Clinical trial NCT06085131: Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
Official title: Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Lead sponsor: Shammas Eye Medical Center
Sponsor class: OTHER
Collaborators: name: Sengi
First posted: 2023-10-16
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.

Brief 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. Clinical evaluations will include measurement of visual acuity, manifest refraction, and preoperative biometry.


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.

Primary outcomes:
measure: The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.
timeFrame: 2 months postoperative
Secondary outcomes:
measure: The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.250D, ≤ ±0.75D and ≤ ±1.00D.
timeFrame: 2 months postoperative
measure: The Mean Predictive Error and its standard deviation after constant personalization for the entire series.
timeFrame: 2 months postoperative
measure: The Mean Predictive Errors in the short eyes and in the long eyes
timeFrame: 2 months postoperative
Other outcomes:
Locations:
city: Encino
country: United States
facility: Colvard-Kandavel Eye Center
state: California
city: Lynwood
country: United States
facility: Shammas Eye Medical Center
state: California
city: Whittier
country: United States
facility: Shammas Eye Center
state: California
city: Frankfort
country: United States
facility: Multack Eye Care, Sc
state: Illinois
city: Olympia Fields
country: United States
facility: Multack Eye Care, SC
state: Illinois
city: Albuquerque
country: United States
facility: Juliette Eye Institute
state: New Mexico
Study officials:
affiliation: Shammes Eye Medical Center
name: H J Shammas, MD
role: PRINCIPAL_INVESTIGATOR
References: