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.

Study Overview

• Status: Unknown
• Conditions: Keratoconus
• Intervention / Treatment: Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygen; Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy; Procedure: perform Conventiona corneal collagen cross linking

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Amir Faramarzi, MD; Phone Number: 009822591616; Email: labbafi@hotmil.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Ophthalmic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: accelerated corneal cross linking+ delivery of systemic oxygen; 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	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
Active Comparator: accelerated corneal collagen cross-linking; corneal cross linking with the same accelerated protocol without additional oxygen therapy.	Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy; corneal collagen cross linking with accelerated protocol without additional oxygen therapy
Active Comparator: conventional corneal collagen cross-linking; Conventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes	Procedure: perform Conventiona corneal collagen cross linking; Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative refractive error	Sirius and ocular response analyzer	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular biomechanics	Ocular response analyzer	6 months

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Publications and helpful links

General Publications

• Faramarzi A, Hassanpour K, Rahmani B, Yazdani S, Kheiri B, Sadoughi MM. Systemic supplemental oxygen therapy during accelerated corneal crosslinking for progressive keratoconus: randomized clinical trial. J Cataract Refract Surg. 2021 Jun 1;47(6):773-779. doi: 10.1097/j.jcrs.0000000000000513.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 9, 2020
• First Posted (Actual): April 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus; Dermatologic Agents; Antipruritics; Menthol
• Other Study ID Numbers: 9900

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No