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Rotational Stability of the TECNIS Eyhance Toric

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Cataract surgery
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract, Astigmatism, Toric intraocular lens

Eligibility Criteria

21 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cataract
  • Age 21 and older
  • Regular corneal astigmatism > 0.75 dioptres
  • Written informed consent prior to surgery

Exclusion Criteria:

  • Relevant other ophthalmic diseases such as pseudoexfoliation, traumatic cataract, corneal scars or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome)
  • High myopia (> 29 mm AL)
  • Irregular corneal astigmatism on corneal topography
  • Pregnancy (a 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 Type

Experimental

Arm Label

Eyhance toric II

Arm Description

The Eyhance toric II intraocular lens will be implanted in one of the patients eyes during cataract surgery

Outcomes

Primary Outcome Measures

Rotational stability
The change in the intraocular lens axis (given in degrees) of the Eyhance toric IOL of one eye will be analysed by taking photographs of the IOL and will be compared between the different study time points.

Secondary Outcome Measures

Distance visual acuity
Distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the different study time points.

Full Information

First Posted
November 2, 2021
Last Updated
November 15, 2021
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05126368
Brief Title
Rotational Stability of the TECNIS Eyhance Toric
Official Title
Rotational Stability of the TECNIS Eyhance Toric II IOL
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Anticipated)
Study Completion Date
November 29, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vienna Institute for Research in Ocular Surgery

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
Evaluation of the rotational stability of a new toric intraocular lens (IOL), the TECNIS Eyhance toric II.
Detailed Description
With increasing demands of patients concerning the refractive outcome after cataract surgery, toric intraocular lenses (IOLs) have become more popular. Originally, toric IOLs were used mainly to correct corneal astigmatism in patients with high degrees of astigmatism. Since a couple of years, toric IOLs are available from numerous manufacturers to correct moderate or even low amounts of astigmatism which are much more prevalent. Only about 8% of the population has a corneal astigmatism of 2.0 D or more, while the incidence of a corneal astigmatism of 0.75 D or more is about 30%. The use of toric IOLs in this population results in less spectacle dependence due to the astigmatic correction. Toric IOLs became the gold standard to correct corneal astigmatism during cataract surgery and rotational stability and axis alignment are critical to the efficacy of the surgical outcome. Misalignment may be caused intra- or postoperatively. Intraoperatively, misalignment may happen due to cyclotorsion of the eye in supine position or due to peribulbar anaesthesia and imprecision of positioning the IOL along the correct meridian in the capsular bag. This can be compensated for by preoperative corneal marking in the sitting position and meticulous positioning of the IOL during surgery. However, there are several other risk factors that influence rotational stability in the postoperative period, such as IOL design, haptic design and material, axial length, capsulorhexis size, capsular bag diameter and capsular bag shrinkage. Long-term success of toric IOLs depends on rotational stability, nevertheless rotation mostly happens in the early postoperative period and once the anterior and posterior capsules fuse, IOL rotation is less frequent. A study by Kim et al. showed no significant differences in lens rotation between the early and late postoperative follow-up, and Kwartz et al. showed no significant differences between the two periods when different lens materials were used. Varsits et al. reported that rotation of toric IOLs is typically seen within the first hour after implantation. It is known that tilt and decentration of the IOL can lead to a negative effect on optical performance and horizontal tilt induces against-the-rule-astigmatism. Every degree of rotation results in a loss of 3.3% of cylindrical power and misalignment of more than 10 degrees is considered an indication of surgical repositioning. The aim of this study is therefore to evaluate the rotational stability of the TECNIS Eyhance toric II intraocular lens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Eyhance toric II
Arm Type
Experimental
Arm Description
The Eyhance toric II intraocular lens will be implanted in one of the patients eyes during cataract surgery
Intervention Type
Other
Intervention Name(s)
Cataract surgery
Intervention Description
During cataract surgery the Eyhance toric II intraocular lens will be implanted in one eye of the patient
Primary Outcome Measure Information:
Title
Rotational stability
Description
The change in the intraocular lens axis (given in degrees) of the Eyhance toric IOL of one eye will be analysed by taking photographs of the IOL and will be compared between the different study time points.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Distance visual acuity
Description
Distance visual acuity will be determined using ETDRS-charts in a distance of 4 metres and differences in refraction will be compared between the different study time points.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cataract Age 21 and older Regular corneal astigmatism > 0.75 dioptres Written informed consent prior to surgery Exclusion Criteria: Relevant other ophthalmic diseases such as pseudoexfoliation, traumatic cataract, corneal scars or other co-morbidities that could affect capsular bag stability (e.g. Marfan syndrome) High myopia (> 29 mm AL) Irregular corneal astigmatism on corneal topography Pregnancy (a pregnancy test will be taken preoperatively in women of reproductive age)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Zeilinger, MD
Phone
+43 1 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Ruiss, MSc
Phone
+43 1 91021
Ext
57564
Email
office@viros.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Findl, MD
Organizational Affiliation
Vienna Institute for Research in Ocular Surgery
Official's Role
Principal Investigator
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
Johannes Zeilinger, MD
Phone
+43 1 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Manuel Ruiss, MSc
Phone
+43 1 91021
Ext
57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Rotational Stability of the TECNIS Eyhance Toric

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