search
Back to results

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

Primary Purpose

Cataract, Astigmatism

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
toric intraocular lens
non toric intraocular lens
Sponsored by
Prim. Prof. Dr. Oliver Findl, MBA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Low Astigmatism

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Toric intraocular lens (IOL)

Non toric intraocular lens (IOL)

Arm Description

toric intraocular lens for low astigmatism correction

non toric intraocular lens

Outcomes

Primary Outcome Measures

Subjective refraction to detect remaining astigmatism (in Diopters) between both groups

Secondary Outcome Measures

Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens
Wavefront analysis of high order aberrations (root mean square, in microns)
Questionnaire to asses patients subjective satisfaction with visual outcome
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

Full Information

First Posted
April 30, 2018
Last Updated
October 1, 2019
Sponsor
Prim. Prof. Dr. Oliver Findl, MBA
search

1. Study Identification

Unique Protocol Identification Number
NCT03538964
Brief Title
Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
Acronym
Low Asti
Official Title
Assessing the Astigmatism Reducing Effect With Toric IOLs in Eyeswith Low Astigmatism
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
May 2, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prim. Prof. Dr. Oliver Findl, MBA

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Astigmatism
Keywords
Cataract, Low Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Toric intraocular lens (IOL)
Arm Type
Active Comparator
Arm Description
toric intraocular lens for low astigmatism correction
Arm Title
Non toric intraocular lens (IOL)
Arm Type
Sham Comparator
Arm Description
non toric intraocular lens
Intervention Type
Procedure
Intervention Name(s)
toric intraocular lens
Intervention Description
cataract surgery with implantation of an toric intraocular lens
Intervention Type
Procedure
Intervention Name(s)
non toric intraocular lens
Intervention Description
cataract surgery with implantation of a non toric intraocular lens
Primary Outcome Measure Information:
Title
Subjective refraction to detect remaining astigmatism (in Diopters) between both groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Biometrical measurement of axial length (in mm), anterior chamber depth (in mm), corneal astigmatism (radii and axial degrees)
Time Frame
12 months
Title
Purkinjemeter measurement of Tilt (in degrees) and Decentration (in degrees) of the intraocular lens
Time Frame
12 months
Title
Wavefront analysis of high order aberrations (root mean square, in microns)
Time Frame
12 months
Title
Questionnaire to asses patients subjective satisfaction with visual outcome
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julius Hienert, MD
Phone
+43 01 91021 57564
Email
j.hienert@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Hirnschall, MD
Phone
+43 01 91021 57564
Email
nino.hirnschall@googlemail.com
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS)
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julius Hienert, MD
Phone
01 90121-57564
Email
j.hienert@viros.at
First Name & Middle Initial & Last Name & Degree
Nino Hirnschall, MD
Phone
01 90121-57564
Email
nino.hirnschall@wgkk.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs