MyopiaPhase 4NCT02071576
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK
A Phase 4 study testing Proscan in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH at 1 site in China.
Trial summary
This clinical study has been planned to evaluate the safety and effectiveness of a common treatment algorithms (Proscan) using 500 Hz laser repetition rate. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Proscan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Aug 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
- 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.
- Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 and 12 months respectively after surgery.
- Corneal topography should be qualified
- 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 (Snellen 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).
- 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.
- Myopic subjects require a sphere between -0.5 D up to -10.0 D and cylinder between -0.5 D up to -4.0 D (not corneal astigmatism) and SE up to -12.0 D
- Hyperopic subjects require a sphere between +0.5 D up to +4.0 D and cylinder between +0.5 D up to +4.0 D (not corneal astigmatism) and SE up to +6.0 D.
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.
China1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Andrew Lam, Dr., +85227666109, andrew.kc.lam@polyu.edu.hk
Jimmy Tse, +85290181592, jimmy.sh.tse@polyu.edu.hk
About this study
This clinical study has been planned to evaluate the safety and effectiveness of a common treatment algorithms (Proscan) 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 algorithm Proscan of the 500 Hz laser system for ametropia when performed on the cornea of virgin eyes.
- Being tested
- Proscan
- Keywords
- Myopia, Hyperopia, Proscan, LASIK, TENEO, Excimer
- Medical subject headings
- Myopia, Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProscanDevice
One device (500 Hz Excimer Laser - TENEO) with one intervention (Proscan)
| Study group | Role | What they receive |
|---|---|---|
| Proscan | Experimental | Ametropia Lasik treatment of virgin eyes Receives: Device: Proscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of treated eyes within +/- 0.50D of target refraction
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victor Woo, MD, Principal investigator, Hong Kong Laser Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071576
- Sponsor's protocol ID
- 1215
- Status last verified
- Nov 2014
- First submitted
- 30 Jan 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 the 500 Hz Technolas Perfect Vision Excimer Laser Using LASIK
- ClinicalTrials.gov ID
- NCT02071576
- Acronym / sponsor ID
- 1215
- Keywords
- Myopia, Hyperopia, Proscan, LASIK, TENEO, Excimer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Feb 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 a common treatment algorithms (Proscan) 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 algorithm Proscan of the 500 Hz laser system for ametropia when performed on the cornea of virgin eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proscan | Experimental | Device: ProscanAmetropia 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 (8 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.
- Subjects have to be willing and able to return for scheduled follow-up examinations for up to 6 and 12 months respectively after surgery.
- Corneal topography should be qualified
- 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 (Snellen 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).
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 |
|---|---|---|
| ProscanOne device (500 Hz Excimer Laser - TENEO) with one intervention (Proscan) | Device | Proscan |
Primary outcome
The percentage of treated eyes within +/- 0.50D of target refraction
Time frame: 6 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.
Victor Woo, MD principal investigator
Hong Kong Laser Eye Centre
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 in people with Myopia and Hyperopia, run by Technolas Perfect Vision GmbH at 1 site in China.
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 8 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 Nov 2014. 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 China. 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 Andrew Lam, Dr. (+852-27666109, andrew.kc.lam@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of treated eyes within +/- 0.50D of target refraction (time frame: 6 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.