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

NCT04337892 | Completed FDA Device

• 1 other identifier: 200118
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Average number of minutes:seconds to plan surgery for a single eye

  1 day

Secondary Outcomes (1)

• 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 Outcomes (1)

• Exploratory Endpoint: By each method the % of patients within 0.5 D of the intended postoperative manifest spherical equivalent refraction

  1 day

Interventions

Standard of Care4 DEVICE

The current standard of care for surgical planning for the participating investigator surgeon is to use Zeiss Veracity Surgical, so this same method will be used for the surgery actually performed on participating patients.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• John Hovanesian, MD

  Research Insight LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 8, 2020
• Study Start: April 20, 2020
• Primary Completion: November 16, 2020
• Study Completion: November 16, 2020
• Last Updated: July 16, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)