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Photopic and Mesopic Multifocal IOL Performance

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06978556
Acronym
MIOLRead
Enrollment
60
Registered
2025-05-18
Start date
2023-01-01
Completion date
2025-06-30
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract, Presbyopia Correction

Keywords

Cataract, multifocal iol, presbyopia, reading speed

Brief summary

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.

Interventions

DIAGNOSTIC_TESTNo intervention is subject of the study. Only standard pre- and postoperative data will be evaluated.

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.

Sponsors

AMO Ireland
CollaboratorUNKNOWN
IROC AG
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Male and female subjects age 45 years of age and older 2. Able to provide written informed consent and follow study instructions in English or German. 3. Desire for spectacle independence 4. Agreement on clinical decision for planned crystalline lens exchange with multifocal IOL implantation (Standardized femtosecond-laser capsulotomy (diameter 5.3mm)) 5. Willing and able to return for scheduled follow-up examinations;

Exclusion criteria

1. Prior ophthalmic surgery or trauma 2. Zonular-defects, unstable bag 3. Macular pathologies 4. Excessive irregular astigmatism 6\. 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;

Design outcomes

Primary

MeasureTime frameDescription
IOL axial position stability1, 3, 6, 12 monthsas measured with a biometry and/or anterior segment device.

Secondary

MeasureTime frameDescription
refraction1, 3, 6, 12 monthsstandardized ETDRS charts Optometrist blinded
Visual acuity1, 3, 6, 12 monthsStandardized with ETDRS charts for far, intermediate, and far distance visual acuity. Defocus curve. Optometris is blinded. Measurement in photopic and mesopic conditions
Reading speed3 monthsstandardized with iRest test. In photopic and mesopic conditions. optometrist is blinded.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026