Photopic and Mesopic Multifocal IOL Performance

Active, not recruiting

• Conditions: Cataract; Presbyopia Correction

• Registration Number: NCT06978556
• Lead Sponsor: IROC AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-11
• Study First Submitted QC: 2025-05-11
• Study First Posted: 2025-05-18
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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

5. 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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOL axial position stability	1, 3, 6, 12 months	as measured with a biometry and/or anterior segment device.

Secondary Outcome Measures

Name	Time	Method
Visual acuity	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
Reading speed	3 months	standardized with iRest test. In photopic and mesopic conditions.; optometrist is blinded.
refraction	1, 3, 6, 12 months	standardized ETDRS charts Optometrist blinded

Trial Locations

Locations (1)

IROC; 🇨🇭 Zürich, Switzerland