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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Austria1 site
  • Vienna Institute for Research in Ocular Surgery

    Vienna, 1140

Other trials in Austria

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 groups in NCT05639075
Study groupRoleWhat they receive
Gait analysisExperimentalA 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.

  1. Peripheral vision

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

    Measured: 24 months

Secondary outcomes (2)
  1. Refraction

    Refraction will be assessed with trial frames and will be compared between both eyes

    Measured: 24 months

  2. 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.

  1. First posted6 Dec 2022
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2023 (estimated)
  4. Study completion1 Nov 2024 (estimated)

Resources

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)
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

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.

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