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Trial record 11 of 103 for:    cataract AND Astigmatism

Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism (Low Asti)

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ClinicalTrials.gov Identifier: NCT03538964
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Information provided by (Responsible Party):
Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery

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

Condition or disease Intervention/treatment Phase
Cataract Astigmatism Procedure: toric intraocular lens Procedure: non toric intraocular lens Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
Actual Study Start Date : May 2, 2018
Estimated Primary Completion Date : May 2, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: Toric intraocular lens (IOL)
toric intraocular lens for low astigmatism correction
Procedure: toric intraocular lens
cataract surgery with implantation of an toric intraocular lens

Sham Comparator: Non toric intraocular lens (IOL)
non toric intraocular lens
Procedure: non toric intraocular lens
cataract surgery with implantation of a non toric intraocular lens




Primary Outcome Measures :
  1. Subjective refraction to detect remaining astigmatism (in Diopters) between both groups [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees) [ Time Frame: 12 months ]
  2. Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens [ Time Frame: 12 months ]
  3. Wavefront analysis of high order aberrations (root mean square, in microns) [ Time Frame: 12 months ]
  4. Questionnaire to asses patients subjective satisfaction with visual outcome [ Time Frame: 12 months ]
    In 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



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538964


Contacts
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Contact: Julius Hienert, MD +43 01 91021 57564 j.hienert@viros.at
Contact: Nino Hirnschall, MD +43 01 91021 57564 nino.hirnschall@googlemail.com

Locations
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Austria
Vienna Institute for Research in Ocular Surgery (VIROS) Recruiting
Vienna, Austria, 1140
Contact: Julius Hienert, MD    01 90121-57564    j.hienert@viros.at   
Contact: Nino Hirnschall, MD    01 90121-57564    nino.hirnschall@wgkk.at   
Sponsors and Collaborators
Prim. Prof. Dr. Oliver Findl, MBA

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Responsible Party: Prim. Prof. Dr. Oliver Findl, MBA, Principal Investigator, Vienna Institute for Research in Ocular Surgery
ClinicalTrials.gov Identifier: NCT03538964     History of Changes
Other Study ID Numbers: Low Asti
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery:
Cataract
Low Astigmatism

Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors