Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05278442
• Other study ID #: 2109 LaserArc
• Status: Completed
• Start date: April 1, 2022
• Est. completion date: August 8, 2022

Study information

• Verified date: October 2022
• Source: Research Insight LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 8, 2022
• Est. primary completion date: August 7, 2022
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Quantum Vision Centers	Belleville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Research Insight LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory Endpoint - Postoperative manifest refraction cylinder and axis is the measured magnitude of spherical and cylindrical refraction at the postoperative visit.	Postoperative manifest refraction for sphere, cylinder, and axis.	Up to 3 months
Primary	Primary Endpoint -Postoperative magnitude of manifest astigmatism (diopters) divided by preoperative magnitude of manifest astigmatism (diopters)	Percent change in absolute magnitude of astigmatism	Up to 3 months
Secondary	Mean Attempted vs Achieved Correction (see description)	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	Up to 3 months
Secondary	Secondary Endpoint - Standard deviation of attempted vs achieved correction = standard deviation of of all individual calculated values for attempted vs achieved correction	Standard deviation of attempted vs number of achieved correction of corneal astigmatism.	Up to 3 months