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Analysis of Peripheral Vision With Two Different IOLs

Primary Purpose

Cataract

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Peripheral vision
Sponsored by
Vienna Institute for Research in Ocular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cataract focused on measuring Cataract, Intraocular lens

Eligibility Criteria

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

Inclusion Criteria: Pseudophakic patients with an Art 40 IOL in one eye and the standard monofocal ICB00 IOL in the other eye. A larger series of patients was operated in this way at Hanusch hospital in 2021 and 2022 as the department has the strategy of implanting a new IOL that has come to market in only one eye and the standard monofocal IOL in the contralateral eye to reduce potential risks, even though the new IOL had a CE mark and was readily available on the market. Surgery should have been at least 1 month prior to study recruitment Age 21 or older Visual acuity > 0,8 Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Able to walk without walking aids Written informed consent prior to commencing study measurements. Exclusion Criteria: nystagmus or pathologies that might affect patient's fixation or physical handicaps that may decrease gait stability any ophthalmic comorbidity that may compromise the visual function or might interfere with the experiments (e.g., macular degeneration, corneal scars, pupil abnormalities, glaucoma) reduced contrast sensitivity, binocularity, and stereoscopic vision (e.g., amblyopia, strabismus) limitation of age-equivalent gait performance because of neurological, cardio-respiratory or musculoskeletal functional deficits pregnancy (pregnancy test will be performed in women of reproductive age)

Sites / Locations

  • Vienna Institute for Research in Ocular Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait analysis

Arm Description

A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision

Outcomes

Primary Outcome Measures

Peripheral vision
Peripheral vision will be assessed via gait analysis and will be compared between both eyes

Secondary Outcome Measures

Refraction
Refraction will be assessed with trial frames and will be compared between both eyes
Visual acuity
Visual acuity will be assessed with ETDRS charts and will be compared between both eyes

Full Information

First Posted
November 28, 2022
Last Updated
December 5, 2022
Sponsor
Vienna Institute for Research in Ocular Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05639075
Brief Title
Analysis of Peripheral Vision With Two Different IOLs
Official Title
Effect of an Intraocular Lens With Enhanced Peripheral Vision on Gait Performance: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Analyse the peripheral vision after cataract surgery with a new IOL compared to a standard IOL
Detailed Description
Due to continuous improvements in the technique of cataract surgery as well as the material and the design of the intraocular lenses (IOLs) over the few past decades, the removal of the opacified lens is considered to be relatively safe surgery with good refractive outcomes and a short rehabilitation time. In conjunction with these improvements of the procedure, the patients' expectations concerning their postoperative visual quality and refractive outcomes are increasing. Different IOLs have been developed to satisfy the patients' demands. Standard monofocal IOL offer good vision in either the far or the near distance, whereas spectacles are still needed for all other distances. On the other hand, multifocal IOLs allow freedom of glasses in all of the three distances (far, intermediate, near), but are, in most cases, associated with a decrease in contrast sensitivity and induction of disturbing photic phenomena (e.g., halo, starbursts, glare). Enhanced depth of focus (EDOF) IOLs are another lens option and promise good intermediate vision combined with good vision in the far distance, with spectacles only being needed for reading tasks. However, like multifocal IOLs, these lenses may be accompanied by photic phenomena, although to a lesser extent than with multifocal IOL. Recently, the so-called enhanced monofocal IOLs were introduced to the market. These IOLs are comparable to other monofocal IOLs concerning contrast sensitivity and photic phenomena, but besides offering good far visual acuity, they also slightly enhance the depth of focus with some intermediate distance vision. However, all of these lenses only provide optimal image quality in the very central visual field. Indeed it was shown that in pseudophakic patients the peripheral vision is decreased compared to phakic patients, reducing the peripheral image quality compared to that of the natural crystalline lens. According to computational and physical modelling experiments, this effect may be due to a higher degree of astigmatism and increased higher-order aberrations (HOAs) in the IOL periphery compared to those of the natural lens. This increase in astigmatism was observed in all pseudophakic individuals and did not depend on the power or the type of the implanted IOL. Peripheral vision is thought to have an impact on contrast resolution and sensitivity, detection of small stimuli and the movement of targets in the periphery, exploration and interpretation of a scene, and peripheral visual crowding. All of these tasks are important for the orientation and navigation of patients in their everyday life and misinterpretation of a scene or missing details while walking may lead to an increased risk of falls or accidents. Therefore, an IOL that improves peripheral vision could lead to a better overall functional visual quality and even patients with loss of central vision might benefit from such devices. Recently, a new non-diffractive inverted meniscus EDOF IOL, the Art40 IOL, which reduces peripheral astigmatism was introduced to the market. This IOL promises to mimic the natural crystalline lens leading to optimized field curvature, improvement in peripheral vision, and enhanced contrast sensitivity of the patients without introducing photic phenomena. Therefore, the aim of this study is to analyse if the peripheral vision after cataract surgery is increased in patients with this new IOL compared to a standard IOL.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Gait analysis
Arm Type
Experimental
Arm Description
A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision
Intervention Type
Other
Intervention Name(s)
Peripheral vision
Intervention Description
A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision
Primary Outcome Measure Information:
Title
Peripheral vision
Description
Peripheral vision will be assessed via gait analysis and will be compared between both eyes
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Refraction
Description
Refraction will be assessed with trial frames and will be compared between both eyes
Time Frame
24 months
Title
Visual acuity
Description
Visual acuity will be assessed with ETDRS charts and will be compared between both eyes
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: Pseudophakic patients with an Art 40 IOL in one eye and the standard monofocal ICB00 IOL in the other eye. A larger series of patients was operated in this way at Hanusch hospital in 2021 and 2022 as the department has the strategy of implanting a new IOL that has come to market in only one eye and the standard monofocal IOL in the contralateral eye to reduce potential risks, even though the new IOL had a CE mark and was readily available on the market. Surgery should have been at least 1 month prior to study recruitment Age 21 or older Visual acuity > 0,8 Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Able to walk without walking aids Written informed consent prior to commencing study measurements. Exclusion Criteria: nystagmus or pathologies that might affect patient's fixation or physical handicaps that may decrease gait stability any ophthalmic comorbidity that may compromise the visual function or might interfere with the experiments (e.g., macular degeneration, corneal scars, pupil abnormalities, glaucoma) reduced contrast sensitivity, binocularity, and stereoscopic vision (e.g., amblyopia, strabismus) limitation of age-equivalent gait performance because of neurological, cardio-respiratory or musculoskeletal functional deficits pregnancy (pregnancy test will be performed in women of reproductive age)
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
City
Vienna
ZIP/Postal Code
1140
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Analysis of Peripheral Vision With Two Different IOLs

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