NCT05019768

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 25, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

3.3 years

First QC Date

August 10, 2021

Last Update Submit

August 24, 2021

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Topographical parameters

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

    2 years

Secondary Outcomes (3)

  • Refractive parameters

    2 years

  • Refractive parameters

    2 years

  • Biomechanical parameters

    2 years

Study Arms (2)

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

Other: Standard CXL

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

Other: accelerated custom-fast CXL

Interventions

accelerated custom-fast CXLOTHER

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

aCFXL
Standard CXLOTHER

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

sCXL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pellegrini Hospital

Napoli, Italy

Location

Related Publications (2)

  • 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.

    PMID: 26606293BACKGROUND

  • 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.

    PMID: 28257382BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, Head of Corneal Transplant Center

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 25, 2021

Study Start

September 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)