Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

Completed

• Conditions: Cataract; Astigmatism

• Registration Number: NCT05278442
• Lead Sponsor: Research Insight LLC

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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-04-01
• Primary Completion: 2022-08-07
• Study Completion: 2022-08-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-28
• Last Update Posted: 2022-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoint -Postoperative magnitude of manifest astigmatism (diopters) divided by preoperative magnitude of manifest astigmatism (diopters)	Up to 3 months	Percent change in absolute magnitude of astigmatism

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint - Standard deviation of attempted vs achieved correction = standard deviation of of all individual calculated values for attempted vs achieved correction	Up to 3 months	Standard deviation of attempted vs number of achieved correction of corneal astigmatism.
Mean Attempted vs Achieved Correction (see description)	Up to 3 months	Mean attempted vs achieved correction. Attempted correction=postop target astigmatism-pre-op corneal astigmatism), achieved correction=postop manifest cylinder-pre-op corneal astigmatism, attempted vs achieved=achieved correction-attempted correction mean attempted vs achieved=average of all individual calculated values for attempted vs achieved correction

Trial Locations

Locations (1)

Quantum Vision Centers; 🇺🇸 Belleville, Illinois, United States