search
Back to results

Performance of Two Intraocular Lenses With Extended Depth of Vision

Primary Purpose

Cataract Senile

Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
non-diffractive monofocal IOL
standard EDOF IOL
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 Senile focused on measuring Cataract, Cataract surgery, enhanced depth of focus intraocular lens

Eligibility Criteria

21 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age-related bilateral cataract
  • age 21 or older
  • visual acuity > 0.05
  • axial length: 22.0 - 26.0 mm
  • normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
  • written informed consent prior to surgery

Exclusion Criteria:

  • active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication)
  • relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS)
  • corneal decompensation or corneal endothelial cell insufficiency
  • previous ocular surgery or trauma
  • persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age)
  • corneal astigmatism > 1 dpt.
  • retinopathies

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Rayone EMV

Acrysof IQ Vivity

Arm Description

Patient will receive the non-diffractive monofocal IOL during cataract surgery

Patient will receive the standard EDOF IOL during cataract surgery

Outcomes

Primary Outcome Measures

Visual acuity at intermediate distance
The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs

Secondary Outcome Measures

Visual acuity at far distance
The visual acuity at the far distance will be measured using ETDRS charts at a distance of 4 metres and compared between the two different IOLs
Visual acuity at near distance
The visual acuity at the near distance will be measured using ETDRS charts at a distance of 40 centimetres and compared between the two different IOLs
Visual acuity in the defocus curve
The visual acuity in the defocus curve will be measured using ETDRS charts at 4 metres with the patient wearing glasses in the power range of -3.5 to +1.0 diopters (presented in 0.5 dioptre steps) and will be compared between the two IOLs
Halometry
The size of the halos depicted in degrees will be assessed using the aston halometer and will be compared between the two IOLs
Contrast sensitivity
Contast sensitvity will be measured using the Optec Vision tester and will be compared between the two IOLs
Reading speed
Reading speed will be assessed with teh Salzburg Reading Desk and will be compared between the two different IOLs

Full Information

First Posted
January 3, 2022
Last Updated
January 3, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT05194150
Brief Title
Performance of Two Intraocular Lenses With Extended Depth of Vision
Official Title
Performance of Two Non-diffractive Intraocular Lenses With Extended Depth of Vision Set for Mini-monovision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Anticipated)
Study Completion Date
January 3, 2024 (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
Comparison of the capsular bag performance of two extended depth of vision (EDOF) intraocular lenses (IOLs), the Rayone EMV and the Alcon Acrysof IQ Vivity, in a mini-monovision setting
Detailed Description
Spectacle independence is a rising aim in modern cataract surgery. Although bilateral monofocal IOL implantation, aiming for emmetropia leads to high levels of patient satisfaction for distance vision, spectacle dependence for reading and intermediate vision tasks is the usual result. The option commonly used to achieve spectacle independence in all distances are multifocal intraocular lenses. One concept of multifocality is the trifocal lens. This lens provides good vision in three focal distances: far, intermediate, and near. However, one potential disadvantage of trifocal IOLs is slightly poorer near vision with need for reading gasses for prolonged fine near work and loss of contrast sensitivity in the intermediate distance. A better intermediate performance concerning contrast vision compared to trifocal IOLs can be reached using enhanced depth of focus (EDOF) lenses. These IOLs have an extended far focus area, which reaches to the intermediate distance, providing high-quality vision over a continuous range of focus, rather than distinct foci with blur in between. In the last years several technologies for EDOF IOLs appeared on the market. The disadvantage compared to monofocal lenses in all of these technologies is the potentially worse contrast sensitivity as well as dysphotopsia. A new monofocal non-diffractive lens with an extended depth of vision (Rayone EMV) promises an increased range of functional vision and less dysphotopsias. Especially in a monovision setting, where the dominant eye is set for emmetropia and the other eye for low myopia is believe dto be a promising concept for spectacle independence. Hence, the aim of this study is to compare a new monofocal IOL wit a non-diffractive extended depth of vision (Rayone EMV) with an already established non-diffractive EDOF IOL (Alcon Acrysof IQ Vivity) in a mini-monovision setting. 96 eyes of 48 patients will be included into this study. After randomization, each patient will either receive the Rayone EMV or the Alcon Acrysof IQ Vivity in both eyes. Follow-up visits will be 2 weeks and 3 months after surgery. During these visits a slitlamp examination, measurement of the intraocular pressure, visual acuity assessment, pupil size measurement, determination of the defocus curve, contrast sensitivity measurements, reading speed detection, and a flaremeter measurement will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile
Keywords
Cataract, Cataract surgery, enhanced depth of focus intraocular lens

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rayone EMV
Arm Type
Experimental
Arm Description
Patient will receive the non-diffractive monofocal IOL during cataract surgery
Arm Title
Acrysof IQ Vivity
Arm Type
Experimental
Arm Description
Patient will receive the standard EDOF IOL during cataract surgery
Intervention Type
Device
Intervention Name(s)
non-diffractive monofocal IOL
Intervention Description
Rayone EMV
Intervention Type
Device
Intervention Name(s)
standard EDOF IOL
Intervention Description
Acrysof IQ Vivity
Primary Outcome Measure Information:
Title
Visual acuity at intermediate distance
Description
The visual acuity at the intermediate distance will be measured using ETDRS charts at a distance of 80 centimetres and compared between the two different IOLs
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Visual acuity at far distance
Description
The visual acuity at the far distance will be measured using ETDRS charts at a distance of 4 metres and compared between the two different IOLs
Time Frame
24 months
Title
Visual acuity at near distance
Description
The visual acuity at the near distance will be measured using ETDRS charts at a distance of 40 centimetres and compared between the two different IOLs
Time Frame
24 months
Title
Visual acuity in the defocus curve
Description
The visual acuity in the defocus curve will be measured using ETDRS charts at 4 metres with the patient wearing glasses in the power range of -3.5 to +1.0 diopters (presented in 0.5 dioptre steps) and will be compared between the two IOLs
Time Frame
24 months
Title
Halometry
Description
The size of the halos depicted in degrees will be assessed using the aston halometer and will be compared between the two IOLs
Time Frame
24 months
Title
Contrast sensitivity
Description
Contast sensitvity will be measured using the Optec Vision tester and will be compared between the two IOLs
Time Frame
24 months
Title
Reading speed
Description
Reading speed will be assessed with teh Salzburg Reading Desk and will be compared between the two different IOLs
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age-related bilateral cataract age 21 or older visual acuity > 0.05 axial length: 22.0 - 26.0 mm normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant written informed consent prior to surgery Exclusion Criteria: active ocular disease (e.g. chronic severe uveitis, proliferative diabetic retinopathy, chronic glaucoma not responsive to medication) relevant othe rophthalmic diseases such as pseudoexfoliation syndrome (PEX), intraoperative floppy iris syndrome (IFIS) corneal decompensation or corneal endothelial cell insufficiency previous ocular surgery or trauma persons who are pregnant or nursing (pregnancy test will be taken in women of reproductive age) corneal astigmatism > 1 dpt. retinopathies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Zeilinger, MD
Phone
01 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name or Official Title & Degree
Natascha Bayer, MSc
Phone
01 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 (VIROS), Hanusch Hospital Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
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
01 91021
Ext
57564
Email
office@viros.at
First Name & Middle Initial & Last Name & Degree
Natascha Bayer, MSc
Phone
01 91021
Ext
57564
Email
office@viros.at

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Performance of Two Intraocular Lenses With Extended Depth of Vision

We'll reach out to this number within 24 hrs