NCT05019768

Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS

Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS: Results of a 2-year Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Ciro Caruso · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
OTHER	accelerated custom-fast CXL	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
OTHER	Standard CXL	The standard CXL procedure has been carried on following the Dresden protocol

Timeline

• Start date: 2017-09-01
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2021-08-25
• Last updated: 2021-08-30

Locations

1 site across 1 country: Italy