Keratoconus Clinical Trial
Official title:
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
It is aimed to investigate the role of supplemental systemic oxygen therapy during
accelerated corneal collagen crosslinking (CXL).
In this prospective randomized clinical trial, patients with progressive keratoconus who are
candidates for receiving CXL will be included. The patients will be randomized and allocated
to three different CXL protocol. In the first group (OA-CXL), CXL is performed using an
accelerated protocol (9 mW/ CM2 for 10 minutes) in addition to the delivery of systemic
oxygen with a rate of 5 liters/min through a nasal mask for 10 minutes during UV-A ablation.
Patients in the second group (A-CXL) will receive CXL with the same accelerated protocol
without additional oxygen therapy. Conventional CXL using 30 mW/CM2 UV-A ablation for 30
minutes is perfomed in the patients of the third goup (C-CXL). Maximum keratometry in Sirius
corneal tomography as the primary outcome and uncorrected and corrected distance visual
acuity (UDVA, CDVA) and corneal biomechanical properties including corneal resistance factor
(CRF) and corneal hysteresis (CH) as secondary outcome measures are followed for a six- and
12-months period. A P-value of less than 0.05 is considered as statistically significance
level.
n/a
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