NCT06085131

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

October 31, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

1.2 years

First QC Date

October 10, 2023

Last Update Submit

January 29, 2025

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • The percentage of eyes that achieve a postoperative manifest spherical equivalent refraction ≤ ±0.50 D.

    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.

    2 months postoperative

  • The Mean Predictive Error and its standard deviation after constant personalization for the entire series.

    2 months postoperative

  • The Mean Predictive Errors in the short eyes and in the long eyes

    2 months postoperative

Study Arms (1)

Argos Biometer

Preoperative biometry with the Argos device

Device: Argos

Interventions

ArgosDEVICE

Argos Biometer

Argos Biometer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible test subjects will be adults who are interested in and appropriate candidates for cataract surgery.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Colvard-Kandavel Eye Center

Encino, California, 91316, United States

Location

Shammas Eye Medical Center

Lynwood, California, 90262, United States

Location

Shammas Eye Center

Whittier, California, 90602, United States

Location

Multack Eye Care, Sc

Frankfort, Illinois, 60461, United States

Location

Multack Eye Care, SC

Olympia Fields, Illinois, 60461, United States

Location

Juliette Eye Institute

Albuquerque, New Mexico, 87113, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • H J Shammas, MD

    Shammes Eye Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2023

First Posted

October 16, 2023

Study Start

October 31, 2023

Primary Completion

January 29, 2025

Study Completion

January 29, 2025

Last Updated

January 30, 2025

Record last verified: 2025-01

Locations

US(6)