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Completed

NCT Number: NCT04337892

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

    Time frame: 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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2020
Registry last updated
Jul 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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