Veracity Surgical: A Time/Motion and Quality of Care Study

This study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Standard of Care4

Detailed Description

This study aims to compare the time commitment for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Harvard Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study aims to enroll 40 patients undergoing future cataract surgery.

Description

Inclusion Criteria:

• Patients at least 18 years of age with upcoming cataract surgery. At least 25% of enrolled eyes must be post-refractive, and 25% must require astigmatic planning (arcuate incision or toric IOL)
• Patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence refractive outcome or interfere with postoperative refraction accuracy.

Exclusion Criteria:

• Patients with visually significant comorbidities (corneal, retina, optic nerve disease, not including prior refractive surgery) that could significantly affect their ability to have accurate preoperative biometry or postoperative refraction.
• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would interfere with postoperative refraction.
• Patients with > grade 2 or greater posterior capsule opacity

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average number of minutes:seconds to plan surgery for a single eye	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
By each method the number of total data points where a human is required manually to transcribe data from one place to another.	1 day

Other Outcome Measures

Outcome Measure	Time Frame
Exploratory Endpoint: By each method the % of patients within 0.5 D of the intended postoperative manifest spherical equivalent refraction	1 day

Collaborators and Investigators

• Sponsor: Research Insight LLC
• Investigators: Study Director: John Hovanesian, MD, Research Insight LLC

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): November 16, 2020
• Study Completion (Actual): November 16, 2020

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 6, 2020
• First Posted (Actual): April 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 200118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes