Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT06085131 ↗Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Argos (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shammas Eye Medical Center
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.50 D. |
489 | — |
| SECONDARY The Percentage of Eyes That Achieve a Postoperative Manifest Spherical Equivalent Refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D. |
352; 518; 523 | — |
| SECONDARY Mean Absolute Prediction Error (in Diopters) |
0.21; 0.22 | — |
| SECONDARY 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 |
0.19; 0.20; 0.21; 0.16; 0.19; 0.29 | — |
Summary
Eligibility Criteria
Inclusion Criteria
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.
Exclusion Criteria
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.
- 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.
Data sourced from ClinicalTrials.gov (NCT06085131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.