Virtual Eye Model System for Personalised Refractive Surgery Treatment

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. 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).

Conditions

• Individualized Refractive Surgery

Interventions

DEVICE

Software development for individualized refractive surgery

Software development for individualized refractive surgery

Sponsors & Collaborators

• COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

  collaborator UNKNOWN

• Unidade Local de Saúde de Coimbra, EPE

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Vissum, Instituto Oftalmológico de Alicante

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-04-20

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• Spain

Study Locations