Trial Outcomes & Findings for Conventional Surgery vs. Verion/VerifEye (NCT NCT02513745)
NCT ID: NCT02513745
Last Updated: 2019-09-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Three months
Results posted on
2019-09-04
Participant Flow
A total of 84 eyes of 42 patients were enrolled and started the study.
Unit of analysis: Eyes
Participant milestones
| Measure |
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Overall Study
STARTED
|
42 42
|
42 42
|
|
Overall Study
COMPLETED
|
39 39
|
39 39
|
|
Overall Study
NOT COMPLETED
|
3 3
|
3 3
|
Reasons for withdrawal
| Measure |
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Overall Study
Criteria at time of surgery not met.
|
3
|
3
|
Baseline Characteristics
Conventional Surgery vs. Verion/VerifEye
Baseline characteristics by cohort
| Measure |
Conventional
n=39 Eyes
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
Refractive Cataract Suite (Verion + ORA)
n=39 Eyes
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
Total
n=78 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.11 Years
STANDARD_DEVIATION 6.79 • n=14 Eyes
|
67.11 Years
STANDARD_DEVIATION 6.79 • n=23 Eyes
|
67.11 Years
STANDARD_DEVIATION 6.79 • n=50 Eyes
|
|
Sex: Female, Male
Female
|
26 Eyes
n=14 Eyes
|
26 Eyes
n=23 Eyes
|
52 Eyes
n=50 Eyes
|
|
Sex: Female, Male
Male
|
13 Eyes
n=14 Eyes
|
13 Eyes
n=23 Eyes
|
26 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Asian
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Black or African American
|
2 Eyes
n=14 Eyes
|
2 Eyes
n=23 Eyes
|
4 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
White
|
37 Eyes
n=14 Eyes
|
37 Eyes
n=23 Eyes
|
74 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
More than one race
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Eyes
n=14 Eyes
|
0 Eyes
n=23 Eyes
|
0 Eyes
n=50 Eyes
|
|
Region of Enrollment
United States
|
39 Eyes
n=14 Eyes
|
39 Eyes
n=23 Eyes
|
78 Eyes
n=50 Eyes
|
PRIMARY outcome
Timeframe: Three monthsThis is the manifest refractive cylinder measured 3 months after surgery. Note that because cataract surgery has been performed, there is no associated baseline value.
Outcome measures
| Measure |
Conventional
n=39 Participants
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
Refractive Cataract Suite (Verion + ORA)
n=39 Participants
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Residual Refractive Cylinder
|
0.28 Diopters
Standard Deviation 0.25
|
0.33 Diopters
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Three monthsThis 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.
Outcome measures
| Measure |
Conventional
n=39 Participants
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
Refractive Cataract Suite (Verion + ORA)
n=39 Participants
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Residual Mean Spherical Equivalent Refraction
|
0.06 Diopters
Standard Deviation 0.22
|
0.02 Diopters
Standard Deviation 0.31
|
SECONDARY outcome
Timeframe: Three monthsPopulation: This is a contra-lateral eye study where the first eye undergoing surgery was randomized to conventional or the refractive cataract suite, the fellow eye received the alternate treatment; therefore, we analyzed 78 eyes of 39 participants.
This is the anterior corneal astigmatism measured through keratometry. Note that because cataract surgery has been performed, there is no associated baseline value.
Outcome measures
| Measure |
Conventional
n=39 Participants
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
Refractive Cataract Suite (Verion + ORA)
n=39 Participants
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Residual Corneal Astigmatism
|
1.12 Diopters
Standard Deviation 0.71
|
1.16 Diopters
Standard Deviation 0.65
|
Adverse Events
Conventional
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Refractive Cataract Suite (Verion + ORA)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Conventional
n=39 participants at risk
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.
Conventional: Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
|
Refractive Cataract Suite (Verion + ORA)
n=39 participants at risk
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 +.
Verion: Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
|
|---|---|---|
|
Eye disorders
Irritation
|
0.00%
0/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
2.6%
1/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
|
Eye disorders
Worsening of dry eyes
|
2.6%
1/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
2.6%
1/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
|
Eye disorders
Retained lens fragments
|
2.6%
1/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
0.00%
0/39 • Adverse event data was collected from the moment the participant signed the consent until exited the study that is about 4 months.
|
Additional Information
Helga P. Sandoval, MD, MSCR. Director of Research
Carolina Eyecare Physicians, LLC
Phone: 8438813937
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place