Postmarket Study of an Intraocular Lens Power Selection System

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

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 Disease	Intervention/Treatment	Phase
Cataract	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

Arm	Intervention/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

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Mount Dora	Florida	United States	32757
2	Alcon Investigative Site	Panama City	Florida	United States	32405
3	Alcon Investigative Site	Poughkeepsie	New York	United States	12603
4	Alcon Investigative Site	Kingston	Pennsylvania	United States	18704
5	Alcon Investigative Site	Florence	South Carolina	United States	29501
6	Alcon Investigative Site	Mount Pleasant	South Carolina	United States	29464
7	Alcon Investigative Site	Sioux Falls	South Dakota	United States	57108
8	Alcon Investigative Site	Nashville	Tennessee	United States	37205
9	Alcon Investigative Site	Nacogdoches	Texas	United States	75965

Sponsors and Collaborators

• Alcon Research

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Mar 20, 2019
• Statistical Analysis Plan - Mar 22, 2019

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: IOL; Intraocular lens; Astigmatism; Cataract Surgery
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Of 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.

Arm/Group Title	All Participants
Arm/Group Description	First 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
STARTED	104
ORA With VerifEye+	96
Barrett Calculator	102
COMPLETED	98
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	First 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 Participants	104
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

Title	Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6
Description	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.
Time Frame	Month 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 Title	ORA With VerifEye+	Barrett Toric Calculator
Arm/Group Description	Acrysof® IQ Toric IOL and ORA with VerifEye+	Acrysof® IQ Toric IOL and Barrett Toric Calculator
Measure Participants	85	95
Measure eyes	85	95
Number [percentage of eyes]	87.1	87.4

Adverse Events

Time Frame	Adverse 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 Title	Pretreatment		ORA With VerifEye+ Study Eye		Barrett Toric Calculator Study Eye		Overall Systemic
Arm/Group Description	All 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 Calculator		All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)
All Cause Mortality
	Pretreatment		ORA With VerifEye+ Study Eye		Barrett Toric Calculator Study Eye		Overall Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		0/96 (0%)		0/102 (0%)		0/104 (0%)
Serious Adverse Events
	Pretreatment		ORA With VerifEye+ Study Eye		Barrett Toric Calculator Study Eye		Overall Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		2/96 (2.1%)		2/102 (2%)		1/104 (1%)
Eye disorders
Metamorphopsia	0/104 (0%)	0	0/96 (0%)	0	1/102 (1%)	1	0/104 (0%)	0
Retinal detachment	0/104 (0%)	0	1/96 (1%)	1	0/102 (0%)	0	0/104 (0%)	0
Retinal tear	0/104 (0%)	0	1/96 (1%)	1	0/102 (0%)	0	0/104 (0%)	0
Reproductive system and breast disorders
Vaginal prolapse	0/104 (0%)	0	0/96 (0%)	0	0/102 (0%)	0	1/104 (1%)	1
Surgical and medical procedures
Eye laser surgery	0/104 (0%)	0	2/96 (2.1%)	2	0/102 (0%)	0	0/104 (0%)	0
Intraocular lens implant	0/104 (0%)	0	0/96 (0%)	0	1/102 (1%)	1	0/104 (0%)	0
Intraocular lens repositioning	0/104 (0%)	0	0/96 (0%)	0	1/102 (1%)	2	0/104 (0%)	0
Other (Not Including Serious) Adverse Events
	Pretreatment		ORA With VerifEye+ Study Eye		Barrett Toric Calculator Study Eye		Overall Systemic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/104 (0%)		10/96 (10.4%)		7/102 (6.9%)		0/104 (0%)
Eye disorders
Posterior capsule opacification	0/104 (0%)	0	5/96 (5.2%)	5	3/102 (2.9%)	3	0/104 (0%)	0
Investigations
Intraocular pressure increased	0/104 (0%)	0	7/96 (7.3%)	7	4/102 (3.9%)	4	0/104 (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.