MyopiaPhase 4NCT02112968
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and Presbyopia
A Phase 4 study testing Proscan, Zyoptix and Supracor in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH.
Trial summary
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myopia, Hyperopia, Presbyopia
- What is being tested?
- Proscan, Zyoptix and Supracor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2017
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects have to be at least 18 years of age.
- Subjects have to be able to read, understand, and sign a statement of Informed Consent (be given a copy of the signed Informed Consent Form (ICF).
- Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 respectively 12 months after surgery.
- For Proscan and Zyoptix Treatments the myopic subjects require a sphere between -0.5 D up to a maximum sphere of -10.0 D. If the patient has a refractive astigmatism to be treated, this must be between -0.5 D up to -4.0 D (not corneal astigmatism) as expressed in spectacle minus cylinder form (by manifest subjective refraction). Overall the SE for myopes must be no more than -12.0 D.
- The Hyperopic subjects require a sphere between +0.5 D up to a maximum sphere of +4.0 D. If the patient has a refractive astigmatism to be treated, this must be between +0.5 D up to +4.0 D (not corneal astigmatism) as expressed in spectacle plus cylinder form (by manifest subjective refraction). Overall the SE for hyperopes must be no more than +6.0 D.
- Subjects who are contact lens wearers must have gas permeable lenses discontinued for at least 3 weeks and soft lenses discontinued for at least 1 week prior to the pre-operative evaluation in the eye to be treated.
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- Corneal topography should be qualified.
- Subjects who are contact lens wearers must have two (2) central keratometry readings and two (2) manifest subjective refractions taken pre-operatively at least one week apart. The refraction values must not differ by more than 0.50 D as defined by manifest refraction spherical equivalent (MRSE). The keratometry values must not differ from the previous values by more than 0.50 D in either meridian.
- High contrast, manifest, best spectacle-corrected distance visual acuity correctable binocular to at least 1.0 (Snellen 20/20 or 6/6) and monocular to at least 0.8 (Snel-len 20/25 or 6/7.5). In case of a monocular surgery the eye which should not be treated must have a best corrected distance visual acuity of at least 0.8 (Snellen 20/25 or 6/7.5).
- For treatments with the SUPRACOR presbyopic algorithm, subjects have to be at least 45 years old and no more than 85 years.
- For treatments with the SUPRACOR presbyopic algorithm, subjects must have presbyopia as determined by an age-related need for optical aid (> +1.50 D) for reading with their best distance correction and been screened successfully for acceptance of the SUPRACOR simulation.
- For treatments with the SUPRACOR presbyopic algorithm, subjects must been screened successfully for acceptance of the SUPRACOR simulation
- For treatments with the SUPRACOR presbyopic algorithm, Myopic subjects must have up to -7.0 diopters (D) of absolute spherical myopia (not spherical equivalent), with up to -4.0 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction. The spherical equivalent and must be no more than -9.0 D.
- Hyperopic subjects must have up to +4 diopters (D) of absolute spherical hyperopia (not spherical equivalent), with up to +2.5 D of refractive astigmatism (NOT corneal astigmatism) by manifest subjective refraction in both eyes. The spherical equivalent must be no more than +5.25 D.
- Mesopic pupil size measured with the Zywave II WaveFront Aberrometer must be < 7.0 mm and photopic pupil size measured with the Orbscan II/ IIz must be > 2.9 mm.
- For treatments with the Zyoptix algorithm, the high-order-aberration must be at least 0.35µm.
Who cannot join
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
- Hyperopic eyes for which the baseline manifest subjective refraction exhibits a difference of greater than ± 0.75 D in sphere power, or a difference of greater than ± 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than ±0.75 D, the difference in cylinder axis would not be taken into consideration.
- Any subject who is going to be co-managed by an ophthalmologist or optometrist who were not approved as a Technolas Perfect Vision Investigator.
- Subjects with anterior segment pathology, including dry eye syndrome and cataracts, which in the Investigator's opinion would interfere with best spectacle-corrected visual acuity or a successful treatment.
- Subjects with evidence of retinal vascular disease.
- Subjects with any residual, recurrent, or active ocular disease, or corneal abnormality that in the Investigator's opinion would interfere with BSCVA or a successful treatment.
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- Subjects with signs of keratoconus.
- Subjects with unstable central keratometry readings with irregular mires.
- Subjects who had previous intraocular or corneal surgery of any kind, including any type of Excimer laser surgery for either refractive or therapeutic purposes.
- Subjects who have a history of Herpes simplex or Herpes zoster keratitis.
- Subject who have a history of glaucoma or glaucoma suspect.
- Subjects with corneal edema, or increased IOP > 22mmHg.
- Subjects at risk for angle closure.
- Subjects immunocompromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, diabetes, autoimmune diseases and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
- Subject taking systemic medications likely to affect wound healing such as corticosteroids or antimetabolites.
- Subjects who are known to be pregnant, lactating, or who plans to become pregnant over the course of the study.
- Subjects with known sensitivity to medications used for standard LASIK.
- Subjects participating in any other ophthalmic clinical trials during this clinical study.
- Subjects with an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
- Subjects with cognitive impairments or other vulnerable persons.
- Subjects with anterior or posterior synechiae.
