The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
Primary Purpose
Keratoconus
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
perform corneal collagen cross linking accelerated and delivery of systemic oxygen
perform corneal collagen cross linking accelerated and without additional oxygen therapy
perform Conventiona corneal collagen cross linking
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconus
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
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
accelerated corneal cross linking+ delivery of systemic oxygen
accelerated corneal collagen cross-linking
conventional corneal collagen cross-linking
Arm 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
corneal cross linking with the same accelerated protocol without additional oxygen therapy.
Conventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes
Outcomes
Primary Outcome Measures
Postoperative refractive error
Sirius and ocular response analyzer
Secondary Outcome Measures
Ocular biomechanics
Ocular response analyzer
Full Information
NCT ID
NCT04343326
First Posted
April 9, 2020
Last Updated
April 9, 2020
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04343326
Brief Title
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
Official Title
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
accelerated corneal cross linking+ delivery of systemic oxygen
Arm Type
Active Comparator
Arm 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
Arm Title
accelerated corneal collagen cross-linking
Arm Type
Active Comparator
Arm Description
corneal cross linking with the same accelerated protocol without additional oxygen therapy.
Arm Title
conventional corneal collagen cross-linking
Arm Type
Active Comparator
Arm Description
Conventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes
Intervention Type
Procedure
Intervention Name(s)
perform corneal collagen cross linking accelerated and delivery of systemic oxygen
Intervention Description
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
Intervention Name(s)
perform corneal collagen cross linking accelerated and without additional oxygen therapy
Intervention Description
corneal collagen cross linking with accelerated protocol without additional oxygen therapy
Intervention Type
Procedure
Intervention Name(s)
perform Conventiona corneal collagen cross linking
Intervention Description
Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes
Primary Outcome Measure Information:
Title
Postoperative refractive error
Description
Sirius and ocular response analyzer
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Ocular biomechanics
Description
Ocular response analyzer
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amir Faramarzi, MD
Phone
009822591616
Email
labbafi@hotmil.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amir Faramarzi, MD
Phone
009822591616
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
33252568
Citation
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.
Results Reference
derived
Learn more about this trial
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
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