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

Not Applicable

Completed

• Conditions: Keratoconus
• Interventions: Other: Standard CXL; Other: accelerated custom-fast CXL

• Registration Number: NCT05019768
• Lead Sponsor: Ciro Caruso

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-19
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sCXL	Standard CXL	Standard protocol of Dresden Riboflavin-VEPTGS solution applied every 2 mins during UV UVA fluence of 3mW/cm2 UVA Irradiation time 30 minutes
aCFXL	accelerated custom-fast CXL	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

Primary Outcome Measures

Name	Time	Method
Topographical parameters	2 years	Maximum keratometry: diopters Mean keratometry: diopters Minimum corneal tickness: diopters

Secondary Outcome Measures

Name	Time	Method
Refractive parameters	2 years	Spherical equi-valent: diopters Refractive cylinder magnitude: diopters
Biomechanical parameters	2 years	Corneal hysteresis: mmHg

Trial Locations

Locations (1)

Pellegrini Hospital; 🇮🇹 Napoli, Italy