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

Primary Purpose

Keratoconus

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
accelerated custom-fast CXL
Standard CXL
Sponsored by
Ciro Caruso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pellegrini Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

sCXL

aCFXL

Arm Description

Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Refractive parameters
Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)
Refractive parameters
Spherical equi-valent: diopters Refractive cylinder magnitude: diopters
Biomechanical parameters
Corneal hysteresis: mmHg

Full Information

First Posted
August 10, 2021
Last Updated
August 24, 2021
Sponsor
Ciro Caruso
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1. Study Identification

Unique Protocol Identification Number
NCT05019768
Brief Title
Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ciro Caruso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sCXL
Arm Type
Active Comparator
Arm Description
Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes
Arm Title
aCFXL
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
accelerated custom-fast CXL
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard CXL
Intervention Description
The standard CXL procedure has been carried on following the Dresden protocol
Primary Outcome Measure Information:
Title
Topographical parameters
Description
Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Refractive parameters
Description
Corrected distance acuity (BCVA): Logarithm of the Minimum Angle of Resolution (logMAR)
Time Frame
2 years
Title
Refractive parameters
Description
Spherical equi-valent: diopters Refractive cylinder magnitude: diopters
Time Frame
2 years
Title
Biomechanical parameters
Description
Corneal hysteresis: mmHg
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pellegrini Hospital
City
Napoli
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26606293
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.
Results Reference
background
PubMed Identifier
28257382
Citation
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.
Results Reference
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Topo-pachimetric Accelerated Epi-On Cross-linking Compared to Dresden Protocol Using Riboflavin With Vitamin E TPGS

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