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NCT Number: NCT06978556

Photopic and Mesopic Multifocal IOL Performance

Modern cataract surgery has become a refractive procedure. Both, multifocal lens implantation and pseudophakic monovision with monofocal IOLs are effective means to address presbyopia correction after cataract surgery. Historically, diffractive multifocal IOLs have provided improved visual acuity at near and intermediate distances and a greater likelihood of spectacle independence than monofocal IOLs.

The light transmittance ratio of the crystalline lens is high and as a monofocal ocular medium that has the ability to modify its shape and geometric properties according to the focal point. Therefore, it is capable of delivering the exact same light energy to the retina, regardless of the distance of the object. Trifocal IOL designs split the light in three focal points. By varying the height of the diffractive step, the amount of light distributed to near, intermediate and distant foci is adjusted according to pupil aperture. The distribution of light to three different foci includes several potential disadvantages, such as loss of visual acuity in mesopic conditions and a loss of contrast sensitivity. Thus, the visual performance of multifocal IOLs depends on several factors, the addition (add) power is a major determinant of the actual range of clear vision, another factor is the light transmittance characteristics of the lens (e.g., the incorporation of a blue light filter).

As different trifocal IOLs become available, it is important to have information on their characteristics regarding visual acuity in order to be able to recommend an IOL that meets the individualized needs of each patient. In order to provide the patient with a high visual acuity in all promised distances, these IOLs need to be aimed at and achieve emmetropia.

Furthermore, multifocal IOLs need good capsular bag centration, they need to remain as unaffected as possible by capsular bag constriction and remain stable in their axial lens position in order to provide a stable refraction after surgery.

The investigators compare the anterior chamber depth stability as marker for positional stability and haptic buckling between two different diffractive IOL designs, one with C-loop haptics and one with plate haptics. Furthermore, the refractive outcome of these IOLs with different designs is examined in photopic and mesopic conditions, as well as visual acuity results for both IOLs.

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This study is active but is not currently recruiting participants.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IROC

Zurich, Canton of Zurich, 8002, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female subjects age 45 years of age and older
  • Able to provide written informed consent and follow study instructions in English or German.
  • Desire for spectacle independence
  • Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm))
  • Willing and able to return for scheduled follow-up examinations;

Exclusion criteria

  • Prior ophthalmic surgery or trauma
  • Zonular-defects, unstable bag
  • Macular pathologies
  • Excessive irregular astigmatism
  • Pregnancy/lactation 7. Predicted Visual acuity of less than 0.8 decimal 8. Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;

Treatment and study plan

No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.

Diagnostic Test

No intervention is subject of the study. Only standard pre- and postoperative data will be evaluated. Including data from testing refraction, visual acuity, biometry, tomography, and OCT.

Primary outcomes

  1. IOL axial position stability

    Time frame: 1, 3, 6, 12 months

    as measured with a biometry and/or anterior segment device.

Secondary outcomes

  1. refraction

    Time frame: 1, 3, 6, 12 months

    standardized ETDRS charts Optometrist blinded

  2. Visual acuity

    Time frame: 1, 3, 6, 12 months

    Standardized with ETDRS charts for far, intermediate, and far distance visual acuity. Defocus curve.

    Optometris is blinded. Measurement in photopic and mesopic conditions

  3. Reading speed

    Time frame: 3 months

    standardized with iRest test. In photopic and mesopic conditions.

    optometrist is blinded.

Sponsors and collaborators

Lead sponsor

IROC AG

Other

Collaborators

  • AMO Ireland

Registry information

Official study title

Comparison of Lens Position and Photopic and Mesopic Visual Acuity After Bilateral Implantation of Two Different Diffractive Multifocal Intraocular Lenses.

Acronym: MIOLRead

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 18, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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