Virtual Eye Model System for Personalised Refractive Surgery Treatment

NCT05551715 | Completed

• 1 other identifier: VEMoS
• Study Type: interventional
• Target: 547
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Redesign VEMoS software
2. 2.Determine which biometric data, diagnostic tools, and objective and subjective metrics of visual quality are best for the selection of optimal refractive parameters for surgery
3. 3.Optimize the combined use of biometric data, VEMoS software, and visual quality metrics Study design The proposed multicenter clinical trial is observational and prospective. There will be three arms within the clinical trial, a no-treatment arm, a refractive surgery arm, and a cataract surgery arm. Participants in the untreated arm will undergo an ophthalmic exam only once. Participants in the other two arms will undergo two ophthalmic exams, one before and one after surgery. For all participants, cataract or refractive surgery will be performed as part of routine clinical practice. Other additional tests performed are all non-invasive.

Conditions

Individualized Refractive Surgery

Outcome Measures

Primary Outcomes (5)

• Variables to run the VEMoS software and obtain estimates and simulations Corneal Topography

  To evaluate the keratomery in diopters

  3 months

• Variables to run the VEMoS software and obtain estimates and simulations Pupil size

  To evaluate pupil size at different illumination in milimeters

  3 months

• Variables to run the VEMoS software and obtain estimates and simulations anterior chamber depth

  To obtain the anterior chamber depth in milimeters

  3 months

• Variables to run the VEMoS software and obtain estimates and simulations, crystalline lens thickness

  To obtain the crystalline lens thickness in milimeters

  3 months

• Variables to run the VEMoS software and obtain estimates and simulations, axial length

  To obtain the axial length in milimeters

  3 months

Study Arms (3)

Untreated eyes

OTHER

Participants in the untreated arm will undergo an ophthalmic examination only once.

Device: Software development for individualized refractive surgery

Refractive surgery

OTHER

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

Cataract surgery

OTHER

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

Interventions

Software development for individualized refractive surgery DEVICE

Software development for individualized refractive surgery

Cataract surgery; Refractive surgery; Untreated eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients from 18 to 40 years of age and with less than 2 D of astigmatism.
• for LASIK: sphere between -10 D and +4 D and with less than 3 D of astigmatism.
• for SMILE: sphere between -10 D and -3 D, with less than 3 D of astigmatism.
• patients older than 50 years old without any active ocular pathologies affecting visual capabilities except cataract and with less than 1 D of astigmatism.

You may not qualify if:

• ocular pathology affecting visual capabilities,
• reduced transparency of ocular media,
• systemic disease affecting visual capabilities.
• Systemic disease affecting visual capabilities.
• Ocular pathology affecting visual capabilities other than cataract
• Included patients will be excluded if surgical complications occurs

Sponsors & Collaborators

• Vissum, Instituto Oftalmológico de Alicante: lead
• COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL: collaborator
• Unidade Local de Saúde de Coimbra, EPE: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Alicante Vissum Miranza

Alicante, Alicante, 03016, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 23, 2022
• Study Start: April 20, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)