Evaluation of Vision After Vivity IOL Implantation With a Target of Slight Myopia in the Non-dominant Eye

• Sponsor: Newsom Eye & Laser Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04482439
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The objective is to assess binocular distance-corrected near (40 cm) visual acuity of patients after uneventful cataract surgery with bilateral implantation of the AcrySof® Vivity Intraocular lens (IOL) when the non-dominant eye is targeted for slight myopia.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Vivity Extended Depth of Focus intraocular lens (IOL)	N/A

Detailed Description

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), patient-reported spectacle independence questionnaire (PRSIQ), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected near (40 cm) visual acuity, when the non-dominant eye is targeted for slight myopia, after successful bilateral cataract surgery.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the AcrySof® Vivity Intraocular Lens With a Target of Slight Myopia in the Non-dominant Eye
• Actual Study Start Date: Jul 17, 2020
• Actual Primary Completion Date: Jun 10, 2021
• Actual Study Completion Date: Jun 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vivity mini-monovision Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye.	Device: Vivity Extended Depth of Focus intraocular lens (IOL); Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.

Outcome Measures

Primary Outcome Measures

1. Binocular Near Visual Acuity [3 months postop]

   binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.

Secondary Outcome Measures

1. Prediction Accuracy [3 months postop]

   Percentage of eyes with postoperative refractive accuracy within 0.5D of target

2. Spectacle Independence [3 months postop]

   Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")

3. Patient Spectacle Independence [3 months postop]

   Patients reporting rarely or never needing glasses overall

4. Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely" [3 months postop]

   This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.

5. Manifest Refraction [3 months postop]

   Manifest refraction (residual spherical equivalent refraction)

6. Residual Cylinder [3 months]

   Residual refractive cylinder after surgery

7. Uncorrected Distance Visual Acuity [3 months postop]

   Bilateral uncorrected distance visual acuity

8. Uncorrected Intermediate Visual Acuity [3 months postop]

   Bilateral uncorrected visual acuity at 66 cm

9. Uncorrected Near Visual Acuity [3 months postop]

   Bilateral uncorrected near visual acuity at 40 cm

10. Corrected Distance Visual Acuity [3 months postop]

    Bliateral corrected distance visual acuity

11. Distance Corrected Intermediate Visual Acuity [3 months postop]

    Bliateral distance corrected visual acuity at 66 cm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• • Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using an EDF IOL

• Meet the requirements for on-label implantation of the EDF IOL

• Gender: Males and Females.

• Age: 40 or older.

• Willing and able to provide written informed consent for participation in the study.

• Willing and able to comply with scheduled visits and other study procedures.

• Have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)

• Have regular corneal astigmatism with a magnitude that can be treated with a non-toric IOL or toric IOL.

• Have 20/32 (0.2 logMAR) or better potential acuity in both eyes

Exclusion Criteria:

• • Irregular astigmatism (e.g. keratoconus)

• Corneal pathology (e.g. scar, dystrophy, pterygium, severe dry eye)

• Monocular status (e.g. amblyopia)

• Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, DSAEK, lamellar keratoplasty)

• Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)

• Diabetic retinopathy

• Macular pathology (e.g. ARMD, ERM)

• History of retinal detachment

• Subjects who have an unstable acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.

• Participation in any investigational drug or device trial within the previous 30 days prior to the start date of this trial (or currently participating).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Newsom Eye and Laser Center	Sebring	Florida	United States	33870

Sponsors and Collaborators

• Newsom Eye & Laser Center

Investigators

• Principal Investigator: Thomas Newsom, MD, Newsom Eye & Laser Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 2, 2020

More Information

Publications

None provided.

• Responsible Party: Newsom Eye & Laser Center
• ClinicalTrials.gov Identifier: NCT04482439
• Other Study ID Numbers: TN-20-001
• First Posted: Jul 22, 2020
• Last Update Posted: Mar 3, 2022
• Last Verified: Jan 1, 2022

• 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
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Period Title: Overall Study
STARTED	35
COMPLETED	33
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Overall Participants	33
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (5.5)
Sex: Female, Male (Count of Participants)
Female	21 63.6%
Male	12 36.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	Binocular Near Visual Acuity
Description	binocular distance-corrected near (40 cm) visual acuity at 3 months postoperative.
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0.14 (0.10)

2. Secondary Outcome

Title	Prediction Accuracy
Description	Percentage of eyes with postoperative refractive accuracy within 0.5D of target
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Measure Eyes	66
Count of Units [Eyes]	56

3. Secondary Outcome

Title	Spectacle Independence
Description	Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire - "a little of the time" or "none of the time")
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

All subjects who completed 3M PRSIQ questionnaire successfully

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	32
Count of Participants [Participants]	26 78.8%

4. Secondary Outcome

Title	Patient Spectacle Independence
Description	Patients reporting rarely or never needing glasses overall
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Count of Participants [Participants]	23 69.7%

5. Secondary Outcome

Title	Number of Participants Rating Frequency of Visual Disturbances as "Never" or "Rarely"
Description	This is the frequency of subjects responding, "Never" or "Rarely" to a question about the frequency of glare, halos and starbursts.
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Glare frequency "never" or 'rarely"	19 57.6%
Halos frequency "never" or "rarely"	18 54.5%
Starbursts frequency "never" or "rarely"	13 39.4%

6. Secondary Outcome

Title	Manifest Refraction
Description	Manifest refraction (residual spherical equivalent refraction)
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

Each subject had 1 eye targeted for plano, and one eye targeted for myopia. So, each row includes 33 eyes of 33 subjects.

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Measure Eyes	66
Eyes targeted for plano	.01 (.31)
Eyes targeted for myopia	-.74 (0.39)

7. Secondary Outcome

Title	Residual Cylinder
Description	Residual refractive cylinder after surgery
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Mini-monovision
Arm/Group Description	Subjects will have bilateral Vivity IOL implanted, with a target of slight myopia in the non-dominant eye. Vivity Extended Depth of Focus intraocular lens (IOL): Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
Measure Participants	33
Measure Eyes	66
Mean (Standard Deviation) [diopters]	0.42 (0.30)

8. Secondary Outcome

Title	Uncorrected Distance Visual Acuity
Description	Bilateral uncorrected distance visual acuity
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0.02 (0.09)

9. Secondary Outcome

Title	Uncorrected Intermediate Visual Acuity
Description	Bilateral uncorrected visual acuity at 66 cm
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0 (.07)

10. Secondary Outcome

Title	Uncorrected Near Visual Acuity
Description	Bilateral uncorrected near visual acuity at 40 cm
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0.12 (0.1)

11. Secondary Outcome

Title	Corrected Distance Visual Acuity
Description	Bliateral corrected distance visual acuity
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0.01 (0.08)

12. Secondary Outcome

Title	Distance Corrected Intermediate Visual Acuity
Description	Bliateral distance corrected visual acuity at 66 cm
Time Frame	3 months postop

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
Measure Participants	33
Mean (Standard Deviation) [logMAR]	0.02 (0.06)

Adverse Events

Time Frame	Surgery to 3 months
Arm/Group Title	Vivity Monovision Group
Arm/Group Description	Eyes bilaterally implanted with Vivity IOL with non-dominant eye targeted for -0.75D of myopia.
All Cause Mortality
	Vivity Monovision Group
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Serious Adverse Events
	Vivity Monovision Group
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	Vivity Monovision Group
	Affected / at Risk (%)	# Events
Total	0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.