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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| accelerated corneal collagen cross-linking | Active Comparator | corneal cross linking with the same accelerated protocol 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative refractive error | Sirius and ocular response analyzer | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular biomechanics | Ocular response analyzer | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir Faramarzi, MD | Contact | 009822591616 | labbafi@hotmil.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Recruiting | Tehran | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33252568 | Derived | 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. |
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|
| perform corneal collagen cross linking accelerated and without additional oxygen therapy | Procedure | corneal collagen cross linking with accelerated protocol without additional oxygen therapy |
|
| perform Conventiona corneal collagen cross linking | Procedure | Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes |
|
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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