KeratoconusPhase 2/3NCT04343326
The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
A Phase 2/3 study testing perform corneal collagen cross linking accelerated and delivery of systemic oxygen, perform corneal collagen cross linking accelerated and without additional oxygen therapy and perform Conventiona corneal collagen cross linking in people with Keratoconus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- perform corneal collagen cross linking accelerated and delivery of systemic oxygen, perform corneal collagen cross linking accelerated and without additional oxygen therapy and perform Conventiona corneal collagen cross linking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2020to 1 Jun 2020
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Amir Faramarzi, MD, 009822591616, labbafi@hotmail.com
About this study
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
- Being tested
- 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
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perform corneal collagen cross linking accelerated and delivery of systemic oxygenProcedure or surgery
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
perform corneal collagen cross linking accelerated and without additional oxygen therapyProcedure or surgery
corneal collagen cross linking with accelerated protocol without additional oxygen therapy
perform Conventiona corneal collagen cross linkingProcedure or surgery
Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygen |
| accelerated corneal collagen cross-linking | Active comparator | corneal cross linking with the same accelerated protocol without additional oxygen therapy. Receives: Procedure: perform corneal collagen cross linking accelerated and 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 Receives: Procedure: perform Conventiona corneal collagen cross linking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative refractive error
Sirius and ocular response analyzer
Measured: 12 months
Secondary outcomes (1)
Ocular biomechanics
Ocular response analyzer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Jan 2020
- Primary completion1 May 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343326
- Sponsor's protocol ID
- 9900
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 13 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33252568
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Role of Supplemental Oxygen Therapy in Accelerated Corneal Collagen Cross-linking in Progressive Keratoconus. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04343326
- Acronym / sponsor ID
- 9900
- Conditions
- Keratoconus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 13 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| accelerated corneal cross linking+ delivery of systemic oxygen | Active comparator | Procedure: perform corneal collagen cross linking accelerated and delivery of systemic oxygencorneal 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 | Procedure: perform corneal collagen cross linking accelerated and without additional oxygen therapycorneal cross linking with the same accelerated protocol without additional oxygen therapy. |
| conventional corneal collagen cross-linking | Active comparator | Procedure: perform Conventiona corneal collagen cross linkingConventional corneal cross linking using 30 mW/CM2 UV-A ablation for 30 minutes |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perform corneal collagen cross linking accelerated and delivery of systemic oxygenCXL 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 or surgery | accelerated corneal cross linking+ delivery of systemic oxygen |
| perform corneal collagen cross linking accelerated and without additional oxygen therapycorneal collagen cross linking with accelerated protocol without additional oxygen therapy | Procedure or surgery | accelerated corneal collagen cross-linking |
| perform Conventiona corneal collagen cross linkingConventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes | Procedure or surgery | conventional corneal collagen cross-linking |
Primary outcome
Postoperative refractive error
Time frame: 12 months
Sirius and ocular response analyzer
1 secondary outcome
Ocular biomechanics
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Derived from this study: PubMed 33252568Faramarzi 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing perform corneal collagen cross linking accelerated and delivery of systemic oxygen, perform corneal collagen cross linking accelerated and without additional oxygen therapy and perform Conventiona corneal collagen cross linking in people with Keratoconus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amir Faramarzi, MD (009822591616, labbafi@hotmil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative refractive error (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04343326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.