MyopiaPhase 2/3NCT04452448
Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
A Phase 2/3 study testing LASIK in people with Myopia, run by Alexandria University at 1 site in Egypt.
Trial summary
This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myopia
- What is being tested?
- LASIK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2018to 10 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Myopia up to -8.0 D and astigmatism up to -2.0D.
- Cases above 18 years of age with a stable refraction for at least one year.
Who cannot join
- Keratoconus.
- Patients with collagen diseases.
- Previous LASIK or any other refractive surgery.
- Severe dry eye syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)
Read the detailed description
The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)
- Conditions
- Myopia
- Being tested
- LASIK
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASIKDevice
All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.
| Study group | Role | What they receive |
|---|---|---|
| Laser in situ keratomileusis | Experimental | A prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK) Receives: Device: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of ocular aberrations
- Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery
Measured: 3 months
Visual acuity
Unaided as well as best corrected visual acuity
Measured: 3 months
Manifest refraction
Manifest refraction
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Jan 2018
- Primary completion30 May 2020
- Study completion10 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehab Mossallam, PhD, Principal investigator, Alexandria Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452448
- Sponsor's protocol ID
- 030490
- Status last verified
- Jun 2020
- First submitted
- 26 Jun 2020
- Last updated
- 30 Jun 2020
- 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 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of I-Trace High Order Aberrations Induced by Wavefront Optimized Ablation Profiles
- ClinicalTrials.gov ID
- NCT04452448
- Acronym / sponsor ID
- 030490
- Conditions
- Myopia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 30 Jun 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.
This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)
Detailed description
The iTrace (Tracey Technologies, Houston, Tx) is uniquely designed to combine Placido corneal topography with a ray tracing aberrometer to measure quality of vision in a patient. This work aims at the analysis of ocular aberrations induced by wave front optimized ablation profiles WFO using I-Trace aberrometer (Ray -Tracing)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective clinical study including 20 eyes of 10 cases undergoing LASIK with wave front optimized ablation profile
| Arm | Type | Receives |
|---|---|---|
| Laser in situ keratomileusis | Experimental | Device: LASIKA prospective clinical study including 20 eyes of 10 cases undergoing laser in situ keratomileusis (LASIK) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Myopia up to -8.0 D and astigmatism up to -2.0D.
- Cases above 18 years of age with a stable refraction for at least one year.
Key exclusion criteria (4 listed)
- Keratoconus.
- Patients with collagen diseases.
- Previous LASIK or any other refractive surgery.
- Severe dry eye syndrome.
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 |
|---|---|---|
| LASIKAll cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases. | Device | Laser in situ keratomileusis |
Primary outcome
Evaluation of ocular aberrations
Time frame: 3 months
3. Evaluation of ocular aberrations done using iTrace Visual Functional Analyzer (ray tracing technology) to quantify changes in total higher order aberrations, coma, spherical aberrations, secondary astigmatism and trefoil after LASIK surgery
Visual acuity
Time frame: 3 months
Unaided as well as best corrected visual acuity
Manifest refraction
Time frame: 3 months
Manifest refraction
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 30 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Ehab Mossallam, PhD principal investigator
Alexandria Faculty of Medicine
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 LASIK in people with Myopia, run by Alexandria 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 2 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 30 Jun 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 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.
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?
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 ocular aberrations (time frame: 3 months). The study lists 3 primary outcomes in all. 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 30 Jun 2020.