Evaluation of the Accuracy & Safety of the LaserArcs Nomogram
Retrospective Evaluation of the Accuracy and Safety of the LaserArcs Femtosecond Cataract Surgery Arcuate Incision Nomogram in Patients Undergoing Cataract Surgery and Astigmatism Reduction
1 other identifier
observational
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 8, 2022
CompletedNovember 1, 2022
October 1, 2022
4 months
February 3, 2022
October 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mean Attempted vs Achieved Correction (see description)
Up to 3 months
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
Other Outcomes (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
Interventions
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
Eligibility Criteria
The study aims to enroll 50 patients that had previous cataract surgery performed with femtosecond lasers.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quantum Vision Centers
Belleville, Illinois, 62226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
March 14, 2022
Study Start
April 1, 2022
Primary Completion
August 7, 2022
Study Completion
August 8, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10