CataractNCT04936256
Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 28 Jul 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option
- Gender: Males and Females.
- Age: 50 or older
- Willing and able to provide written informed consent for participation in the study
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- Willing and able to comply with scheduled visits and other study procedures.
- Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- Potential postoperative visual acuity of (20/25 Snellen) or better in both eyes
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
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- Macular pathology (e.g. ARMD, ERM)
- History of retinal detachment
- Any patient based on Barrett toric calculator that will have ≥ 0.75D residual astigmatism if Clareon® non-toric IOL is implanted
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity
- Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating)
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).
Read the detailed description
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.
- Conditions
- Cataract
- Being tested
- Clareon
- Keywords
- Monofocal IOL, Clareon
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClareonDevice
Clareon monofocal intraocular lens (IOL)
| Study group | Role | What they receive |
|---|---|---|
| Bilateral implantation of the Clareon monofocal IOL | Clareon monofocal intraocular lens (IOL) Receives: Device: Clareon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractive Stability
Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)
Measured: 3 months
Secondary outcomes (5)
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity in logMAR
Measured: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate visual acuity in logMAR
Measured: 3 months
Binocular Corrected Distance Visual Acuity
Binocular corrected distance visual acuity in logMAR
Measured: 3 months
Binocular Distance-corrected Intermediate Visual Acuity
Binocular distance-corrected intermediate visual acuity in logMAR
Measured: 3 months
Binocular Defocus Curve
A binocular defocus curve is obtained by measuring visual acuity (logMAR) at different spherical powers (D).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start2 Jul 2021
- Primary completion28 Jul 2022
- Study completion28 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Clayton Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936256
- Sponsor's protocol ID
- CB-20-001
- Status last verified
- Aug 2024
- First submitted
- 15 Jun 2021
- Last updated
- 7 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Binocular Visual Acuity and Refractive Stability in the Alcon Clareon Intraocular Lens
- ClinicalTrials.gov ID
- NCT04936256
- Acronym / sponsor ID
- CB-20-001
- Conditions
- Cataract
- Keywords
- Monofocal IOL, Clareon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 28 Jul 2022 (actual)
- Study completion
- 28 Jul 2022 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months).
Detailed description
This study is a single-arm, evaluator masked clinical evaluation study of refractive stability, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and defocus curve.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral implantation of the Clareon monofocal IOL | – | Device: ClareonClareon monofocal intraocular lens (IOL) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects ≥50 years of age presenting for cataract surgery who are appropriate candidates for intraocular lens implantation.
Key inclusion criteria (9 listed)
- Note: Ocular criteria must be met in both eyes.
- Presenting for uncomplicated bilateral cataract surgery and have an interest in an IOL option
- Gender: Males and Females.
- Age: 50 or older
- Willing and able to provide written informed consent for participation in the study
Key exclusion criteria (13 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
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 |
|---|---|---|
| ClareonClareon monofocal intraocular lens (IOL) | Device | Bilateral implantation of the Clareon monofocal IOL |
Primary outcome
Refractive Stability
Time frame: 3 months
Refractive stability (spherical equivalent change ≤ 0.50D from 1-month to 3-months)
5 secondary outcomes
Binocular Uncorrected Distance Visual Acuity
Time frame: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Corrected Distance Visual Acuity
Time frame: 3 months
Binocular Distance-corrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Defocus Curve
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clayton Blehm, MD principal investigator
Gainesville Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
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 9 inclusion and 13 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 7 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Refractive Stability (time frame: 3 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 7 Aug 2024.