Virtual Eye Model System for Personalised Refractive Surgery 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:

1. Redesign VEMoS software
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. 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.

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).

Study Overview

• Status: Completed
• Conditions: Individualized Refractive Surgery
• Intervention / Treatment: Device: Software development for individualized refractive surgery

• Study Type: Interventional
• Enrollment (Actual): 547
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Alicante Vissum Miranza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For the untreated eyes arm, the inclusion criterion is:

• patients from 18 to 40 years of age and with less than 2 D of astigmatism.

For the refractive surgery arm, the inclusion criteria are:

• 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.

For the cataract surgery arm, the inclusion criterion is:

• patients older than 50 years old without any active ocular pathologies affecting visual capabilities except cataract and with less than 1 D of astigmatism.

Exclusion Criteria:

For the untreated eyes and the refractive surgery arms, the exclusion criteria are:

• ocular pathology affecting visual capabilities,
• reduced transparency of ocular media,
• systemic disease affecting visual capabilities.

For the cataract surgery arms, the exclusion criterion is:

• Systemic disease affecting visual capabilities.
• Ocular pathology affecting visual capabilities other than cataract
• Included patients will be excluded if surgical complications occurs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Untreated eyes; Participants in the untreated arm will undergo an ophthalmic examination only once.	Device: Software development for individualized refractive surgery; Software development for individualized refractive surgery
Other: 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; Software development for individualized refractive surgery
Other: Cataract 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vissum, Instituto Oftalmológico de Alicante
• Collaborators: Aarhus University Hospital; Centro Hospitalar e Universitário de Coimbra, E.P.E.; COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: September 13, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: VEMoS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No