An interventional study of HiSMILE treatment option in Myopia, Myopic Astigmatism and Presbyopia, sponsored by London Vision Clinic. Enrolling by invitation at 1 site in United Kingdom. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by London Vision Clinic · Not applicable, Interventional, and Treatment
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.
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 53 is below the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →London Vision Clinic is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HiSMILE treatment option
Procedure: HiSMILE treatment option
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.
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.
Time frame: 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.
Time frame: 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
Time frame: 3 Months
Plan to share: No
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