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

NCT ID: NCT04337892

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-20

Study Completion Date

2020-11-16

Brief Summary

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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

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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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Research Insight LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Hovanesian, MD

Role: STUDY_DIRECTOR

Research Insight LLC

Locations

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Harvard Eye Associates

Laguna Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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200118

Identifier Type: -

Identifier Source: org_study_id

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