N/A
N=84
Conventional Surgery vs. Verion/VerifEye
Cataract · Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT02513745 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Residual Refractive Cylinder — 0.28; 0.33 Diopters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Conventional (Device); Refractive Cataract Suite (Verion + ORA) (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Carolina Eyecare Physicians, LLC
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Residual Refractive Cylinder |
0.28; 0.33 | — |
| SECONDARY Residual Mean Spherical Equivalent Refraction |
0.06; 0.02 | — |
| SECONDARY Residual Corneal Astigmatism |
1.12; 1.16 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation and astigmatism correction.
- Willing and able to provide written informed consent for participation in the study
- Willing and able to comply with scheduled visits and other study procedures.
Exclusion Criteria
- Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.
- Uncontrolled diabetes.
- Use of any systemic or topical drug known to interfere with visual performance.
- Contact lens use during the active treatment portion of the trial.
- Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
- Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules
- Previous refractive surgery.
- Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
Data sourced from ClinicalTrials.gov (NCT02513745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.