CataractNCT06085131
Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
An observational study of Cataract, run by Shammas Eye Medical Center at 6 sites in United States.
Trial summary
This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Argos
- Type of treatment
- Medical device
- How many people
- 523 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Oct 2023to 29 Jan 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Cataract surgery that was completed without complications with biometry measured using the Argos biometer.
- Subjects that elect Clareon SY60WF aspheric lens (Alcon, Fort Worth, TX).
- Potential post-operative visual acuity of better than logMAR 0.30 (20/40).
- BTAL was used to determine the IOL power implanted.
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.
- Patients with pre-existing ocular pathology that in the opinion of the principial investigator would influence the postoperative refraction.
- Any disease or pathology, including but not limited to irregular corneal astigmatism and keratoconus, that is expected to reduce the potential postoperative BCDVA to a level worse than 20/40.
- Patients with history of previous ocular surgery.
- Patients with signs of inability to understand consent for study and procedure planned.
- Eyes with intraoperative or postoperative complications.
Show all 10Show fewer
- Suboptimal surgical outcomes that are not related to the treatment plan, e.g. capsular tear, cystoid macular edema.
- Astigmatism >±0.75D.
- Each 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Juliette Eye Institute
Albuquerque, New Mexico, 87113
Colvard-Kandavel Eye Center
Encino, California, 91316
Multack Eye Care, Sc
Frankfort, Illinois, 60461
Shammas Eye Medical Center
Lynwood, California, 90262
Multack Eye Care, SC
Olympia Fields, Illinois, 60461
Shammas Eye Center
Whittier, California, 90602
About this study
This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
- Conditions
- Cataract
- Being tested
- Argos
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArgosDevice
Argos Biometer
| Study group | Role | What they receive |
|---|---|---|
| Argos Biometer | Preoperative biometry with the Argos device Receives: Device: Argos |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D.
Measured: 2 months postoperative
Secondary outcomes (3)
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.
Measured: 2 months postoperative
Mean Absolute Prediction Error (in Diopters)
Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.
Measured: 2 months postoperative
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm
The Mean Predictive Errors in Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm eyes. Prediction error is the difference in diopters (D) between the prediction made by the BTAL or BUII preoperative planning formulas, and the measured postoperative refraction. A value closer to 0 is better.
Measured: 2 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start31 Oct 2023
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
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
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shammas Eye Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- H J Shammas, MD, Principal investigator, Shammes Eye Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085131
- Sponsor's protocol ID
- HJS-23-01
- Status last verified
- Apr 2026
- First submitted
- 10 Oct 2023
- Last updated
- 27 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT06085131
- Acronym / sponsor ID
- HJS-23-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Shammas Eye Medical CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 16 Oct 2023 (actual)
- Results
- Posted 27 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multi-site, multi-surgeon, observational study of refractive accuracy with the Argos using BTAL after successful cataract surgery. Subjects will be assessed pre-operatively, operatively and at 5-8 weeks postoperatively. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Argos Biometer | – | Device: ArgosPreoperative biometry with the Argos device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.
Key inclusion criteria (5 listed)
- Cataract surgery that was completed without complications with biometry measured using the Argos biometer.
- Subjects that elect Clareon SY60WF aspheric lens (Alcon, Fort Worth, TX).
- Potential post-operative visual acuity of better than logMAR 0.30 (20/40).
- BTAL was used to determine the IOL power implanted.
Key exclusion criteria (10 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.
- Patients with pre-existing ocular pathology that in the opinion of the principial investigator would influence the postoperative refraction.
- Any disease or pathology, including but not limited to irregular corneal astigmatism and keratoconus, that is expected to reduce the potential postoperative BCDVA to a level worse than 20/40.
- Patients with history of previous ocular surgery.
- Patients with signs of inability to understand consent for study and procedure planned.
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 |
|---|---|---|
| ArgosArgos Biometer | Device | Argos Biometer |
Primary outcome
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D.
Time frame: 2 months postoperative
3 secondary outcomes
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.
Time frame: 2 months postoperative
Mean Absolute Prediction Error (in Diopters)
Time frame: 2 months postoperative
Mean Absolute Prediction Error (in Diopters) in Eyes With Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm
Time frame: 2 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
H J Shammas, MD principal investigator
Shammes Eye Medical Center
6 sites 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 Shammas Eye Medical Center at 6 sites 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 5 inclusion and 10 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 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 27 May 2026). 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?
The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D. (time frame: 2 months 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 27 May 2026.