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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337892
• Other study ID #: 200118
• Status: Completed
• Start date: April 20, 2020
• Est. completion date: November 16, 2020

Study information

• Verified date: April 2020
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 16, 2020
• Est. primary completion date: November 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Standard of Care4
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.

Locations

Country	Name	City	State
United States	Harvard Eye Associates	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoint: By each method the % of patients within 0.5 D of the intended postoperative manifest spherical equivalent refraction		1 day
Primary	Average number of minutes:seconds to plan surgery for a single eye		1 day
Secondary	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