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CataractNCT06190925

Clinical Results of Asqelio Trifocal Toric Diffractive Intraocular Lens

An observational study of Cataract, run by AST Products, Inc. at 1 site in Spain.

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 goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Cataract
How many people
30 participants
Where
1 siteSpain
Study dates
3 Nov 2022to 12 Dec 2023
Phase
Observational
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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Regular clinical patients submitted to bilateral conventional cataract surgery using phacoemulsification and implanted with Asqelio Trifocal Toric to eliminate refractive error and presbyopia, also requiring toric correction to avoid residual astigmatism

Who may be able to join

  • Patients submitted to cataract surgery with phacoemulsification with bilateral implantation of Asqelio Trifocal Toric IOL to avoid residual astigmatism
  • Patient signing informed consent
  • Clear intraocular media, except for cataracts in both eyes prior to surgery
  • Monocular potential postoperative visual acuity of 20/25 or better

Who cannot join

  • Corneal astigmatism lower than 0.75D
  • Patients who do not provide informed consent
  • Patients who do not understand the study procedure
  • Previous corneal surgery or trauma
  • Irregular cornea (e.g. keratoconus)
  • Choroidal hemorrhage
Show all 24Show fewer
  • Microphtalmos
  • Severe corneal dystrophy
  • Uncontrolled or medically controlled glaucoma
  • Clinically significant macular changes
  • Concomitant severe eye disease
  • Non-age-related cataract
  • Severe optic nerve atrophy
  • Diabetic retinopathy
  • Proliferative diabetic retinopathy
  • Amblyopia
  • Extremely shallow anterior camera
  • Severe chronic uveítis
  • Pregnant or nursing
  • Rubella
  • Mature/dense cataract that makes it difficult to examine the fundus preoperatively.
  • Previous retinal detachment
  • Concurrent participation in other research with drugs or clinical devices
  • Expect to require another eye surgery during the study period

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • OftalVist Alicante

    Alicante, 03015

Other trials in Spain

About this study

The goal of this observational prospective clinical study is to learn about the clinical outcomes three months after binocular implantation of Asqelio Trifocal Toric IOL in 30 patients submitted to cataract surgery following standard clinical practice. The main questions it aims to answer are: How rotationally stable is the lens after implantation and how effective is in the correction of refractive astigmatism.

Additionally, the visual performance at different distances will be assessed, as well as the patient-reported outcomes.

Conditions
Cataract
Keywords
cataract surgery, intraocular lens
Medical subject headings
Cataract

What is being measured

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

  1. Refraction

    Manifest residual refraction after implantation of IOL using subjective refraction methods (D)

    Measured: 3 months after implantation

Secondary outcomes (11)

  1. Corrected Visual acuity at distance

    Visual acuity at 4m with refractive correction (LogMAR units)

    Measured: 3 months after implantation

  2. Corrected Visual acuity at intermediate distance

    Visual acuity at 60cm with refractive correction for distance (LogMAR units)

    Measured: 3 months after implantation

  3. Corrected Visual acuity at near distance

    Visual acuity at 40cm with refractive correction for distance (LogMAR units)

    Measured: 3 months after implantation

  4. Uncorrected Visual acuity at distance

    Visual acuity at 4m without correction (LogMAR units)

    Measured: 3 months after implantation

  5. Uncorrected Visual acuity at intermediate distance

    Visual acuity at 60cm without correction (LogMAR units)

    Measured: 3 months after implantation

  6. Uncorrected Visual acuity at near distance

    Visual acuity at 40cm without correction (LogMAR units)

    Measured: 3 months after implantation

  7. Binocular defocus curve

    Defocus curve obtained in binocular conditions from +2.00D to -4.00D vergence in 0.5 steps (LogMAR units)

    Measured: 3 months after implantation

  8. Rotational stability

    Change in IOL axis position determined with slit lamp (degrees)

    Measured: 3 months after implantation

  9. Contrast sensitivity function

    Contrast sensitivity determined with best correction for distance, under photopic and mesopic conditions, with and without induced glare, using the Clinical Trial Suite (CTS, M\&S Technologies, Niles, IL, EEUU) (Log CS units)

    Measured: 3 months after implantation

  10. Patient reported outcomes - Satisfaction

    Patient reported outcomes obtained by means of the CATQuest9SF questionnaire. 9 items with 4 response options, ranging from 4 for "very great difficulty/very dissatisfied" to 1 for "no difficulty/very satisfied", and a "cannot decide" additional option, which is treated as missing data.

    Measured: 3 months after implantation

  11. Patient reported outcomes - Visual Symptoms

    Patient reported outcomes on incidence and intensity of visual symptoms obtained by means of a visual symptoms questionnaire. It explores the frequency, intensity and bothersome of 10 different and common visual symptoms. Patients are asked to respond with 4 response options to the frequency of the symptoms, from 1 for "Never" to 4 "Very often", the intensity of the symptom, from 1 for "None" to 4 for "Severe", and the level of bothersome of the symptom, from 1 for "None" to 4 for "A lot".

    Measured: 3 months after implantation

Timeline

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

  1. First posted5 Jan 2024
  2. Study start3 Nov 2022
  3. Primary completion6 Nov 2023
  4. Study completion12 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06190925
Sponsor's protocol ID
ASQT042021
Status last verified
Jan 2024
First submitted
20 Dec 2023
Last updated
8 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by AST Products, Inc. at 1 site in Spain.

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 4 inclusion and 24 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 8 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 Spain. 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?

Refraction (time frame: 3 months after implantation). 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 NCT06190925.

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 8 Jan 2024.

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