Health TrialsbyHealthPanel

Measuring Outcomes of LASIK and EVO-ICL in Matched Populations

ConditionMyopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-45
SponsorVance Thompson Vision

About this trial

Evaluating outcomes after bilateral implantation of ICLs or bilateral LASIK as treatment options for the correction or reduction of myopia with or without astigmatism.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects ages 21 to 45 years old.

Stable refractive error for at least one year (≤ 0.50 D change in refraction) or stability as determined by the Investigator.

Myopia or myopia with astigmatism with spherical equivalent ranging from -3.00 D to ≤ -8.00 D (in the spectacle plane) and cylinder in the range of 0.00 D to 4.00 D (in the spectacle plane).

Corrected distance visual acuity (CDVA) of 20/20 or better in each eye.

Disqualifiers

1. Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study or has another condition with associated fluctuation of hormones that could lead to refractive changes.

Pigment dispersion,

History or clinical signs of iritis/uveitis,

History of previous ocular surgery,

Trial design

Design model

Single group

Treatments tested in this trial

  • Laser-assisted in Situ Keratomileusis

    Device

    LASIK

  • Implantable Collamer Lens placement

    Device

    EVO ICL

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Laser-assisted in Situ KeratomileusisActive comparator 1 intervention
Group B: Implantable Collamer Lens placementActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Acuity

Uncorrected distance visual acuity and Corrected distance visual acuity

Time frame
1 month
2

Manifest refractive spherical equivalent

Manifest refraction spherical equivalent (MRSE) is a measurement used in eye care to determine the overall refractive error of the eye, taking into account both nearsightedness or farsightedness (spherical component) and astigmatism (cylindrical component). It's calculated by adding the sphere power and half of the cylinder power

Time frame
1 month
3

Abberometry (Higher Order Abberations and Corneal Performance Index)

Aberrometry is a technique used to measure the optical aberrations of the eye, including both lower-order aberrations (LOAs) and higher-order aberrations (HOAs). LOAs are the standard refractive errors, such as nearsightedness, farsightedness, and astigmatism, which can be corrected with glasses or contact lenses. HOAs, on the other hand, are more complex aberrations that affect the quality of vision, even if the LOAs are corrected. HOAs are caused by irregularities in the shape of the cornea or lens. They can cause a variety of visual symptoms, including blurry vision, glare, halos, and difficulty seeing at night

Time frame
1 month
4

Objective Scatter Index

The Objective Scatter Index (OSI) is a measurement used in ophthalmology to assess the quality of the eye's optical media, particularly the cornea and lens. It quantifies the amount of light scatter within the eye, which can affect visual clarity and contrast sensitivity.

Time frame
1 month

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vance Thompson Vision

Lead sponsor

Source ClinicalTrials.gov
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