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Completed

NCT Number: NCT05019768

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

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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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pellegrini Hospital

Naples, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard CXL

Other

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

Primary outcomes

  1. Topographical parameters

    Time frame: 2 years

    Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters

Secondary outcomes

  1. Refractive parameters

    Time frame: 2 years

    Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)

  2. Refractive parameters

    Time frame: 2 years

    Spherical equi-valent: diopters Refractive cylinder magnitude: diopters

  3. Biomechanical parameters

    Time frame: 2 years

    Corneal hysteresis: mmHg

Sponsors and collaborators

Lead sponsor

Ciro Caruso

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 25, 2021
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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