AphakiaNCT05796674
Clareon IOL Retrospective Data Collection
An observational study of Aphakia and Astigmatism, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aphakia, Astigmatism
- What is being tested?
- Clareon UVA IOL, WaveTec Optiwave Refractive Analysis (ORA) System and Cataract surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 1,090 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 12 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town). Information is entered into the WaveTec AnalyzOR Database by medical professionals post cataract surgery.
Data Selection Criteria (eyes):
- Must have undergone cataract extraction by phacoemulsification with implantation of a Clareon UVA IOL (CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, or CCA0T0) using the WaveTec ORA System.
- Must have a BCDVA in the WaveTec AnalyzOR Database from ≥ 10 days after surgery.
- Predicted residual refractive error spherical equivalent (SE) ≤ 0.75 D.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database
The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.
Read the detailed description
In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.
- Conditions
- Aphakia, Astigmatism
- Being tested
- Clareon UVA IOL, WaveTec Optiwave Refractive Analysis (ORA) System, Cataract surgery
- Medical subject headings
- Aphakia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon UVA IOLDevice
Also called Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0
Clareon UVA IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery to replace the natural crystalline lens. Models CC60WF and CCA0T0 are indicated for the visual correction of aphakia. Models CCW0T3, CCW0T4, CCW0T5, and CCW0T6 are indicated for the visual correction of aphakia and preexisting corneal astigmatism.
WaveTec Optiwave Refractive Analysis (ORA) SystemDevice
Intra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation
Cataract surgeryProcedure or surgery
Cataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL
| Study group | Role | What they receive |
|---|---|---|
| Clareon UVA IOL | Eyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System Receives: Device: Clareon UVA IOL; Device: WaveTec Optiwave Refractive Analysis (ORA) System; Procedure: Cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit
The database will be reviewed for assessments of monocular (by-eye) best corrected distance visual acuity at the first postoperative visit. The first postoperative visit will be defined as the visit which occurred approximately 28 days or later from the operative visit during which time the IOL remained implanted in the eye and an eye exam was performed.
Measured: Month 1 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start18 Aug 2023
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies 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
- Retrospective
- Enrolment
- 1,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Lead, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796674
- Sponsor's protocol ID
- ILS241-R001
- Status last verified
- Oct 2023
- First submitted
- 20 Mar 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database
- ClinicalTrials.gov ID
- NCT05796674
- Acronym / sponsor ID
- ILS241-R001
- Conditions
- Aphakia, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,090 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 3 Apr 2023 (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.
The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.
Detailed description
In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon UVA IOL | – | Device: Clareon UVA IOL, Device: WaveTec Optiwave Refractive Analysis (ORA) System, Procedure: Cataract surgeryEyes that underwent cataract surgery and received a Clareon UVA IOL with the use of the WaveTec Optiwave Refractive Analysis (ORA) System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A description of the population from which the groups or cohorts will be selected (for example, primary care clinic, community sample, residents of a certain town). Information is entered into the WaveTec AnalyzOR Database by medical professionals post cataract surgery.
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 |
|---|---|---|
| Clareon UVA IOLAlso: Models CC60WF, CCW0T3, CCW0T4, CCW0T5, CCW0T6, CCA0T0Clareon UVA IOL placed in the capsular bag in the posterior chamber of the eye during cataract surgery to replace the natural crystalline lens. Models CC60WF and CCA0T0 are indicated for the visual correction of aphakia. Models CCW0T3, CCW0T4, CCW0T5, and CCW0T6 are indicated for the visual correction of aphakia and preexisting corneal astigmatism. | Device | Clareon UVA IOL |
| WaveTec Optiwave Refractive Analysis (ORA) SystemIntra-operative system used during refractive cataract surgery to capture wavefront images of the patient's eye for the purpose of optimizing IOL implantation | Device | Clareon UVA IOL |
| Cataract surgeryCataract extraction by phacoemulsification, followed by implantation with a Clareon UVA IOL | Procedure or surgery | Clareon UVA IOL |
Primary outcome
Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit
Time frame: Month 1 postoperative
The database will be reviewed for assessments of monocular (by-eye) best corrected distance visual acuity at the first postoperative visit. The first postoperative visit will be defined as the visit which occurred approximately 28 days or later from the operative visit during which time the IOL remained implanted in the eye and an eye exam was performed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- 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.
Clinical Lead, Surgical study director
Alcon Research, LLC
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 Aphakia and Astigmatism, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. 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?
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?
Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit (time frame: Month 1 postoperative). 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 18 Oct 2023.