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

NCT04343326 | Unknown Phase 2

• 1 other identifier: 9900
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Postoperative refractive error

  Sirius and ocular response analyzer

  12 months

Secondary Outcomes (1)

• Ocular biomechanics

  6 months

Study Arms (3)

accelerated corneal cross linking+ delivery of systemic oxygen

ACTIVE COMPARATOR

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

accelerated corneal collagen cross-linking

ACTIVE COMPARATOR

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

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

conventional corneal collagen cross-linking

ACTIVE COMPARATOR

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

Procedure: perform Conventiona corneal collagen cross linking

Interventions

perform corneal collagen cross linking accelerated and delivery of systemic oxygen PROCEDURE

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

accelerated corneal cross linking+ delivery of systemic oxygen

perform corneal collagen cross linking accelerated and without additional oxygen therapy PROCEDURE

corneal collagen cross linking with accelerated protocol without additional oxygen therapy

accelerated corneal collagen cross-linking

perform Conventiona corneal collagen cross linking PROCEDURE

Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes

conventional corneal collagen cross-linking

Eligibility Criteria

• Age: Up to 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Related Publications (1)

• 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.

  PMID: 33252568 DERIVED

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Amir Faramarzi, MD

CONTACT

009822591616; labbafi@hotmil.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of department

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: January 1, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 13, 2020

Record last verified: 2020-04

Locations

IR (1)