Trial Outcomes & Findings for Postmarket Study of an Intraocular Lens Power Selection System (NCT NCT03579433)

Last Updated: 2020-04-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

124 participants

Primary outcome timeframe

Month 6

Results posted on

2020-04-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	All Participants 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.
Overall Study STARTED	104
Overall Study ORA With VerifEye+	96
Overall Study Barrett Calculator	102
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postmarket Study of an Intraocular Lens Power Selection System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=104 Participants 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.
Age, Continuous	69.0 years STANDARD_DEVIATION 8.73 • n=5 Participants
Age, Customized Less than 65 years old	28 Participants n=5 Participants
Age, Customized 65 years old or older	76 Participants n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	102 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants

PRIMARY outcome

Timeframe: Month 6

Population: 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.

Outcome measures

Outcome measures
Measure	ORA With VerifEye+ n=85 eyes Acrysof® IQ Toric IOL and ORA with VerifEye+	Barrett Toric Calculator n=95 eyes Acrysof® IQ Toric IOL and Barrett Toric Calculator
Percentage of Eyes With Best Corrected Distance Visual Acuity (BCDVA) of 20/20 or Better at Month 6	87.1 percentage of eyes	87.4 percentage of eyes

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ORA With VerifEye+ Study Eye

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Barrett Toric Calculator Study Eye

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Overall Systemic

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=104 participants at risk All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye)	ORA With VerifEye+ Study Eye n=96 participants at risk All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+	Barrett Toric Calculator Study Eye n=102 participants at risk All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator	Overall Systemic n=104 participants at risk All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)
Eye disorders Metamorphopsia	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/96 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.98% 1/102 • Number of events 1 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Eye disorders Retinal detachment	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	1.0% 1/96 • Number of events 1 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/102 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Eye disorders Retinal tear	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	1.0% 1/96 • Number of events 1 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/102 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Reproductive system and breast disorders Vaginal prolapse	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/96 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/102 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.96% 1/104 • Number of events 1 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Surgical and medical procedures Eye laser surgery	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	2.1% 2/96 • Number of events 2 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/102 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Surgical and medical procedures Intraocular lens implant	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/96 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.98% 1/102 • Number of events 1 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Surgical and medical procedures Intraocular lens repositioning	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/96 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.98% 1/102 • Number of events 2 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."

Other adverse events

Other adverse events
Measure	Pretreatment n=104 participants at risk All subjects prior to with attempted implantation with any IOL (successful or aborted after contact with the eye)	ORA With VerifEye+ Study Eye n=96 participants at risk All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and ORA with VerifEye+	Barrett Toric Calculator Study Eye n=102 participants at risk All eyes with attempted implantation (successful or aborted after contact with the eye) of Acrysof® IQ Toric IOL and Barrett Toric Calculator	Overall Systemic n=104 participants at risk All subjects with attempted implantation with any IOL (successful or aborted after contact with the eye)
Eye disorders Posterior capsule opacification	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	5.2% 5/96 • Number of events 5 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	2.9% 3/102 • Number of events 3 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."
Investigations Intraocular pressure increased	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	7.3% 7/96 • Number of events 7 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	3.9% 4/102 • Number of events 4 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."	0.00% 0/104 • Adverse events were collected from time of attempted implantation with any IOL through study completion, an average of 120-180 days. 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."

Additional Information

Sr. CDMA Project Lead, Surgical

Alcon Research, LLC

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER