Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

NCT ID: NCT05278442

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2022-08-08

Brief Summary

Evaluation of the Accuracy and Safety of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction

Detailed Description

Femtosecond lasers allow the precise placement of arcuate keratotomy incisions in patients undergoing cataract surgery. Though these surgical devices have been available for several years, most current nomograms designed to reduce astigmatism with these incisions are derived from those developed for metal or diamond knives. Anecdotal reports from surgeons indicate that the previous nomograms have limited accuracy in the setting of femtosecond laser surgery.

LaserArcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions. since that time, its user base has grown because of the high accuracy its model provides. Currently over 3500 calculations are performed each month on this platform.

Conditions

Cataract; Astigmatism

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

LaserArc

LaserArcs.com is an online arcuate incision nomogram calculator initially developed on the basis of 12 months of data tabulation of patients undergoing femtosecond surgery with arcuate incisions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with cataract and otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence outcome measures.
• Patients who are 22 years of age or older
• Patients whose preoperative astigmatism was greater than 0.5 D
• Patients who were implanted with a non-toric IOL.
• Patients whose laser astigmatic keratotomy was planned using the LASER arcs nomogram

Exclusion Criteria

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.) that would, in the judgment of the investigator, influence the outcome measures of the study.
• Patients with previous refractive surgery within the past 6 months prior to cataract surgery

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Research Insight LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quantum Vision Centers

Belleville, Illinois, United States

Countries

United States

Other Identifiers

2109 LaserArc

Identifier Type: -

Identifier Source: org_study_id