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

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04343326
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 5
• Patients Per Site Per Month: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygen; Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy; Procedure: perform Conventiona corneal collagen cross linking	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
• Actual Study Start Date: Jan 1, 2020
• Anticipated Primary Completion Date: May 1, 2020
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	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
Active Comparator: accelerated corneal collagen cross-linking corneal cross linking with the same accelerated protocol without additional oxygen therapy.	Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapy; corneal collagen cross linking with accelerated protocol without additional oxygen therapy
Active Comparator: conventional corneal collagen cross-linking Conventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes	Procedure: perform Conventiona corneal collagen cross linking; Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes

Outcome Measures

Primary Outcome Measures

1. Postoperative refractive error [12 months]

   Sirius and ocular response analyzer

Secondary Outcome Measures

1. Ocular biomechanics [6 months]

   Ocular response analyzer

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zahra Rabbani Khah, Head of department, Shahid Beheshti University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT04343326
• Other Study ID Numbers: 9900
• First Posted: Apr 13, 2020
• Last Update Posted: Apr 13, 2020
• Last Verified: Apr 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Keratoconus; Menthol

Study Results

No Results Posted as of Apr 13, 2020