MyopiaPhase 4NCT01977807
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIK
A Phase 4 study testing Proscan, Zyoptix and Supracor in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH at 1 site in Philippines.
Trial summary
This clinical study has been planned to evaluate the safety and effectiveness of common treatment algorithms using 500 Hz laser repetition rate. 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
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePhilippines
- Study dates
- Aug 2014to Dec 2016
- 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
None listed.
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 differ-ence in cylinder axis would not be taken into consideration.
- 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.
- Subjects with signs of keratoconus or 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.
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- Subjects who have a history of Herpes simplex or Herpes zoster keratitis or history of glaucoma or glaucoma suspect, corneal edema, or increased IOP > 22mmHg or 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 an ocular muscle disorder including a strabismus or nystagmus, or other disorders affecting fixation.
- Subjects with cognitive impairments or other vulnerable persons.
Trial locations and contacts
1 site in 1 country.
Gino Lagrosa contact
Philippines1 site, 1 recruiting
- Recruiting
Asian Eye Institut
Manila, 1200
Mary Ann Catacutan, Dr., mtcatacutan@asianeyeinstitute.com
Gino Antonio Lagrosa, gclagrosa@asianeyeinstitute.com
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.
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 and 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.
Proscan, Zyoptix and SupracorDevice
One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
| Study group | Role | What they receive |
|---|---|---|
| Myopia | Experimental | Myopia Lasik treatment of virgin eyes. Receives: Device: Proscan, Zyoptix and Supracor |
| Hyperopia | Experimental | Hyperopia Lasik treatment of virgin eyes. Receives: Device: Proscan, Zyoptix and 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 posted7 Nov 2013 (estimated)
- Study startAug 2014
- Primary completionDec 2016 (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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ang, M.D., Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977807
- Sponsor's protocol ID
- 1303
- Status last verified
- May 2015
- First submitted
- 31 Oct 2013
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIK
- ClinicalTrials.gov ID
- NCT01977807
- Acronym / sponsor ID
- 1303
- Conditions
- Myopia, Hyperopia, Presbyopia
- Keywords
- Myopia, Hyperopia, Presbyopia, Supracor, Zyoptix, Proscan, LASIK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 7 Nov 2013 (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.
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
- 2
| Arm | Type | Receives |
|---|---|---|
| Myopia | Experimental | Device: Proscan, Zyoptix and SupracorMyopia Lasik treatment of virgin eyes. |
| Hyperopia | Experimental | Device: Proscan, Zyoptix and SupracorHyperopia Lasik treatment of virgin eyes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 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 differ-ence in cylinder axis would not be taken into consideration.
- 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.
- Subjects with signs of keratoconus or Subjects with unstable central keratometry readings with irregular mires.
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 |
|---|---|---|
| Proscan, Zyoptix and SupracorOne device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms) | Device | Hyperopia, Myopia |
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 May 2015.
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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.
Gino Lagrosa contact
Robert Ang, M.D. principal investigator
Asian Eye Institute
1 site in 1 country: see every site and its status.
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 at 1 site in Philippines.
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 0 inclusion and 12 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 May 2015. 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 Philippines. 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 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 Shiela De Castro (0915-267-0541, SSDeCastro@asianeyeinstitute.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 May 2015.