MyopiaNCT03913338
Laser In-situ Keratomileusis With Crosslinking Compared to Conventional LASIK in Patients With High Myopia
A study testing LasikXtra and LASIK in people with Myopia and Myopic Astigmatism, run by University Clinic Frankfurt at 1 site in Germany.
Trial summary
The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopic Astigmatism, Crosslinking
- What is being tested?
- LasikXtra and LASIK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteGermany
- Study dates
- 24 Jul 2014to 3 Jul 2018
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism
- age > 18 years
- provided written informed consent
- difference between the MRSE and cycloplegic SE less than 0.75 D
- MRSE needed to be stable for the last 12 months (<0.5 D).
Who cannot join
- prior corneal surgery,
- forme fruste or manifest keratoconus,
- history of corneal scarring, melting, ulceration
- repeating inflammations of the eye
- taking vitamin C 1 week prior to the treatment
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of ophthalmology University clinic Frankfurt
Frankfurt am Main, Hesse, 60590
About this study
Official title: A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia
The objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.
Read the detailed description
This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking.
Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2.
All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.
- Conditions
- Myopia, Myopic Astigmatism, Crosslinking, Corneal Ectasia, Myopic Regression
- Being tested
- LasikXtra, LASIK
- Medical subject headings
- Myopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasikXtraProcedure or surgery
By randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA.
LASIKProcedure or surgery
Femtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Other | LASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap. Receives: Procedure: LasikXtra |
| Control group | Other | LASIK only Receives: Procedure: LASIK |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected distant visual acuity
uncorrected distant visual acuity (logarithmic minimum angle of resolution)
Measured: 12 months postoperative
best spectacle corrected distant visual acuity
best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
Measured: 12 months postoperative
spherical equivalent
spherical equivalent (diopter)
Measured: 12 months postoperative
Secondary outcomes (3)
endothelial cell count
endothelial cell count (number of cells/ mm2)
Measured: 12 months postoperative
Corneal thickness
Corneal thickness (micro millimeter)
Measured: 12 months postoperative
Subjective visual quality
Questionnaire regarding subjective optical quality (scale from 0 - 100; 0 = minimal, 100 = maximum)
Measured: 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start24 Jul 2014
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, intra-patient controlled, clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Collaborators
- Glaukos Corporation
- Responsible party
- Principal investigator, Professor Dr. med. Thomas Kohnen, University Clinic Frankfurt
- Investigators
- Thomas Kohnen, Prof. Dr., Principal investigator, Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913338
- Sponsor's protocol ID
- 154/14
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Evaluation of the Safety and Efficacy of Laser In-situ Keratomileusis With Crosslinking (XtraLASIK) Compared to Conventional LASIK (convLASIK) in Patients With High Myopia
- ClinicalTrials.gov ID
- NCT03913338
- Acronym / sponsor ID
- 154/14
- Conditions
- Myopia, Myopic Astigmatism, Crosslinking, Corneal Ectasia, Myopic Regression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Collaborators
- Glaukos Corporation
- Study start
- 24 Jul 2014 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 12 Apr 2019 (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 objectives of this study are to evaluate the safety and efficacy of a treatment regimen for high myopia and myopic astigmatism: LASIK followed by crosslinking performed with the KXL Crosslinking-System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA), as compared to LASIK alone, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE) and keratometry.
Detailed description
This is a controlled study of the safety and efficacy of the KXL System and VibeX Xtra (Riboflavin Ophthalmic Solution, Avedro, USA) for performing crosslinking in eyes undergoing LASIK for high myopia or myopic astigmatism. Each subject will have bilateral LASIK performed and one eye will be randomized to undergo LASIK followed by crosslinking.
Subjects will undergo bilateral LASIK. Following randomisation one eye of each subject will be treated with VibeX Xtra (Riboflavin Ophthalmic Solution) following LASIK and will be irradiated with the KXL System at 30 mW/cm2 intensity for 90 seconds continuous UV-A light treatment for a total radiant exposure of 2.7 J /cm2.
All eyes will be assessed at 1 day, 1, 3, 6, and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, intra-patient controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Other | Procedure: LasikXtraLASIK followed by intraoperative application of riboflavin under the flap and crosslinking after reposition of the flap. |
| Control group | Other | Procedure: LASIKLASIK only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- eligible for bilateral myopic fs-LASIK with -6.00 to -12.00 D (diopters) with a maximum of 5.00 D astigmatism
- age > 18 years
- provided written informed consent
- difference between the MRSE and cycloplegic SE less than 0.75 D
- MRSE needed to be stable for the last 12 months (<0.5 D).
Key exclusion criteria (5 listed)
- prior corneal surgery,
- forme fruste or manifest keratoconus,
- history of corneal scarring, melting, ulceration
- repeating inflammations of the eye
- taking vitamin C 1 week prior to the treatment
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 |
|---|---|---|
| LasikXtraBy randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA. | Procedure or surgery | Study group |
| LASIKFemtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens. | Procedure or surgery | Control group |
Primary outcome
uncorrected distant visual acuity
Time frame: 12 months postoperative
uncorrected distant visual acuity (logarithmic minimum angle of resolution)
best spectacle corrected distant visual acuity
Time frame: 12 months postoperative
best spectacle corrected distant visual acuity (logarithmic minimum angle of resolution)
spherical equivalent
Time frame: 12 months postoperative
spherical equivalent (diopter)
3 secondary outcomes
endothelial cell count
Time frame: 12 months postoperative
Corneal thickness
Time frame: 12 months postoperative
Subjective visual quality
Time frame: 12 months postoperative
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 12 Apr 2019.
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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.
Thomas Kohnen, Prof. Dr. principal investigator
Augenklinik des Universitätsklinikum der Goethe Unveristät Frankfurt am Main
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LasikXtra and LASIK in people with Myopia and Myopic Astigmatism, run by University Clinic Frankfurt at 1 site in Germany.
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 5 inclusion and 5 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 12 Apr 2019. 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 Germany. 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?
uncorrected distant visual acuity (time frame: 12 months postoperative). 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 12 Apr 2019.