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

Shahid Beheshti University of Medical Sciences

Status and phase

Unknown

Phase 3

Phase 2

Conditions

Keratoconus

Treatments

Procedure: perform Conventiona corneal collagen cross linking

Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy

Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT04343326

9900

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

definitive diagnosis of progressive keratoconus for whom CXL is indicated were enrolled in this study
The indication is identified by a cornea specialist and was considered as follows.
Patients with the definitive diagnosis of KC who aged 18 or more were considered for the procedure if they had an increase of 1 D in Kmax or an increase of 1D in the manifest cylinder over the past 12 months.

Exclusion criteria

patients with the previous history of corneal surgery
corneal scar or pathologies like herpetic eye disease or severe dry eye
corneal thickness less than 400 micrometers
pregnant or nursing women
corneal Kmax more than 60
age over 35 years
severe ocular surface disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

30 participants in 3 patient groups

accelerated corneal cross linking+ delivery of systemic oxygen

Active Comparator group

Description:

corneal cross linking 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

Treatment:

Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygen

accelerated corneal collagen cross-linking

Active Comparator group

Description:

corneal cross linking with the same accelerated protocol without additional oxygen therapy.

Treatment:

Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy

conventional corneal collagen cross-linking

Active Comparator group

Description:

Conventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes