NCT04343326

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

Status unknown Phase 2, PHASE3 Last updated 13 April 2020

What this trial tests

Phase 2, PHASE3 trial testing perform corneal collagen cross linking accelerated and delivery of systemic oxygen in Keratoconus in 30 participants. Status unknown.

Timeline

1 January 2020

Primary endpoint
1 May 2020

1 June 2020

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	1 January 2020
Primary completion	1 May 2020
Estimated completion	1 June 2020
Sites	1 location across Iran

Drugs / interventions tested

• perform corneal collagen cross linking accelerated and delivery of systemic oxygen
• perform corneal collagen cross linking accelerated and without additional oxygen therapy
• perform Conventiona corneal collagen cross linking

Conditions studied

• Keratoconus — all drugs for Keratoconus →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

Under 35, any sex, with Keratoconus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.