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

• Sponsor: Ciro Caruso (Other)
• Overall Status: Completed
• CT.gov ID: NCT05019768
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 40
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Other: accelerated custom-fast CXL; Other: Standard CXL	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Sep 1, 2017
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: sCXL 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; The standard CXL procedure has been carried on following the Dresden protocol
Experimental: aCFXL 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; 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

Outcome Measures

Primary Outcome Measures

1. Topographical parameters [2 years]

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

Secondary Outcome Measures

1. Refractive parameters [2 years]

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

2. Refractive parameters [2 years]

   Spherical equi-valent: diopters Refractive cylinder magnitude: diopters

3. Biomechanical parameters [2 years]

   Corneal hysteresis: mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pellegrini Hospital	Napoli		Italy

Sponsors and Collaborators

• Ciro Caruso

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Ciro Caruso, MD, Head of Corneal Transplant Center, Corneal Transplant Center, Pellegrini Hospital
• ClinicalTrials.gov Identifier: NCT05019768
• Other Study ID Numbers: 127
• First Posted: Aug 25, 2021
• Last Update Posted: Aug 30, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratoconus

Study Results

No Results Posted as of Aug 30, 2021