Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study

Cataract Clinical Trial

Official title:

Accuracy of the New Barrett TAL Formula With the Argos Measurements: A Multicenter Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085131
• Other study ID #: HJS-23-01
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: November 2023
• Source: Shammas Eye Medical Center
• Contact: H J Shammas, MD
• Phone: 3106389391
• Email: hshammas[@]aol.com
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 590
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Argos
Argos Biometer

Locations

Country	Name	City	State
United States	Juliette Eye Institute	Albuquerque	New Mexico
United States	Colvard-Kandavel Eye Center	Encino	California
United States	Multack Eye Care, Sc	Frankfort	Illinois
United States	Shammas Eye Medical Center	Lynwood	California
United States	Multack Eye Care, SC	Olympia Fields	Illinois
United States	Shammas Eye Center	Whittier	California

Sponsors (2)

Lead Sponsor	Collaborator
Shammas Eye Medical Center	Sengi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction = ±0.50 D.		2 months postoperative
Secondary	The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction = ±0.250D, = ±0.75D and = ±1.00D.		2 months postoperative
Secondary	The Mean Predictive Error and its standard deviation after constant personalization for the entire series.		2 months postoperative
Secondary	The Mean Predictive Errors in the short eyes and in the long eyes	The Mean Predictive Errors in the short eyes and in the long eyes (Short AL<22.5mm, Long AL >24.5mm and Medium AL 22.6mm to 24.4mm), and the percentage of eyes that achieve a postoperative manifest spherical equivalent refraction = ±0.25 D, = ±0.50 D, = ±0.75 D and = ±1.00 D in each of these categories.	2 months postoperative