NCT04343326

The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Keratoconus

Interventions

Type	Name	Description
PROCEDURE	perform corneal collagen cross linking accelerated and delivery of systemic oxygen	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
PROCEDURE	perform corneal collagen cross linking accelerated and without additional oxygen therapy	corneal collagen cross linking with accelerated protocol without additional oxygen therapy
PROCEDURE	perform Conventiona corneal collagen cross linking	Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-05-01
• Completion: 2020-06-01
• First posted: 2020-04-13
• Last updated: 2020-04-13

Locations

1 site across 1 country: Iran