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OpenTrials
Completed

NCT Number: NCT05278442

Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

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

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Quantum Vision Centers

Belleville, Illinois, 62226, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LaserArc

Other

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

Primary outcomes

  1. Primary Endpoint -Postoperative magnitude of manifest astigmatism (diopters) divided by preoperative magnitude of manifest astigmatism (diopters)

    Time frame: Up to 3 months

    Percent change in absolute magnitude of astigmatism

Secondary outcomes

  1. Mean Attempted vs Achieved Correction (see description)

    Time frame: 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

  2. Secondary Endpoint - Standard deviation of attempted vs achieved correction = standard deviation of of all individual calculated values for attempted vs achieved correction

    Time frame: Up to 3 months

    Standard deviation of attempted vs number of achieved correction of corneal astigmatism.

Other outcomes

  1. Exploratory Endpoint - Postoperative manifest refraction cylinder and axis is the measured magnitude of spherical and cylindrical refraction at the postoperative visit.

    Time frame: Up to 3 months

    Postoperative manifest refraction for sphere, cylinder, and axis.

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 14, 2022
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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