HypermetropiaV1601CINCT03431571
Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia
A study testing ReLEx SMILE in people with Hypermetropia, run by Carl Zeiss Meditec AG at 8 sites in 6 countries.
Trial summary
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypermetropia
- What is being tested?
- ReLEx SMILE
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 5 Jul 2017to 31 Dec 2020
- 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
- Normal corneal topography;
- Predicted post-operative keratometry ≤51 D;
- Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
- Patients should be able to understand the patient information and willing to sign an informed consent;
- Patients should be willing to comply with all follow-up visits and the respective examinations;
- Patients with hyperopia or hyperopia with astigmatism (attempted correction: sphere up to +6.00D, cylinder up to 5.00D and maximum hyperopic meridian up to +7.00D);
- The corrected distance visual acuity should be 20/25 or better in each eye pre-operatively;
- A difference between cycloplegic and manifest refractions of ≤1.00 D spherical equivalent in the eye to be treated;
Who cannot join
- The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
- Mixed astigmatism
- Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
China2 sites
University Medical Center Shanghai
Shanghai
Tianjin Eye Hospital, Heping District
Tianjin
Germany2 sites
Medical Center Heliosklinikum
Erfurt
University Medical Center Universitätsklinikum Gießen Marburg
Marburg
About this study
Official title: Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
Read the detailed description
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.
- Conditions
- Hypermetropia
- Being tested
- ReLEx SMILE
- Keywords
- ReLEx, SMILE, Hyperopia, VisuMax, Small Incision Lenticule Extraction, Lenticule, Farsightedness
- Medical subject headings
- Hyperopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReLEx SMILEProcedure or surgery
the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | ReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group Receives: Procedure: ReLEx SMILE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corrected Distance Visual Acuity (CDVA)
CDVA in logMar
Measured: 12 months
Secondary outcomes (5)
side effects
distribution in percent
Measured: 12 months
contrast sensitivity
contrast sensitivities for all spatial frequencies (3, 6, 12 and 18 cpd) in logMar
Measured: 12 months
patient satisfaction (Quality of Vision Questionnaire)
Mean +/- standard deviation
Measured: 12 months
manifest refractive astigmatism
Astigmatism in diopters [D]
Measured: 12 months
spherical equivalent (SE)
SE in diopters [D]
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start5 Jul 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypermetropiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Sekundo, Principal investigator, Uniklinikum Gießen Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431571
- Sponsor's protocol ID
- V1601CI
- Acronym
- V1601CI
- Status last verified
- Feb 2020
- First submitted
- 26 Jan 2018
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the VisuMax Femtosecond Laser Lenticule Removal Procedure for the Correction of Hyperopia With or Without Astigmatism
- ClinicalTrials.gov ID
- NCT03431571
- Acronym / sponsor ID
- V1601CI / V1601CI
- Conditions
- Hypermetropia
- Keywords
- ReLEx, SMILE, Hyperopia, VisuMax, Small Incision Lenticule Extraction, Lenticule, Farsightedness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 13 Feb 2018 (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 correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation. The objective is to evaluate the safety and effectiveness.
Detailed description
The VisuMax laser keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax laser keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused, ultra-short pulses, delivered through a disposable applanation lens while fixating the eye under a low vacuum. ReLEx SMILE combines state-of-the-art femtosecond laser technology of the VisuMax with high-precision lenticule extraction to provide minimally invasive refractive correction. It is distinguished by its flapless, minimally invasive laser correction. A refractive lenticule is created in the intact cornea, but removed via a small incision. The changed form of the cornea corrects the refraction error. ReLEx SMILE for myopia is a well-established treatment with extensive supporting published evidence for efficacy and safety. It is CE marked and available since 2011; more than 1 Million procedures have been performed worldwide. The correction of farsightedness using ReLEx SMILE for hyperopia is focus of this investigation and is therefore not yet CE marked.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Procedure: ReLEx SMILEReLEx SMILE treatment can be done binocular or monocular, no masking and randomization used, no control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Normal corneal topography;
- Predicted post-operative keratometry ≤51 D;
- Contact lens wearers must stop wearing their contact lenses before baseline measurements according to local requirements of the clinic;
- Patients should be able to understand the patient information and willing to sign an informed consent;
- Patients should be willing to comply with all follow-up visits and the respective examinations;
Key exclusion criteria (3 listed)
- The patients presenting at least one of the characteristics as described for exclusion criteria in the documentation set of the VisuMax laser keratome ReLEx SMILE option.
- Mixed astigmatism
- Any impaired person (minors, pregnant or breast feeding women or persons incapable of giving consent) are definitely excluded from the study.
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 |
|---|---|---|
| ReLEx SMILEthe VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea | Procedure or surgery | Single arm |
Primary outcome
Corrected Distance Visual Acuity (CDVA)
Time frame: 12 months
CDVA in logMar
5 secondary outcomes
side effects
Time frame: 12 months
contrast sensitivity
Time frame: 12 months
patient satisfaction (Quality of Vision Questionnaire)
Time frame: 12 months
manifest refractive astigmatism
Time frame: 12 months
spherical equivalent (SE)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Walter Sekundo principal investigator
Uniklinikum Gießen Marburg
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReLEx SMILE in people with Hypermetropia, run by Carl Zeiss Meditec AG at 8 sites in 6 countries.
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 3 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China, Germany, Czechia, France, India and 1 more country. 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?
Results are not available in the source record.
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?
Corrected Distance Visual Acuity (CDVA) (time frame: 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 24 Feb 2020.