Trial locations and contacts
No sites are listed yet.
About this study
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia
Read the detailed description
This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithms Proscan, Zyoptix and Supracor of the 500 Hz laser system for ametropia and/or presbyopia when performed on the cornea of virgin eyes.
- Conditions
- Myopia, Hyperopia, Presbyopia
- Being tested
- Proscan, Zyoptix, Supracor
- Keywords
- Myopia, Hyperopia, Presbyopia, Supracor, Zyoptix, Proscan, LASIK
- Medical subject headings
- Myopia, Hyperopia, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProscanProcedure or surgery
One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
ZyoptixProcedure or surgery
One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
SupracorProcedure or surgery
One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
| Study group | Role | What they receive |
|---|---|---|
| Proscan | Experimental | Ametropia Lasik treatment of virgin eyes. Receives: Procedure: Proscan |
| Zyoptix | Experimental | Wavefront based ametropia Lasik treatment of virgin eyes. Receives: Procedure: Zyoptix |
| Supracor | Experimental | Ametropia Lasik treatment of virgin eyes with presbyopia. Receives: Procedure: Supracor |
What is being measured
The primary outcome is the main question the study is designed to answer.
For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
Measured: Myopia: 6 months, Hyperopia 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2016 (estimated)
- Study completionMay 2017 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pavel Stodulka, M.D., Principal investigator, Gemini ocni centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112968
- Sponsor's protocol ID
- 1302
- Status last verified
- Nov 2014
- First submitted
- 10 Apr 2014
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and Presbyopia
- ClinicalTrials.gov ID
- NCT02112968
- Acronym / sponsor ID
- 1302
- Conditions
- Myopia, Hyperopia, Presbyopia
- Keywords
- Myopia, Hyperopia, Presbyopia, Supracor, Zyoptix, Proscan, LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 14 Apr 2014 (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.
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate for the correction of Ammetropia and Presbyopia
Detailed description
This clinical study has been planned to evaluate the safety and effectiveness of the excimer laser treatment algorithms Proscan, Zyoptix and Supracor of the 500 Hz laser system for ametropia and/or presbyopia when performed on the cornea of virgin eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Proscan | Experimental | Procedure: ProscanAmetropia Lasik treatment of virgin eyes. |
| Zyoptix | Experimental | Procedure: ZyoptixWavefront based ametropia Lasik treatment of virgin eyes. |
| Supracor | Experimental | Procedure: SupracorAmetropia Lasik treatment of virgin eyes with presbyopia. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects have to be at least 18 years of age.
- Subjects have to be able to read, understand, and sign a statement of Informed Consent (be given a copy of the signed Informed Consent Form (ICF).
- Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 respectively 12 months after surgery.
- For Proscan and Zyoptix Treatments the myopic subjects require a sphere between -0.5 D up to a maximum sphere of -10.0 D. If the patient has a refractive astigmatism to be treated, this must be between -0.5 D up to -4.0 D (not corneal astigmatism) as expressed in spectacle minus cylinder form (by manifest subjective refraction). Overall the SE for myopes must be no more than -12.0 D.
- The Hyperopic subjects require a sphere between +0.5 D up to a maximum sphere of +4.0 D. If the patient has a refractive astigmatism to be treated, this must be between +0.5 D up to +4.0 D (not corneal astigmatism) as expressed in spectacle plus cylinder form (by manifest subjective refraction). Overall the SE for hyperopes must be no more than +6.0 D.
Key exclusion criteria (21 listed)
- Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns of remaining posterior corneal thickness below the flap postoperatively.
- Hyperopic eyes for which the baseline manifest subjective refraction exhibits a difference of greater than ± 0.75 D in sphere power, or a difference of greater than ± 0.50 D in cylinder power, or a difference in cylinder axis of more than 15 degrees compared to the baseline cycloplegic subjective refraction. For manifest cylinder of less than ±0.75 D, the difference in cylinder axis would not be taken into consideration.
- Any subject who is going to be co-managed by an ophthalmologist or optometrist who were not approved as a Technolas Perfect Vision Investigator.
- Subjects with anterior segment pathology, including dry eye syndrome and cataracts, which in the Investigator's opinion would interfere with best spectacle-corrected visual acuity or a successful treatment.
- Subjects with evidence of retinal vascular disease.
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 |
|---|---|---|
| ProscanOne device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms) | Procedure or surgery | Proscan |
| ZyoptixOne device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms) | Procedure or surgery | Zyoptix |
| SupracorOne device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms) | Procedure or surgery | Supracor |
Primary outcome
For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better
Time frame: Myopia: 6 months, Hyperopia 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
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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.
Pavel Stodulka, M.D. principal investigator
Gemini ocni centrum
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proscan, Zyoptix and Supracor in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH.
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 16 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie Doerner (+49 89 94004130, melanie.doerner@bausch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
For Proscan and Zyoptix: - The percentage of treated eyes within +/- 0.50D of target refraction. For Supracor: - The percentage of treated eyes with a best corrected high contrast distance VA of Snellen 20/25 (6/7.5 or 0.1 logMAR) or better (time frame: Myopia: 6 months, Hyperopia 12 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 20 Nov 2014.