CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Conventional +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02513745
NCT02513745N/ACompleted

Refractive Outcomes Evaluation of the Verion Image Guided System + ORA System With VerifEye

Carolina Eyecare Physicians, LLC·interventional·Posted Aug 3, 2015·Updated Sep 4, 2019

In Brief

A clinical study evaluating Conventional and Refractive Cataract Suite (Verion + ORA) for Cataract and Astigmatism. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Nowadays cataract patient's expectations are closer to those of refractive surgery patients. Patients want to be spectacle independent. However, fifteen to twenty percent of cataract surgery patients have from 1.00 to 3.00 diopters (D) of corneal astigmatism which makes achieving spectacle independence unlikely in this patients unless the astigmatism is treated at the time of cataract surgery. Option to treat this astigmatism include corneal or limbal incisions (LRIs), the use of toric intraocular lenses (IOLs) or LASIK. Regardless of the treatment of choice to correct the astigmatism at time of cataract extraction, a treatment plan has to be calculated preoperatively. This planning include: keratometry measurements and the use of a calculator to estimate the treatment and orientation of IOL and/or placement of the LRIs. New technology has been developed and is widely used. Among this technology, we have the VERION Image Guided System. This system encompasses a reference unit that takes a picture of the eye with the patient in the sitting position creating image of the patient's eye, capturing scleral vessels, limbus and iris features. It measures keratometry as well as the corneal diameter (limbus) and pupil size. The information captured is transferred automatically to its planner where IOL power calculation and astigmatism correction calculation are completed. Additionally, intraoperative wavefront aberrometry has been used in the last couple of years with increase success.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsScience in Vision

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 3, 2015
Enrollment StartJun 1, 2015
Primary CompletionMay 5, 2017
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.9 years ago

Interventions

Conventionaldevice

Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.

Refractive Cataract Suite (Verion + ORA)device

Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.