Postmarket Study of an Intraocular Lens Power Selection System

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT03579433
Collaborator
(none)
124
Enrollment
9
Locations
2
Arms
8
Actual Duration (Months)
13.8
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: ORA with VerifEye+
  • Other: Alcon Barrett Toric Calculator
  • Device: Acrysof® IQ Toric IOL
N/A

Detailed Description

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
124 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric
Actual Study Start Date :
Aug 16, 2018
Actual Primary Completion Date :
Apr 16, 2019
Actual Study Completion Date :
Apr 16, 2019

Arms and Interventions

ArmIntervention/Treatment
Experimental: ORA with VerifEye+

First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.

Device: ORA with VerifEye+
Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.

Device: Acrysof® IQ Toric IOL
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)

Active Comparator: Barrett Toric Calculator

First surgical eye randomly assigned to Acrysof® IQ Toric IOL and ORA with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.

Other: Alcon Barrett Toric Calculator
Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.

Device: Acrysof® IQ Toric IOL
Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)

Outcome Measures

Primary Outcome Measures

  1. Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6 [Month 6]

    Visual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Planned cataract surgery with IOL implantation

  • Able to comprehend and sign the informed consent form

  • Preoperative astigmatism of 0.75 to 3.00 Diopter

  • Willing and able to complete all required postoperative visits

  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:
  • Unclear intraocular media other than cataract

  • Pregnant or lactating

  • Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.

  • Other protocol-defined exclusion criteria may apply

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Alcon Investigative SiteMount DoraFloridaUnited States32757
2Alcon Investigative SitePanama CityFloridaUnited States32405
3Alcon Investigative SitePoughkeepsieNew YorkUnited States12603
4Alcon Investigative SiteKingstonPennsylvaniaUnited States18704
5Alcon Investigative SiteFlorenceSouth CarolinaUnited States29501
6Alcon Investigative SiteMount PleasantSouth CarolinaUnited States29464
7Alcon Investigative SiteSioux FallsSouth DakotaUnited States57108
8Alcon Investigative SiteNashvilleTennesseeUnited States37205
9Alcon Investigative SiteNacogdochesTexasUnited States75965

Sponsors and Collaborators

  • Alcon Research

Investigators

  • Study Director: Clinical Operations Lead, Surgical, Alcon Research, LLC

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03579433
Other Study ID Numbers:
  • ILX369-P001
First Posted:
Jul 6, 2018
Last Update Posted:
Apr 7, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Alcon Research
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment DetailsOf the 124 subjects enrolled, 12 subjects were discontinued prior to randomization, and 8 subjects were randomized, but not treated in either eye. This reporting group includes all subjects with attempted implantation of an intraocular lens (IOL) in one or both eyes.
Pre-assignment Detail
Arm/Group TitleAll Participants
Arm/Group DescriptionFirst surgical eye randomly assigned to Acrysof® IQ Toric IOL and Optiwave Refractive Analysis with VerifEye+ (ORA With VerifEye+) or Acrysof® IQ Toric IOL and Barrett Toric Calculator (Barrett Toric Calculator), with the second surgical eye (fellow eye) assigned to the alternative group.
Period Title: Overall Study
STARTED104
ORA With VerifEye+96
Barrett Calculator102
COMPLETED98
NOT COMPLETED6

Baseline Characteristics

Arm/Group TitleOverall
Arm/Group DescriptionFirst surgical eye randomly assigned to Acrysof® IQ Toric (IOL) and Optiwave Refractive Analysis (ORA) with VerifEye+ or Acrysof® IQ Toric IOL and Barrett Toric Calculator, with the second surgical eye (fellow eye) assigned to the alternative group.
Overall Participants104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
69.0
(8.73)
Age, Customized (Count of Participants)
Less than 65 years old
28
26.9%
65 years old or older
76
73.1%
Sex: Female, Male (Count of Participants)
Female
61
58.7%
Male
43
41.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
1.9%
Not Hispanic or Latino
102
98.1%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
1
1%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
7
6.7%
White
96
92.3%
More than one race
0
0%
Unknown or Not Reported
0
0%
Region of Enrollment (participants) [Number]
United States
104
100%

