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

Ciro Caruso

Status: Completed

Conditions: Keratoconus

Treatments: Other: accelerated custom-fast CXL; Other: Standard CXL

Study type: Interventional

Funder types: Other

Identifiers

NCT05019768

127

Details and patient eligibility

About

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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

sCXL

Active Comparator group

Description:

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

Treatment:

Other: Standard CXL

aCFXL

Experimental group

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

Treatment:

Other: accelerated custom-fast CXL