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

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04343326
• Other study ID #: 9900
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Amir Faramarzi, MD
• Phone: 009822591616
• Email: labbafi[@]hotmil.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconus

Intervention

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
• perform corneal collagen cross linking accelerated and without additional oxygen therapy
corneal collagen cross linking with accelerated protocol without additional oxygen therapy
• perform Conventiona corneal collagen cross linking
Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative refractive error	Sirius and ocular response analyzer	12 months
Secondary	Ocular biomechanics	Ocular response analyzer	6 months