Outcome Measures

1. Primary Outcome
TitlePercentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
DescriptionVisual acuity (VA) was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast electronic Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a distance of 4 meters (m) from the eye. 20/20 represents normal distance eyesight. No hypothesis testing of the primary endpoint was specified.
Time FrameMonth 6

Outcome Measure Data

Analysis Population Description
The Per Protocol Analysis Set (PPS) includes all eyes with successful IOL implantation, T3-T6 and recommended by ORA and with no major protocol deviations and data at visit.
Arm/Group TitleORA With VerifEye+Barrett Toric Calculator
Arm/Group DescriptionAcrysof® IQ Toric IOL and ORA with VerifEye+Acrysof® IQ Toric IOL and Barrett Toric Calculator
Measure Participants8595
Measure eyes8595
Number [percentage of eyes]
87.1
87.4

Adverse Events

Time FrameAdverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days.
Adverse Event Reporting Description Adverse events were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. "At Risk" population for ocular adverse events is included with unit of "eyes."
Arm/Group TitlePretreatmentORA With VerifEye+ Study EyeBarrett Toric Calculator Study EyeOverall Systemic
Arm/Group DescriptionAll subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye)All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric CalculatorAll subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)
All Cause Mortality
PretreatmentORA With VerifEye+ Study EyeBarrett Toric Calculator Study EyeOverall Systemic
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/104 (0%) 0/96 (0%) 0/102 (0%) 0/104 (0%)
Serious Adverse Events
PretreatmentORA With VerifEye+ Study EyeBarrett Toric Calculator Study EyeOverall Systemic
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/104 (0%) 2/96 (2.1%) 2/102 (2%) 1/104 (1%)
Eye disorders
Metamorphopsia0/104 (0%) 00/96 (0%) 01/102 (1%) 10/104 (0%) 0
Retinal detachment0/104 (0%) 01/96 (1%) 10/102 (0%) 00/104 (0%) 0
Retinal tear0/104 (0%) 01/96 (1%) 10/102 (0%) 00/104 (0%) 0
Reproductive system and breast disorders
Vaginal prolapse0/104 (0%) 00/96 (0%) 00/102 (0%) 01/104 (1%) 1
Surgical and medical procedures
Eye laser surgery0/104 (0%) 02/96 (2.1%) 20/102 (0%) 00/104 (0%) 0
Intraocular lens implant0/104 (0%) 00/96 (0%) 01/102 (1%) 10/104 (0%) 0
Intraocular lens repositioning0/104 (0%) 00/96 (0%) 01/102 (1%) 20/104 (0%) 0
Other (Not Including Serious) Adverse Events
PretreatmentORA With VerifEye+ Study EyeBarrett Toric Calculator Study EyeOverall Systemic
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/104 (0%) 10/96 (10.4%) 7/102 (6.9%) 0/104 (0%)
Eye disorders
Posterior capsule opacification0/104 (0%) 05/96 (5.2%) 53/102 (2.9%) 30/104 (0%) 0
Investigations
Intraocular pressure increased0/104 (0%) 07/96 (7.3%) 74/102 (3.9%) 40/104 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.

Results Point of Contact

Name/TitleSr. CDMA Project Lead, Surgical
OrganizationAlcon Research, LLC
Phone1-888-451-3937
Emailalcon.medinfo@alcon.com
Responsible Party:
Alcon Research
ClinicalTrials.gov Identifier:
NCT03579433
Other Study ID Numbers:
  • ILX369-P001
First Posted:
Jul 6, 2018
Last Update Posted:
Apr 7, 2020
Last Verified:
Apr 1, 2020