IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)NCT04464083
IOP Measurements Using ORA After ACXL in Keratoconus
An observational study of IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL), run by Fayoum University at 1 site in Egypt.
Trial summary
The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)
- What is being tested?
- IOP Measurment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2020to 15 Oct 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: all patients with KC and indicated for CXL
Who may be able to join
- KC patient indicated for CXL
Who cannot join
- Advanced KC Glaucoma patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraocular Pressure Measurements Using Ocular Response Analyzer After Accelerated Corneal Collagen Crosslinking With Riboflavin and Ultraviolet A in Keratoconus
The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.
- Being tested
- IOP Measurment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOP MeasurmentDiagnostic test
To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine IOP readings before and after accelerated corneal collagen crosslinking
Measured: April-October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start12 Apr 2020
- Primary completion15 Oct 2020
- Study completion15 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL)Studies of the same condition, open and under way.
- More trials run by Fayoum UniversityThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Said, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464083
- Sponsor's protocol ID
- R110
- Status last verified
- Feb 2021
- First submitted
- 5 Jul 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: approval from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Pressure Measurements Using Ocular Response Analyzer After Accelerated Corneal Collagen Crosslinking With Riboflavin and Ultraviolet A in Keratoconus
- ClinicalTrials.gov ID
- NCT04464083
- Acronym / sponsor ID
- R110
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 12 Apr 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 15 Oct 2020 (actual)
- First posted
- 9 Jul 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.
The investigators measured IOP by Goldmann applanation tonometry(GAT) before and 6 months after accelerated 8 minutes CXL in using Avedro Kxl ,and correlated with corneal resistance factor(CRF)using ORA, AC angle and CCT using Scheimpflug imaging.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients with KC and indicated for CXL
Key inclusion criteria (1 listed)
- KC patient indicated for CXL
Key exclusion criteria (1 listed)
- Advanced KC Glaucoma patients
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 |
|---|---|---|
| IOP MeasurmentTo determine IOP readings before and after accelerated corneal collagen crosslinking (CXL) | Diagnostic test | – |
Primary outcome
To determine IOP readings before and after accelerated corneal collagen crosslinking
Time frame: April-October 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: Undecided. approval from the principal investigator
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IOP Readings Before and After Accelerated Corneal Collagen Crosslinking (CXL), run by Fayoum University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 3 Feb 2021. 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 Egypt. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine IOP readings before and after accelerated corneal collagen crosslinking (time frame: April-October 2020). 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 3 Feb 2021.