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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
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
corneal collagen cross linking with accelerated protocol without additional oxygen therapy
Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes
Ophthalmic Research Center
Tehran, Iran
RECRUITINGPostoperative refractive error
Sirius and ocular response analyzer
Time frame: 12 months
Ocular biomechanics
Ocular response analyzer
Time frame: 6 months
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