Clinical trial NCT05278442: Evaluation of the Accuracy & Safety of the LaserArcs Nomogram
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Astigmatism
Lead sponsor: Research Insight LLC
Sponsor class: INDUSTRY
First posted: 2022-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study aims to enroll 50 patients that had previous cataract surgery performed with femtosecond lasers.

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.

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

Primary outcomes:
measure: Primary Endpoint -Postoperative magnitude of manifest astigmatism (diopters) divided by preoperative magnitude of manifest astigmatism (diopters)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Mean Attempted vs Achieved Correction (see description)
timeFrame: Up to 3 months
measure: Secondary Endpoint - Standard deviation of attempted vs achieved correction = standard deviation of of all individual calculated values for attempted vs achieved correction
timeFrame: Up to 3 months
Other outcomes:
measure: Exploratory Endpoint - Postoperative manifest refraction cylinder and axis is the measured magnitude of spherical and cylindrical refraction at the postoperative visit.
timeFrame: Up to 3 months
Locations:
city: Belleville
country: United States
facility: Quantum Vision Centers
state: Illinois
Study officials:
References: