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

NCT ID: NCT04343326

Last Updated: 2020-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

perform corneal collagen cross linking accelerated and delivery of systemic oxygen

Intervention Type: 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 collagen cross-linking

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

Group Type: ACTIVE_COMPARATOR

perform corneal collagen cross linking accelerated and without additional oxygen therapy

Intervention Type: PROCEDURE

corneal collagen cross linking with accelerated protocol without additional oxygen therapy

conventional corneal collagen cross-linking

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

Group Type: ACTIVE_COMPARATOR

perform Conventiona corneal collagen cross linking

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

perform corneal collagen cross linking accelerated and without additional oxygen therapy

corneal collagen cross linking with accelerated protocol without additional oxygen therapy

Intervention Type: PROCEDURE

perform Conventiona corneal collagen cross linking

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Head of department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ophthalmic Research Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Amir Faramarzi, MD

Role: CONTACT

labbafi@hotmil.com

009822591616

Facility Contacts

Amir Faramarzi, MD

Role: primary

labbafi@hotmail.com

009822591616

References

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.

Reference Type: DERIVED

PMID: 33252568 (View on PubMed)

Other Identifiers

9900

Identifier Type: -

Identifier Source: org_study_id