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

Prim. Prof. Dr. Oliver Findl, MBA

Status: Unknown

Conditions: Cataract; Astigmatism

Treatments: Procedure: non toric intraocular lens; Procedure: toric intraocular lens

Study type: Interventional

Funder types: Other

Identifiers

NCT03538964

Low Asti

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Toric intraocular lens (IOL)

Active Comparator group

Description:

toric intraocular lens for low astigmatism correction

Treatment:

Procedure: toric intraocular lens

Non toric intraocular lens (IOL)

Sham Comparator group

Description:

non toric intraocular lens

Treatment:

Procedure: non toric intraocular lens