Clinical trial NCT06978556: Photopic and Mesopic Multifocal IOL Performance
Official title: Comparison of Lens Position and Photopic and Mesopic Visual Acuity After Bilateral Implantation of Two Different Diffractive Multifocal Intraocular Lenses.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cataract
Presbyopia Correction
Keywords: Cataract
multifocal iol
presbyopia
reading speed
Lead sponsor: IROC AG
Sponsor class: OTHER
Collaborators: name: AMO Ireland
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing cataract surgery with multifocal IOL implantation at the study site fulfilling inclusion criteria will be asked to participate in the study. All patients are referred by ophthalmologists or are self-referrals at the study site.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: IOL axial position stability
timeFrame: 1, 3, 6, 12 months
Secondary outcomes:
measure: refraction
timeFrame: 1, 3, 6, 12 months
measure: Visual acuity
timeFrame: 1, 3, 6, 12 months
measure: Reading speed
timeFrame: 3 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: IROC
Study officials:
affiliation: IROC AG
name: Theo Seiler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benyoussef AA, Reboux N, Cochener B. Comparison of Bilateral Reading Performance Among Two Presbyopia-Correcting Intraocular Lenses. J Refract Surg. 2022 Jul;38(7):428-434. doi: 10.3928/1081597X-20220516-02. Epub 2022 Jul 1.
citation: Seiler TG, Wegner A, Senfft T, Seiler T. Dissatisfaction After Trifocal IOL Implantation and Its Improvement by Selective Wavefront-Guided LASIK. J Refract Surg. 2019 Jun 1;35(6):346-352. doi: 10.3928/1081597X-20190510-02.
citation: Cillino G, Casuccio A, Pasti M, Bono V, Mencucci R, Cillino S. Working-age cataract patients: visual results, reading performance, and quality of life with three diffractive multifocal intraocular lenses. Ophthalmology. 2014 Jan;121(1):34-44. doi: 10.1016/j.ophtha.2013.06.034. Epub 2013 Aug 14.
citation: Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J Cataract Refract Surg. 2015 Feb;41(2):354-63. doi: 10.1016/j.jcrs.2014.05.048.
citation: Martinez-de-la-Casa JM, Carballo-Alvarez J, Garcia-Bella J, Vazquez-Molini JM, Morales L, Sanz-Fernandez JC, Polo V, Garcia-Feijoo J. Photopic and Mesopic Performance of 2 Different Trifocal Diffractive Intraocular Lenses. Eur J Ophthalmol. 2017 Jan/Feb;27(1):26-30. doi: 10.5301/ejo.5000814.
citation: Alio JL, Kaymak H, Breyer D, Cochener B, Plaza-Puche AB. Quality of life related variables measured for three multifocal diffractive intraocular lenses: a prospective randomised clinical trial. Clin Exp Ophthalmol. 2018 May;46(4):380-388. doi: 10.1111/ceo.13084. Epub 2017 Nov 29.
citation: Portney V. Light distribution in diffractive multifocal optics and its optimization. J Cataract Refract Surg. 2011 Nov;37(11):2053-9. doi: 10.1016/j.jcrs.2011.04.038.
citation: Hienert J, Hirnschall N, Ruiss M, Ullrich M, Zwickl H, Findl O. Prospective study to compare axial position stability after fellow-eye implantation of 2 distinct intraocular lens designs. J Cataract Refract Surg. 2021 Aug 1;47(8):999-1005. doi: 10.1097/j.jcrs.0000000000000557.