Visual Outcomes and Patient Satisfaction With Vivity IOL in Post Refractive Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06064916

Enrollment

Registered

2023-10-03

Start date

2023-07-25

Completion date

2024-12-11

Last updated

2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pseudophakia

Keywords

Vivity, Pseudophakia

Brief summary

This is a non-interventional, prospective, observational study of the outcomes for post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*). Patients will be assessed for monocular and binocular distance, intermediate, and near vision.

Detailed description

This is a non-interventional, prospective, single center, bilateral, observational study of the outcomes for 40 post myopic refractive surgery patients following successful, uncomplicated cataract surgery with bilateral implantation of the Vivity IOL (DAT\*\*\*/CCWET\*) performed by 4 surgeons using similar surgical techniques. 40 subjects will be enrolled. Patients will be assessed for monocular and binocular distance, intermediate, and near vision. The hypothesis is that post-refractive patients that have high spherical aberration (SAs) will have excellent outcomes and satisfaction with a Vivity IOL

Interventions

DIAGNOSTIC_TESTVisual Acuity

Monocular and binocular measurement of distance, intermediate, and near visual acuity

DIAGNOSTIC_TESTDefocus Curve

Measurement of a defocus curve

OTHERIntraocular Lens Satisfaction (IOLSAT) Questionnaire

Self-reported post-operative patient satisfaction with vision after surgery

OTHERQuality of Vision After Surgery (QUVID) Questionnaire

Self-reported post-operative patient vision quality after surgery

OTHERVisual Disturbance Questionnaire

Questionnaire of self-reported visual disturbances of patients

DIAGNOSTIC_TESTTopography and Tomography

Topography and tomography measurements with Atlas, iTrace, and/or Pentacam

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Adults, 40 years of age having already undergone cataract removal by phacoemulsification with a clear corneal incision in both eyes with implantation of the Vivity IOL (DAT\*\*\*/CCWET\*) 2. Prior uncomplicated, distance-targeted, bilateral myopic LASIK or PRK (photorefractive keratectomy) surgery and corneal spherical aberration greater than ≥0.30 μ and ≤ 1.20 μ in at least one eye (6.00 mm) as measured at their cataract pre-op visit 3. Able to comprehend and willing to sign informed consent and complete all required testing procedures 4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better 5. Clear intraocular media 6. Minimum of two weeks post YAG (yttrium aluminum garnet) capsulotomy to treat PCO (posterior capsular opacification) 7. Residual refractive astigmatism ≤0.50 diopters 8. Post-operative refractive spherical equivalent from +0.50 to -0.50 spherical equivalent

Exclusion criteria

1. Any corneal abnormality, other than regular corneal astigmatism or myopic LASIK/PRK surgery, (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study 2. Any complication during cataract surgery (capsular tear, vitrectomy, etc) 3. History of or current retinal conditions or predisposition to retinal conditions or predisposition to retinal conditions 4. Amblyopia or strabismus in either eye 5. History of or current anterior or posterior segment inflammation of any etiology 6. Any form of neovascularization on or within the eye 7. Glaucoma (uncontrolled or controlled with medication) 8. Optic nerve atrophy 9. Subjects with diagnosed degenerative eye disorders 10. Postoperative CDVA worse than 0.10 logMAR in either eye. 11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the principal investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)

Design outcomes

Primary

Measure	Time frame	Description
Binocular Best Corrected Distance Visual Acuity	3 weeks post operatively	Binocular Best Corrected Distance Visual Acuity in logMAR

Secondary

Measure	Time frame	Description
Monocular Visual Acuity	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)
Binocular Distance, Intermediate, and Near Visual Acuity	3 weeks post operatively	Binocular distance (UDVA), intermediate (UIVA, DCIVA), and near visual acuity (UNVA, DCNVA)
Quality of Vision After Surgery (QUVID) Questionnaire	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.
Intraocular Lens Satisfaction (IOLSAT) Questionnaire	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.
Post-op Refraction	3 weeks post operatively	Manifest refraction spherical equivalent (MRSE)

Other

Measure	Time frame	Description
Binocular Defocus Curve	3 weeks post operatively	Binocular defocus curve (distance corrected)
Spectacle Independence (IOLSAT)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	20
Total	20

Arm

Count

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

Total

Baseline characteristics

Characteristic	Vivity IOL Group	—
Age, Continuous	68.0 years STANDARD_DEVIATION 6	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	9 Participants	—
Sex: Female, Male Male	11 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	0 / 20
serious Total, serious adverse events	0 / 20