Conventional Surgery vs. Verion/VerifEye
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|ClinicalTrials.gov Identifier: NCT02513745|
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : August 22, 2019
Last Update Posted : September 4, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cataract Astigmatism||Device: Conventional Device: Refractive Cataract Suite (Verion + ORA)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Refractive Outcomes Evaluation of the Verion Image Guided System + ORA System With VerifEye|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||May 5, 2017|
|Actual Study Completion Date :||May 5, 2017|
Active Comparator: Conventional
Surgeon's standard of care prior to getting VERION. Spherical power will be selected using the surgeon's preferred formula (Haigis, Holladay 2, Holladay, or other) and biometry method (IOL Master, Lenstar). Astigmatism correction will be planned using the surgeon's preferred keratometry method and calculator/nomogram to determine toric power and corneal incisions (i.e. Alcon toric calculator, Holladay toric calculator, Abbott Medical Optics (AMO) LRI calculator, etc). At time of surgery, axis of placement will be marked using blue ink marks. Corneal incisions will be made manually.
Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
Active Comparator: Refractive Cataract Suite (Verion + ORA)
Digital Surgical Planning and Positioning Tools + ORA System with VerifEye or VerifEye +. Spherical power of the IOL will be selected using the Verion Planner with the surgeon's preferred formula with an optimized A-constant (Haigis, Holladay 2, Holladay, or other). Both toric lenses and corneal incisions will be calculated with the Verion Planner using the Verion Reference Unit keratometry and white to white measurements, and Lenstar biometry. The VERION Digital Markers L and M will be used for axis of placement and confirmed using ORA System with VerifEye or VerifEye +.
Device: Refractive Cataract Suite (Verion + ORA)
Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
- Residual Refractive Cylinder [ Time Frame: Three months ]This is the manifest refractive cylinder measured 3 months after surgery. Note that because cataract surgery has been performed, there is no associated baseline value.
- Residual Mean Spherical Equivalent Refraction [ Time Frame: Three months ]This is the mean of the spherical equivalent refraction (sphere + 0.5*cylinder) from each eye. Note that because cataract surgery has been performed, there is no associated baseline value.
- Residual Corneal Astigmatism [ Time Frame: Three months ]This is the anterior corneal astigmatism measured through keratometry. Note that because cataract surgery has been performed, there is no associated baseline value.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02513745
|United States, South Carolina|
|Carolina Eyecare Physicians, LLC|
|Mount Pleasant, South Carolina, United States, 29464|
|Principal Investigator:||Kerry D Solomon, MD||Carolina Eyecare Physicians, LLC|