Visumax Femtosecond Laser to Perform SMILE Optimized For Presbyopia
Research type
Research Study
Full title
USING THE VISUMAX FEMTOSECOND LASER SYSTEM TO PERFORM SMILE OPTIMIZED FOR PRESBYOPIA BY MODULATION OF POSTOPERATIVE SPHERICAL ABERRATION
IRAS ID
321771
Contact name
Dan Reinstein
Contact email
Sponsor organisation
London Vision Clinic
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
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 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.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0097
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion