An interventional study of Software development for individualized refractive surgery in Individualized Refractive Surgery, sponsored by Vissum, Instituto Oftalmológico de Alicante. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by Vissum, Instituto Oftalmológico de Alicante · Not applicable, Interventional, and Treatment
Justification: Although great strides have been made in the past to develop VEMoS software, it has not yet been validated with actual clinical data from patients who have undergone cataract or refractive surgery.
There are some fundamental questions that must be addressed to validate and update the software, such as the objective visual quality metrics that best predict the patient's post-surgical subjective vision from the predictions of the optical properties of the eye.
The VEMoS software must be adjusted for different types of inputs and eye parameters:
Corneal tomography of MS39-AXL MS39-AXL corneal tomography + biometric data from the IOL Master MS39-AXL corneal tomography + IOL Master biometric data + total aberrometry Combinations of any of the above with the optical properties of a specific IOL, etc.
Objective The main objective is to standardize the selection of parameters to personalize refractive surgery, based on the biometric data of each patient.
The objectives necessary to achieve such an ambitious goal are:
Study population Untreated eye arm patients 18 to 40 years of age. Refractive surgery arm patients who are planned and have consented to a corneal refractive procedure to gain spectacle independence.
Cataract surgery arm patients older than 50 years who are planned and have consented to cataract surgery.
Sample size The sample sizes for each arm of the clinical trial are as follows.
Untreated eye arm:
The goal is to recruit 600 eyes from 300 patients, 100 patients in each of these groups:
Myopia (from -10 D to -0.75 D) Emmetropia (from -0.5 D to + 0.5 D) Hyperopia (from 0.75 D to 5 D)
Refractive surgery arm:
For LASIK, the goal is to recruit 800 eyes from 400 patients, 100 patients in each of these groups:
High myopia (from -10 D to -6 D) Medium myopia (from -6 D to -3 D) Low myopia (from -3 D to -1 D) Hyperopia (from +1 D to +4 D)
For SMILE, the goal is to recruit 400 eyes from 200 patients, 100 patients in each of these groups:
High myopia (from -10 D to -6 D) Average myopia (from -6 D to -3 D)
For the cataract surgery arm:
The goal is to recruit 400 eyes from 200 patients, 100 patients in each of these groups Zeiss monofocal IOLs multifocal IOL
A total of 500 patients are expected between the Vissum, IMO and IOA clinics in Miranza.
A total of 250 patients are expected between hospital and university of Coimbra epe (Portugal).
A total of 350 patients are expected at Aarhus universitetshospital (Denmark).
Vissum, Instituto Oftalmológico de Alicante is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For the untreated eyes arm, the inclusion criterion is:
For the refractive surgery arm, the inclusion criteria are:
For the cataract surgery arm, the inclusion criterion is:
Exclusion Criteria:
For the untreated eyes and the refractive surgery arms, the exclusion criteria are:
For the cataract surgery arms, the exclusion criterion is:
Participants in the untreated arm will undergo an ophthalmic examination only once.
Device: Software development for individualized refractive surgery
Participants on this arm will undergo two ophthalmic examinations, one before and one after surgery. For refractive surgery participants, refractive surgery will be performed as part of the habitual clinical practice. All other additional tests performed as part of the clinical trial are all non-invasive.
Device: Software development for individualized refractive surgery
Participants on this arm will undergo two ophthalmic examinations, one before and one after surgery. For cataract surgery participants, cataract surgery will be performed as part of the habitual clinical practice. All other additional tests performed as part of the clinical trial are all non-invasive.
Device: Software development for individualized refractive surgery
Software development for individualized refractive surgery
Variables to run the VEMoS software and obtain estimates and simulations Corneal Topography
To evaluate the keratomery in diopters
Time frame: 3 months
Variables to run the VEMoS software and obtain estimates and simulations Pupil size
To evaluate pupil size at different illumination in milimeters
Time frame: 3 months
Variables to run the VEMoS software and obtain estimates and simulations anterior chamber depth
To obtain the anterior chamber depth in milimeters
Time frame: 3 months
Variables to run the VEMoS software and obtain estimates and simulations, crystalline lens thickness
To obtain the crystalline lens thickness in milimeters
Time frame: 3 months
Variables to run the VEMoS software and obtain estimates and simulations, axial length
To obtain the axial length in milimeters
Time frame: 3 months
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Vissum, Instituto Oftalmológico de Alicante