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Trial record 1 of 1 for:    NCT02513745
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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
Sponsor:
Collaborator:
Science in Vision
Information provided by (Responsible Party):
Carolina Eyecare Physicians, LLC

Brief 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.


Condition or disease Intervention/treatment Phase
Cataract Astigmatism Device: Conventional Device: Refractive Cataract Suite (Verion + ORA) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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.
Device: Conventional
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, South Carolina
Carolina Eyecare Physicians, LLC
Mount Pleasant, South Carolina, United States, 29464
Sponsors and Collaborators
Carolina Eyecare Physicians, LLC
Science in Vision
Investigators
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Principal Investigator: Kerry D Solomon, MD Carolina Eyecare Physicians, LLC
  Study Documents (Full-Text)

Documents provided by Carolina Eyecare Physicians, LLC:

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Responsible Party: Carolina Eyecare Physicians, LLC
ClinicalTrials.gov Identifier: NCT02513745     History of Changes
Other Study ID Numbers: CEP 2014-003
First Posted: August 3, 2015    Key Record Dates
Results First Posted: August 22, 2019
Last Update Posted: September 4, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Carolina Eyecare Physicians, LLC:
cataract
toric
phacoemulsification
Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors