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Cataract SenileNCT06196593

Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens

A study testing AcrySof™ IQ Vivity™ Toric intraocular lens in people with Cataract Senile and Intraocular Lens Complication, run by LEC Eye Centre at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AcrySof™ IQ Vivity™ Toric intraocular lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteMalaysia
Study dates
1 Apr 2022to 30 Apr 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • patients aged 18 years or older
  • bilateral significant cataracts
  • bilateral significant corneal astigmatism

Who cannot join

  • previous refractive surgery
  • amblyopia
  • strabismus
  • any ocular co-morbidity which could impact on final visual acuity
  • pre-existing zonular weakness
  • capsular instability or compromise

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • LEC Eye Centre

    Ipoh, Perak, 30450

Other trials in Malaysia

About this study

Official title: Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens

The objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.

Read the detailed description

This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.

Being tested
AcrySof™ IQ Vivity™ Toric intraocular lens
Keywords
cataract surgery, intraocular lens, non-diffractive extended depth of focus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcrySof™ IQ Vivity™ Toric intraocular lensDevice

    Uneventful phacoemulsification and implantation of IOL

Study groups in NCT06196593
Study groupRoleWhat they receive
All eyesExperimentalAll eyes implanted with AcrySof™ IQ Vivity™ Toric intraocular lens
Receives: Device: AcrySof™ IQ Vivity™ Toric intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Binocular UDVA

    Binocular Uncorrected Distance Visual Acuity

    Measured: 3 months

  2. Binocular UIVA

    Binocular Uncorrected Intermediate Visual Acuity

    Measured: 3 months

  3. Binocular UNVA

    Binocular Uncorrected Near Visual Acuity

    Measured: 3 months

Secondary outcomes (9)

  1. CDVA

    Corrected Distance Visual Acuity

    Measured: 3 months

  2. DCIVA

    Distance Corrected Intermediate Visual Acuity

    Measured: 3 months

  3. DCNVA

    Distance Corrected Near Visual Acuity

    Measured: 3 months

  4. MRSE

    Mean Refractive Spherical Equivalent

    Measured: 3 months

  5. Rotational Stability

    Degree of rotation of intraocular lens

    Measured: 1 month

  6. Binocular Defocus Curve

    Measurement of the performance of the Intraocular lens at different distances

    Measured: 3 months

  7. Contrast Sensitivity

    Measurement of the contrast sensitivity after implantation with this intraocular lens

    Measured: 3 months

  8. QUVID

    Questionnaire on Visual Disturbances

    Measured: 3 months

  9. VF-14

    Visual function 14 index of questions designed to assess difficulty performing daily visual tasks

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2024
  2. Study start1 Apr 2022
  3. Primary completion30 Apr 2023
  4. Study completion30 Apr 2023

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06196593
Sponsor's protocol ID
VTLEC
Status last verified
Dec 2023
First submitted
24 Dec 2023
Last updated
9 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AcrySof™ IQ Vivity™ Toric intraocular lens in people with Cataract Senile and Intraocular Lens Complication, run by LEC Eye Centre at 1 site in Malaysia.

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 3 inclusion and 6 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: finished, as of the sponsor's last update on 9 Jan 2024. 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 Malaysia. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Binocular UDVA (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06196593.

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 9 Jan 2024.

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