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

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05019768

Enrollment

Registered

2021-08-25

Start date

2017-09-01

Completion date

2020-12-31

Last updated

2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Brief 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.

Interventions

OTHERaccelerated 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

OTHERStandard CXL

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Topographical parameters	2 years	Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters

Secondary

Measure	Time frame	Description
Refractive parameters	2 years	Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)
Biomechanical parameters	2 years	Corneal hysteresis: mmHg

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026