MyopiaNCT05684237
Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration
A study testing HiSMILE treatment option in people with Myopia and Myopic Astigmatism, run by London Vision Clinic at 1 site in United Kingdom.
Trial summary
The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia, Myopic Astigmatism, Presbyopia
- What is being tested?
- HiSMILE treatment option
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2023to Feb 2026
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fulfillment of the general inclusion criteria stated in User Manual of the VisuMax option SMILE
- Presence of myopia up to -10.00 D with or without astigmatism up to 5.00 D and a maximum spherical equivalent of -12.50 D (SMILE CE approved range)
- Age of 40 years or older
- Presence of presbyopia
- Patients able to receive a refractive correction in both eyes and in addition a compensation of presbyopia, in which one eye should be targeted for far vision and one eye should be targeted for near vision
- Pre-operative CDVA of 20/25 or better in each eye as well as a Distance Corrected Near Visual Acuity (DCNVA) of 20/25 (J2) or worse
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- Target refraction of the near eye between -0.50 D to -1.75 D
- Acceptance of anisometropia (no visual discomfort or disturbances during the Acceptance Test before surgery, eye intended for near vision determined during this test)
- Compliance with follow-up visits and examinations
Who cannot join
- Presence of at least one of the contraindications stated in the User Manual of the VisuMax option SMILE or in the Surgical Information Package provided to the patient by the London Vision Clinic before surgery
- Hyperopic refraction
- Mixed astigmatism refraction
- Emmetropic eyes, defined as spherical equivalent refraction <-0.88 D, maximum hyperopia ≤+1.00 D and cylinder <1.25 D
- Patients presenting any kind of amblyopia
- Previous intraocular or corneal surgery
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- Participation in other ophthalmologic or pharmaceutical studies
- Women during pregnancy and/or lactation
- Patients whose freedom is impaired by administrative or legal order
- Persons incapable of giving consent
Trial locations and contacts
1 site in 1 country.
About this study
The intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.
Read the detailed description
Presbyopia refers to an impairment of near vision that is common among adults over 40 years of age. It is known to considerably decrease quality of life, especially given the heavy use of computers and smartphones. The management of presbyopia can be divided into non-surgical approaches, such as glasses and contact lenses, and surgical approaches.
A refractive surgical approach to treating presbyopia was developed by Reinstein et al termed PRESBYOND® Laser Blended Vision. PRESBYOND® is different from traditional monovision (when the dominant eye is mainly corrected for distance and the non-dominant eye is mainly corrected for near) because it increases the depth of field as a result, a blend zone is created, which allows the patient to see near, intermediate and far without glasses
Following its introduction in 2011, surgical approaches such as small incision lenticule extraction (SMILE) are increasing in popularity due to the high level of safety, efficacy and other advantages. Compared to laser-assisted in situ keratomileusis (LASIK), SMILE preserves more corneal nerves and better maintains the strength of the cornea. Worldwide more than 6 million SMILE procedures have been performed.
SMILE has also been combined with monovision as a treatment option for presbyopic patients. First results of SMILE monovision in patients with presbyopia and short-sightedness (myopia) have been published showing promising outcomes for distance and near vision. However, those investigations noted SMILE did not increase the depth of field, and as a result outcomes for vision at the intermediate (computer) distance did not reach the level as those achieved with PRESBYOND LASIK.
Therefore, a new treatment option called HiSMILE was developed to improve the depth of field and therefore the intermediate vision. A clinical study is required to investigate whether the HiSMILE treatment option can alter the depth of field for different levels of short-sightedness to achieve the required levels without compromise to contrast sensitivity or quality of vision.
- Conditions
- Myopia, Myopic Astigmatism, Presbyopia
- Being tested
- HiSMILE treatment option
- Medical subject headings
- Myopia, Astigmatism, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiSMILE treatment optionProcedure or surgery
The non-CE labeled VisuMax treatment option HiSMILE is able to modify the lenticule shape in a way that should lead to a change in spherical aberration postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| HiSMILE treatment option | Other | HiSMILE treatment option Receives: Procedure: HiSMILE treatment option |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance
Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 3 months.
Measured: 3 Months
Performance
Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 12 months.
