Status:
UNKNOWN
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Keratoconus
Eligibility:
All Genders
Up to 35 years
Phase:
PHASE2
PHASE3
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 progre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04343326
Start Date
January 1 2020
End Date
June 1 2020
Last Update
April 13 2020
Active Locations (1)
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1
Ophthalmic Research Center
Tehran, Iran