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Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism

Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03538964
Acronym
Low Asti
Enrollment
25
Registered
2018-05-29
Start date
2018-05-02
Completion date
2020-08-01
Last updated
2019-10-02

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

Conditions

Astigmatism, Cataract

Keywords

Cataract, Low Astigmatism

Brief summary

Comparison of the astigmatism reducing effect of a toric IOL with a non toric IOL in eyes with low corneal astigmatism.

Detailed description

With increasing demands of patients concerning refractive outcome after cataract surgery, toric intraocular lenses (IOLs) that correct corneal astigmatism have been introduced more widely to cataract surgery. Originally, toric IOLs were used mainly for patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate amounts of astigmatism which are much more prevalent with about 8% having a corneal astigmatism of 2.0D or more in the cataract population. 5Using toric IOLs for these eyes results in less spectacle dependence of patients due to the astigmatic correction. Other astigmatism reducing techniques, such as peripheral corneal relaxing incisions and opposite clear corneal incisions were shown to be less predictable. Although the use of toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery , there is still uncertainty, if low astigmatism should be corrected. Visser et al. showed that moderate astigmatism of than 1.5D should be corrected for monofocal IOLs and Hayashi showed that remaining astigmatism of 1.0D already decreases visual quality in eyes with multifocal IOLs. Although correction of low corneal astigmatism appears to be beneficial, some hurdles have to be taken into account. In eyes with low corneal astigmatism the accuracy of measuring the astigmatism meridian is relatively low. Furthermore, different corneal measurement techniques are not always comparable and it is difficult to know, which device shows the correct amount of astigmatism. Additionally, the correction of the spherical equivalent is of high importance, as a refractive surprise will also attenuate the astigmatism reducing effect of the toric IOL. Aim of this study is to assess, if toric IOLs are useful in patients with low amounts of corneal astigmatism and to quantify the sources of error in toric IOL power calculation.

Interventions

cataract surgery with implantation of an toric intraocular lens

PROCEDUREnon toric intraocular lens

cataract surgery with implantation of a non toric intraocular lens

Sponsors

Prim. Prof. Dr. Oliver Findl, MBA
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* cataract * Age 21 and older * Regular corneal astigmatism 0.5D up to 1.5 D and difference between eyes not more than 0.75D * written informed consent prior to surgery

Exclusion criteria

* relevant other ophthalmic diseases such as: pseudoexfoliation, glaucoma, traumatic cataract corneal scars, and other co-morbidity that could affect capsule bag stability ( e.g. Marfan syndrome) * Irregular corneal astigmatism on corneal topography * In case of pregnancy (pregnancy test will be taken preoperatively in women of reproductive age)

Design outcomes

Primary

MeasureTime frame
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups12 months

Secondary

MeasureTime frameDescription
Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)12 months
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens12 months
Wavefront analysis of high order aberrations (root mean square, in microns)12 months
Questionnaire to asses patients subjective satisfaction with visual outcome12 monthsIn the questionnaire the patient has to choose if different tasks (e.g. reading, driving, watching TV) are easier for him/ her with the right eye, the left eye, or if there is no difference between both eyes

Countries

Austria

Contacts

Primary ContactJulius Hienert, MD
j.hienert@viros.at+43 01 91021 57564
Backup ContactNino Hirnschall, MD
nino.hirnschall@googlemail.com+43 01 91021 57564

Outcome results

None listed

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