KeratoconusNCT05395650
Cyanocobalamin as Photosensitizing Agent
An observational study of Keratoconus, run by EL Romany Ophthalmics Factory.
Trial summary
is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Keratoconus
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Observational
- 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 20 to 40 years
- All sexes
- Adult
Study population: primary care
Who may be able to join
- - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;
Who cannot join
- Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
About this study
Official title: Cyanocobalamin as Photosensitizing Agent Using to Make Cross-linking to Cornea Collagen in Treatment of Progressive Keratoconus
is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea
- Conditions
- Keratoconus
- Medical subject headings
- Keratoconus
What is being measured
The primary outcome is the main question the study is designed to answer.
PRESERVATION of presence of red flare by using slit lamb
Cyanocobalamin react with cornea collagen and format red flare
Measured: Base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EL Romany Ophthalmics Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Mina ibrahim shalalpy, EL Romany Ophthalmics Factory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395650
- Sponsor's protocol ID
- CYHEMG
- Status last verified
- Feb 2023
- First submitted
- 25 May 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyanocobalamin as Photosensitizing Agent Using to Make Cross-linking to Cornea Collagen in Treatment of Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT05395650
- Acronym / sponsor ID
- CYHEMG
- Conditions
- Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- EL Romany Ophthalmics FactoryIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 May 2022 (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.
is cyanocobalamin active as Photosensitizing Agent instead of riboflavin ? using cyanocobalamin with mix of external collagen to make crosslinking with cornea collagen to make rigid of cornea
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Age groups
- Adult
- Study population
- primary care
Key inclusion criteria (1 listed)
- - Is 20 years or older Has been diagnosed with Keratoconus; Has no other active ocular disease; Is not pregnant or nursing;
Key exclusion criteria (1 listed)
- Is under the age of 20 Has best corrected visual acuity outside 20/400; Pregnant or nursing at the time of enrollment in the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PRESERVATION of presence of red flare by using slit lamb
Time frame: Base line
Cyanocobalamin react with cornea collagen and format red flare
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus, run by EL Romany Ophthalmics Factory.
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 1 inclusion and 1 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PRESERVATION of presence of red flare by using slit lamb (time frame: Base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2023.