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

Completed

• Conditions: Cataract

• Registration Number: NCT04337892
• Lead Sponsor: Research Insight LLC

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.

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 Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-08
• Study Start: 2020-04-20
• Primary Completion: 2020-11-16
• Study Completion: 2020-11-16
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average number of minutes:seconds to plan surgery for a single eye	1 day

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States