Evaluation of the Accuracy & Safety of the LaserArcs Nomogram

Sponsor
Research Insight LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05278442
Collaborator
(none)
50
1
6.2
8.1

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: LaserArc

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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
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
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Aug 7, 2022
Anticipated Study Completion Date :
Oct 7, 2022

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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.

Other Outcome Measures

  1. Exploratory Endpoint - Postoperative manifest refraction cylinder and axis is the measured magnitude of spherical and cylindrical refraction at the postoperative visit. [Up to 3 months]

    Postoperative manifest refraction for sphere, cylinder, and axis.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quantum Vision Centers Belleville Illinois United States 62226

Sponsors and Collaborators

  • Research Insight LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Research Insight LLC
ClinicalTrials.gov Identifier:
NCT05278442
Other Study ID Numbers:
  • 2109 LaserArc
First Posted:
Mar 14, 2022
Last Update Posted:
Apr 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2022