Trial Outcomes & Findings for Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients (NCT NCT06064916)

NCT ID: NCT06064916

Last Updated: 2025-05-23

Results Overview

Binocular Best Corrected Distance Visual Acuity in logMAR

• Recruitment status: COMPLETED
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 weeks post operatively
• Results posted on: 2025-05-23

Participant Flow

Unit of analysis: eyes

Participant milestones

Measure	Vivity IOL Group Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Overall Study STARTED	20 40
Overall Study COMPLETED	20 40
Overall Study NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Age, Continuous	68.0 years STANDARD_DEVIATION 6.0 • n=20 Participants
Sex: Female, Male Female	9 Participants n=20 Participants
Sex: Female, Male Male	11 Participants n=20 Participants

PRIMARY outcome

Timeframe: 3 weeks post operatively

Binocular Best Corrected Distance Visual Acuity in logMAR

Outcome measures

Measure

Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Binocular Best Corrected Distance Visual Acuity

-0.05 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: 3 weeks post operatively

Monocular UDVA (uncorrected distance visual acuity), UIVA (uncorrected intermediate visual acuity), UNVA (uncorrected near visual acuity), and CDVA (corrected distance visual acuity)

Outcome measures

Measure	Vivity IOL Group n=40 eyes Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Monocular Visual Acuity UDVA	0.06 logMAR Standard Deviation 0.11
Monocular Visual Acuity UIVA	0.18 logMAR Standard Deviation 0.12
Monocular Visual Acuity UNVA	0.31 logMAR Standard Deviation 0.19
Monocular Visual Acuity CDVA	0.00 logMAR Standard Deviation 0.08

SECONDARY outcome

Timeframe: 3 weeks post operatively

Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)

Outcome measures

Measure	Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Binocular Distance, Intermediate, and Near Visual Acuity UDVA	0.02 logMAR Standard Deviation 0.16
Binocular Distance, Intermediate, and Near Visual Acuity UIVA	0.14 logMAR Standard Deviation 0.13
Binocular Distance, Intermediate, and Near Visual Acuity DCIVA	0.11 logMAR Standard Deviation 0.11
Binocular Distance, Intermediate, and Near Visual Acuity UNVA	0.24 logMAR Standard Deviation 0.14
Binocular Distance, Intermediate, and Near Visual Acuity DCNVA	0.25 logMAR Standard Deviation 0.15

SECONDARY outcome

Timeframe: 3 weeks post operatively

Patient reported disphotopsias by QUVID questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of subjects that answered "Never" or "Rarely" for frequency are provided.

Outcome measures

Measure	Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Quality of Vision After Surgery (QUVID) Questionnaire Starburst	11 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Halos	13 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Glare	9 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Haze	15 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Blurred Vision	15 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Double Vision	19 Participants
Quality of Vision After Surgery (QUVID) Questionnaire Dark Area	20 Participants

SECONDARY outcome

Timeframe: 3 weeks post operatively

Patient reported satisfaction by IOLSAT questionnaire will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. The percentage of patients "Satisfied" or "Very Satisfied" will be added for a total satisfaction percentage.

Outcome measures

Measure

Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Intraocular Lens Satisfaction (IOLSAT) Questionnaire

16 Participants

SECONDARY outcome

Timeframe: 3 weeks post operatively

Manifest refraction spherical equivalent (MRSE)

Outcome measures

Measure

Vivity IOL Group n=40 eyes Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Post-op Refraction

-0.11 D Standard Deviation 0.31

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks post operatively

Binocular defocus curve (distance corrected)

Outcome measures

Measure	Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Binocular Defocus Curve 1.00 D	0.11 logMAR Standard Deviation 0.10
Binocular Defocus Curve -3.00 D	0.39 logMAR Standard Deviation 0.17
Binocular Defocus Curve -2.50 D	0.26 logMAR Standard Deviation 0.17
Binocular Defocus Curve -2.00 D	0.17 logMAR Standard Deviation 0.13
Binocular Defocus Curve -1.50 D	0.05 logMAR Standard Deviation 0.12
Binocular Defocus Curve -1.00 D	0.03 logMAR Standard Deviation 0.11
Binocular Defocus Curve -0.50 D	0.00 logMAR Standard Deviation 0.11
Binocular Defocus Curve -0.25 D	-0.05 logMAR Standard Deviation 0.09
Binocular Defocus Curve 0.00 D	-0.06 logMAR Standard Deviation 0.09
Binocular Defocus Curve 0.25 D	-0.02 logMAR Standard Deviation 0.10
Binocular Defocus Curve 0.50 D	0.00 logMAR Standard Deviation 0.10

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 weeks post operatively

Spectacle independence utilizing the IOLSAT will be assessed. Variables measured on a categorical scale will be summarized to provide the number and percentage of subjects who provided each score. Spectacle independence was defined as answering "Never" or "Rarely" on the IOLSAT, the data presented is the percentage of subjects answering "Never" or "Rarely".

Outcome measures

Measure	Vivity IOL Group n=20 Participants Patients with bilateral implantation of Vivity IOLs. Visual Acuity: Monocular and binocular measurement of distance, intermediate, and near visual acuity Defocus Curve: Measurement of a defocus curve Intraocular Lens Satisfaction (IOLSAT) Questionnaire: Self-reported post-operative patient satisfaction with vision after surgery Quality of Vision After Surgery (QUVID) Questionnaire: Self-reported post-operative patient vision quality after surgery Visual Disturbance Questionnaire: Questionnaire of self-reported visual disturbances of patients Topography and Tomography: Topography and tomography measurements with Atlas, iTrace, and/or Pentacam
Spectacle Independence (IOLSAT) Overall	90 percentage of participants
Spectacle Independence (IOLSAT) Distance	90 percentage of participants
Spectacle Independence (IOLSAT) Intermediate	75 percentage of participants
Spectacle Independence (IOLSAT) Near	30 percentage of participants

Adverse Events

Vivity IOL Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tetiana Huff

Berkeley Eye Center

Phone: 713-620-7640

Email: tetiana.huff@berkeleyeye.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place