Measured: 12 Months
Safety Outcome
Percentage of eyes with loss of 2 lines (10 letters) or more of Corrected Distance Visual Acuity (CDVA) at 3 months postoperative compared to the baseline visit
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 posted13 Jan 2023
- Study start13 Oct 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Vision Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Reinstein, London Vision Clinic
- Investigators
- Dan Reinstein, Principal investigator, London Vision Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684237
- Sponsor's protocol ID
- LoVC-010
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2022
- Last updated
- 18 Oct 2023
- Results posted
- No
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the VisuMax Femtosecond Laser System to Perform SMILE Optimized for Presbyopia by Modulation of Postoperative Spherical Aberration
- ClinicalTrials.gov ID
- NCT05684237
- Acronym / sponsor ID
- LoVC-010
- Conditions
- Myopia, Myopic Astigmatism, Presbyopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- London Vision ClinicUniversity, hospital or other
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 13 Jan 2023 (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 intended purpose of the investigational device in the study is the correction of myopia and myopia with astigmatism in the CE (Conformité Européene) approved range and optimized for presbyopic patients using the treatment option HiSMILE, installed on the VisuMax femtosecond laser.
Detailed description
Presbyopia refers to an impairment of near vision that is common among adults over 40 years of age. It is known to considerably decrease quality of life, especially given the heavy use of computers and smartphones. The management of presbyopia can be divided into non-surgical approaches, such as glasses and contact lenses, and surgical approaches.
A refractive surgical approach to treating presbyopia was developed by Reinstein et al termed PRESBYOND® Laser Blended Vision. PRESBYOND® is different from traditional monovision (when the dominant eye is mainly corrected for distance and the non-dominant eye is mainly corrected for near) because it increases the depth of field as a result, a blend zone is created, which allows the patient to see near, intermediate and far without glasses
Following its introduction in 2011, surgical approaches such as small incision lenticule extraction (SMILE) are increasing in popularity due to the high level of safety, efficacy and other advantages. Compared to laser-assisted in situ keratomileusis (LASIK), SMILE preserves more corneal nerves and better maintains the strength of the cornea. Worldwide more than 6 million SMILE procedures have been performed.
SMILE has also been combined with monovision as a treatment option for presbyopic patients. First results of SMILE monovision in patients with presbyopia and short-sightedness (myopia) have been published showing promising outcomes for distance and near vision. However, those investigations noted SMILE did not increase the depth of field, and as a result outcomes for vision at the intermediate (computer) distance did not reach the level as those achieved with PRESBYOND LASIK.
Therefore, a new treatment option called HiSMILE was developed to improve the depth of field and therefore the intermediate vision. A clinical study is required to investigate whether the HiSMILE treatment option can alter the depth of field for different levels of short-sightedness to achieve the required levels without compromise to contrast sensitivity or quality of vision.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HiSMILE treatment option | Other | Procedure: HiSMILE treatment optionHiSMILE treatment option |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Fulfillment of the general inclusion criteria stated in User Manual of the VisuMax option SMILE
- Presence of myopia up to -10.00 D with or without astigmatism up to 5.00 D and a maximum spherical equivalent of -12.50 D (SMILE CE approved range)
- Age of 40 years or older
- Presence of presbyopia
- Patients able to receive a refractive correction in both eyes and in addition a compensation of presbyopia, in which one eye should be targeted for far vision and one eye should be targeted for near vision
Key exclusion criteria (10 listed)
- Presence of at least one of the contraindications stated in the User Manual of the VisuMax option SMILE or in the Surgical Information Package provided to the patient by the London Vision Clinic before surgery
- Hyperopic refraction
- Mixed astigmatism refraction
- Emmetropic eyes, defined as spherical equivalent refraction <-0.88 D, maximum hyperopia ≤+1.00 D and cylinder <1.25 D
- Patients presenting any kind of amblyopia
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 |
|---|---|---|
| HiSMILE treatment optionThe non-CE labeled VisuMax treatment option HiSMILE is able to modify the lenticule shape in a way that should lead to a change in spherical aberration postoperatively. | Procedure or surgery | HiSMILE treatment option |
Primary outcome
Performance
Time frame: 3 Months
Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 3 months.
Performance
Time frame: 12 Months
Percentage of eyes with ocular spherical aberration within the therapeutic range of 0.3 to 0.6 μm (Optical Society of America notation at 6 mm analysis diameter) at 12 months.
Safety Outcome
Time frame: 3 Months
Percentage of eyes with loss of 2 lines (10 letters) or more of Corrected Distance Visual Acuity (CDVA) at 3 months postoperative compared to the baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- 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.
Dan Reinstein principal investigator
London Vision Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HiSMILE treatment option in people with Myopia and Myopic Astigmatism, run by London Vision Clinic at 1 site in United Kingdom.
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 9 inclusion and 10 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 18 Oct 2023. 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 United Kingdom. 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?
Performance (time frame: 3 Months). The study lists 3 primary outcomes in all. 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 18 Oct 2023.