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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05019768
• Other study ID #: 127
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Corneal Transplant Center, Pellegrini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• documented progressive keratoconus
• changes in uncorrected distance visual acuity (UDVA) above 1.00 D
• Corrected distance visual acuity (BCVA) above 1.00 D
• spherical equivalent greater than 0.50 D

Exclusion Criteria:

• Corneal pachymetry of less than 400 µm
• less than 2000 cells/cm2,
• corneal scarring,
• nystagmus or any motility disorder that prevented a fixed gaze during the examination
• Current contact lens use

Related Conditions & MeSH terms

• Keratoconus

Intervention

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
• Standard CXL
The standard CXL procedure has been carried on following the Dresden protocol

Locations

Country	Name	City	State
Italy	Pellegrini Hospital	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Ciro Caruso

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Topographical parameters	Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters	2 years
Secondary	Refractive parameters	Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)	2 years
Secondary	Refractive parameters	Spherical equi-valent: diopters Refractive cylinder magnitude: diopters	2 years
Secondary	Biomechanical parameters	Corneal hysteresis: mmHg	2 years