CataractNCT05639075
Analysis of Peripheral Vision With Two Different IOLs
A study testing Peripheral vision in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
Analyse the peripheral vision after cataract surgery with a new IOL compared to a standard IOL Read more about this study
- Who is it for?
- Ages 21 to 105 years
- Conditions the study is for
- Cataract
- What is being tested?
- Peripheral vision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustria
- Study dates
- 1 Nov 2022to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Intraocular Lens With Enhanced Peripheral Vision on Gait Performance: a Pilot Study
Analyse the peripheral vision after cataract surgery with a new IOL compared to a standard IOL
Read the 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.
- Conditions
- Cataract
- Being tested
- Peripheral vision
- Keywords
- Cataract, Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral visionOther
A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis | Experimental | A gait analysis test will be performed in each patient after cataract surgery to test peripheral vision Receives: Other: Peripheral vision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral vision
Peripheral vision will be assessed via gait analysis and will be compared between both eyes
Measured: 24 months
Secondary outcomes (2)
Refraction
Refraction will be assessed with trial frames and will be compared between both eyes
Measured: 24 months
Visual acuity
Visual acuity will be assessed with ETDRS charts and will be compared between both eyes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, Principal investigator, Vienna Institute for Research in Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639075
- Sponsor's protocol ID
- Voptica
- Status last verified
- Nov 2022
- First submitted
- 28 Nov 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Intraocular Lens With Enhanced Peripheral Vision on Gait Performance: a Pilot Study
- ClinicalTrials.gov ID
- NCT05639075
- Acronym / sponsor ID
- Voptica
- Conditions
- Cataract
- Keywords
- Cataract, Intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis | Experimental | Other: Peripheral visionA gait analysis test will be performed in each patient after cataract surgery to test peripheral vision |
Who may qualify
- Ages
- 21 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral visionA gait analysis test will be performed in each patient after cataract surgery to test peripheral vision | Other | Gait analysis |
Primary outcome
Peripheral vision
Time frame: 24 months
Peripheral vision will be assessed via gait analysis and will be compared between both eyes
2 secondary outcomes
Refraction
Time frame: 24 months
Visual acuity
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Findl, MD principal investigator
Vienna Institute for Research in Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral vision in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral vision (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.