Corneal BiomechanicsNCT05377099
Evaluation of the Change in the DA Ratio, IR and SSI as Parameters of Corneal Biomechanics Post Different LVC Procedures
A study testing CORVIS in people with Corneal Biomechanics, run by Cairo University at 1 site in Egypt.
Trial summary
In the study, The Investigators will compare the participates' corneal biomechanical properties including: Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI) All measurements will be taken before and after 3 months of LVC. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Corneal Biomechanics
- What is being tested?
- CORVIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 30 Jan 2023
- Phase
- Interventional
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Age range 18 - 40 years.
- Normal eyes with normal tomographic indices.
- Patients with maximum mean refractive spherical equivalent (MRSE) of -7.00 diopters and with maximum astigmatism of -3.00 diopters.
Who cannot join
- • Patients with any other coexisting corneal diseases.
- Keratoconus eyes.
- Eyes with previous refractive corneal surgery.
- Patients with increased intraocular pressure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Change in the Deformation Amplitude Ratio, Integrated Radius and Stress Strain Index as Parameters of Corneal Biomechanics Post Different Laser Vision Correction Procedures
In the study, The Investigators will compare the participates' corneal biomechanical properties including:
Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)
All measurements will be taken before and after 3 months of LVC.
Read the detailed description
Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative.
The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK.
Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.
- Conditions
- Corneal Biomechanics
- Being tested
- CORVIS
- Keywords
- CORVIS - Corneal Biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORVISDiagnostic test
Measurement of the DA ratio, IR and SSI before and after for patients under gone LASIK, femto LASIK and PRK using the CORVIS device.
| Study group | Role | What they receive |
|---|---|---|
| Laser In situ Keratomileusis (LASIK) | Active comparator | Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after LASIK Receives: Diagnostic Test: CORVIS |
| Femto-second assisted LASIK (FS-LASIK) | Active comparator | Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after Femto LASIK Receives: Diagnostic Test: CORVIS |
| Photorefractive Keratectomy (PRK) | Active comparator | Measurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after PRK Receives: Diagnostic Test: CORVIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC
Comparison between in DA ratio (DA ratio) in patients undergoing LASIK, Femto LASIK and PRK.
Comparison between changes in integrated Radius (IR) in patients undergoing LASIK, Femto LASIK and PRK.
Comparison between changes in Stress strain index (SSI) in patients undergoing LASIK, Femto LASIK and PRK.
Each indices will be compared before and after the Laser vision correction (LVC) procedure and the indices are not to be compared to each other to have have a fixed unit measure.
I reviewed your comment and I dont see any conflicts, to clarify how multiple measurements will be aggregated to arrive at one reported value again I am going to measure each index and compare it with "itself' before and after 3 different LVC.
Measured: 3-6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start1 Jan 2022
- Primary completion1 Aug 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal BiomechanicsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wessam Salem, Cairo University
- Investigators
- Mohamed Hosny, Principal investigator, Cairo UniversityMohamed Anis, Study director, Cairo UniversityWessam Salem, Study chair, Cairo UniversityMohamed ELnaggar, Study director, Research institute of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377099
- Sponsor's protocol ID
- MD 187-2020
- Status last verified
- Feb 2023
- First submitted
- 1 May 2022
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Change in the Deformation Amplitude Ratio, Integrated Radius and Stress Strain Index as Parameters of Corneal Biomechanics Post Different Laser Vision Correction Procedures
- ClinicalTrials.gov ID
- NCT05377099
- Acronym / sponsor ID
- MD 187-2020
- Conditions
- Corneal Biomechanics
- Keywords
- CORVIS - Corneal Biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 17 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.
In the study, The Investigators will compare the participates' corneal biomechanical properties including:
Deformation Amplitude ratio (Da Ratio) Integrated Radius (IR) Stress strain index (SSI)
All measurements will be taken before and after 3 months of LVC.
Detailed description
Each Participant will undergo preoperative pentacam and corvis scan for his eyes and the 3 months post operative.
The participants are divided into 3 groups, one who underwent LASIK, one PRK and one Femto LASIK.
Collected data will before and after surgery will be compared in each arm and then the 3 arms will be compared together.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laser In situ Keratomileusis (LASIK) | Active comparator | Diagnostic Test: CORVISMeasurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after LASIK |
| Femto-second assisted LASIK (FS-LASIK) | Active comparator | Diagnostic Test: CORVISMeasurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after Femto LASIK |
| Photorefractive Keratectomy (PRK) | Active comparator | Diagnostic Test: CORVISMeasurement of the deformation amplitude ratio, integrated radius and stress strain index as corneal biomechanical indices in refractive patients before and after PRK |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Age range 18 - 40 years.
Key exclusion criteria (4 listed)
- • Patients with any other coexisting corneal diseases.
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 |
|---|---|---|
| CORVISMeasurement of the DA ratio, IR and SSI before and after for patients under gone LASIK, femto LASIK and PRK using the CORVIS device. | Diagnostic test | Femto-second assisted LASIK (FS-LASIK), Laser In situ Keratomileusis (LASIK), Photorefractive Keratectomy (PRK) |
Primary outcome
Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC
Time frame: 3-6 months post operative
Comparison between in DA ratio (DA ratio) in patients undergoing LASIK, Femto LASIK and PRK. Comparison between changes in integrated Radius (IR) in patients undergoing LASIK, Femto LASIK and PRK. Comparison between changes in Stress strain index (SSI) in patients undergoing LASIK, Femto LASIK and PRK. Each indices will be compared before and after the Laser vision correction (LVC) procedure and the indices are not to be compared to each other to have have a fixed unit measure. I reviewed your comment and I dont see any conflicts, to clarify how multiple measurements will be aggregated to arrive at one reported value again I am going to measure each index and compare it with "itself' before and after 3 different LVC.
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 21 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Mohamed Hosny principal investigator
Cairo University
Mohamed Anis study director
Cairo University
Wessam Salem study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CORVIS in people with Corneal Biomechanics, run by Cairo 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 3 inclusion and 4 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 21 Feb 2023. 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?
Evaluation of the changes in DA ratio, integrated radius and SSI before and after LVC (time frame: 3-6 months post operative). 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 21 Feb 2023.