi: 10.1097/ICO.0000000000001160. |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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|
| Standard CXL | Other | The standard CXL procedure has been carried on following the Dresden protocol |
|
| 2 years |
| Biomechanical parameters | Corneal hysteresis: mmHg | 2 years |