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Clinical Trials/NCT04337892
NCT04337892
Completed
Not Applicable

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

Research Insight LLC1 site in 1 country40 target enrollmentApril 20, 2020
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ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Research Insight LLC
Enrollment
40
Locations
1
Primary Endpoint
Average number of minutes:seconds to plan surgery for a single eye
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2020
End Date
November 16, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 day

Secondary Outcomes

  • 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)

Study Sites (1)

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