MyopiaNCT00925041
Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia
A study testing Vedera KXS in people with Myopia, run by Glaukos Corporation at 1 site in Turkey (Türkiye).
Trial summary
The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Vedera KXS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2009to Aug 2011
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be undergoing surgery for the correction of myopia
- Intended treatment from -0.5 to -6.0 D of spherical myopia
- Must have 0.50 D or less astigmatic component.
- Must have bilateral physiologic myopia
- BSCVA of 20/25 or better in each eye
- Must have had a stable refraction (0.5 D or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old)
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- Patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation
- Must be at least 18 years of age
- Corneal topography must be normal, as judged by the investigator
- Must have a minimal corneal thickness of 475 microns
- Must sign a written Informed Consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for Informed Consent practices
- Must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment
Who cannot join
- Patients who are unable or unwilling to sign the informed consent form.
- Anterior segment pathology
- Residual, recurrent or active ocular disease
- Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
- History of herpes keratitis
- Patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing.
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- Irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus.
- Patients with known sensitivity to study medications.
- Intraocular pressure of > 23 mm Hg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect.
- Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
- Participation in other ophthalmic clinical trials during this clinical investigation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beyoglu Eye Research and Education Hospital
Istanbul
About this study
The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.
- Conditions
- Myopia
- Being tested
- Vedera KXS
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedera KXSDevice
one treatment with the Vedera KXS
| Study group | Role | What they receive |
|---|---|---|
| Kxl Vedera | Experimental | Not described Receives: Device: Vedera KXS |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCVA 20/40 or better
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 posted19 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionAug 2011
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.
- More trials run by Glaukos CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925041
- Sponsor's protocol ID
- Avedro T1
- Status last verified
- Apr 2021
- First submitted
- 18 Jun 2009
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia
- ClinicalTrials.gov ID
- NCT00925041
- Acronym / sponsor ID
- Avedro T1
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 19 Jun 2009 (estimated)
- 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 objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kxl Vedera | Experimental | Device: Vedera KXS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must be undergoing surgery for the correction of myopia
- Intended treatment from -0.5 to -6.0 D of spherical myopia
- Must have 0.50 D or less astigmatic component.
- Must have bilateral physiologic myopia
- BSCVA of 20/25 or better in each eye
Key exclusion criteria (11 listed)
- Patients who are unable or unwilling to sign the informed consent form.
- Anterior segment pathology
- Residual, recurrent or active ocular disease
- Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
- History of herpes keratitis
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 |
|---|---|---|
| Vedera KXSone treatment with the Vedera KXS | Device | Kxl Vedera |
Primary outcome
UCVA 20/40 or better
Time frame: 3 months
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 26 Apr 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vedera KXS in people with Myopia, run by Glaukos Corporation at 1 site in Turkey (Türkiye).
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 12 inclusion and 11 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 26 Apr 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 Turkey (Türkiye). 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?
UCVA 20/40 or better (time frame: 3 months). 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 26 Apr 2021.