Evaluation of Quality of Vision and Spectacle Independence With the AcrySof® Panoptix® Intraocular Lens

• Sponsor: SightTrust Eye Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04124952
• Collaborator: Science in Vision (Other)
• Enrollment: 30
• Location: 1
• Actual Duration (Months): 16.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

This is a study to assess the spectacle independence and quality of vision of patients receiving the AcrySof® Panoptix® Intraocular lens (IOL) after uneventful cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: Panoptix

Detailed Description

This study is a single-arm unmasked clinical evaluation study of spectacle independence 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 spectacle independence questionnaire, as well as measurement of bilateral visual acuity and manifest refraction.

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Quality of Vision and Spectacle Independence With Bilateral Implantation of the AcrySof® Panoptix® Intraocular Lens
• Actual Study Start Date: Oct 3, 2019
• Actual Primary Completion Date: Feb 16, 2021
• Actual Study Completion Date: Feb 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Panoptix Patients bilaterally implanted with the Panoptix intraocular lens.	Device: Panoptix; Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)

Outcome Measures

Primary Outcome Measures

1. Number of Emmetropic Subjects Who Are Spectacle Independent [3 months]

   Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").

Secondary Outcome Measures

1. Binocular Uncorrected Distance Visual Acuity [3 months]

   Binocular logMAR uncorrected distance visual acuity

2. Binocular Uncorrected Intermediate Visual Acuity [3 months]

   Binocular logMAR uncorrected intermediate visual acuity

3. Binocular Uncorrected Near Visual Acuity [3 months]

   Binocular logMAR uncorrected near visual acuity

4. Binocular Corrected Distance Visual Acuity [3 months]

   Binocular logMAR corrected distance visual acuity

5. Binocular Distance-corrected Intermediate Visual Acuity [3 months]

   Binocular distance-corrected intermediate visual acuity in logMAR

6. Binocular Distance-corrected Near Visual Acuity [3 months]

   Binocular logMAR distance-corrected near visual acuity

7. Spherical Equivalent Refraction [3 months]

   Spherical equivalent refraction in diopters

8. Residual Refractive Cylinder [3 months]

   Residual refractive cylinder in diopters

9. Quality of Vision Questionnaire [3 months]

   Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.

10. Overall Spectacle Independence [3 months]

    percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the PRSIQ - "a little of the time" or "none of the time")

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria

Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

• Presenting for uncomplicated bilateral cataract surgery and have an interest in spectacle independence using a multifocal IOL or multifocal toric IOL option

• 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 a toric IOL in the approved ranged for the Panoptix lens.

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

Exclusion Criteria If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• 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, lamellar keratoplasty)

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

• Diabetic retinopathy

• Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)

• History of retinal detachment

• Subjects who have an 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).

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SightTrust Eye Institute	Sunrise	Florida	United States	33323

Sponsors and Collaborators

• SightTrust Eye Institute
• Science in Vision

Investigators

• Principal Investigator: Andrew C Shatz, MD, SightTrust Eye Institute

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 29, 2019

More Information

Publications

• McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
• Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.

• Responsible Party: SightTrust Eye Institute
• ClinicalTrials.gov Identifier: NCT04124952
• Other Study ID Numbers: AS-19-001
• First Posted: Oct 14, 2019
• Last Update Posted: Sep 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by SightTrust Eye Institute: Panoptix, trifocal IOL, multifocal IOL
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Period Title: Overall Study
STARTED	30
COMPLETED	29
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Overall Participants	29
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (7)
Sex: Female, Male (Count of Participants)
Female	17 58.6%
Male	12 41.4%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	29 100%

Outcome Measures

1. Primary Outcome

Title	Number of Emmetropic Subjects Who Are Spectacle Independent
Description	Number of patients who have a 3-month postoperative manifest spherical equivalent refraction within 0.5 diopters (D) of plano, and ≤ 0.5 D of refractive cylinder (emmetropic subgroup) who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire (PRSIQ) - "a little of the time" or "none of the time").
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

This is the number of emmetropic subjects (subgroup)

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	21
Count of Participants [Participants]	21 72.4%

2. Secondary Outcome

Title	Binocular Uncorrected Distance Visual Acuity
Description	Binocular logMAR uncorrected distance visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.07 (0.09)

3. Secondary Outcome

Title	Binocular Uncorrected Intermediate Visual Acuity
Description	Binocular logMAR uncorrected intermediate visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR]	0.09 (0.13)

4. Secondary Outcome

Title	Binocular Uncorrected Near Visual Acuity
Description	Binocular logMAR uncorrected near visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR Acuity]	0.07 (0.11)

5. Secondary Outcome

Title	Binocular Corrected Distance Visual Acuity
Description	Binocular logMAR corrected distance visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR Acuity]	0.03 (0.07)

6. Secondary Outcome

Title	Binocular Distance-corrected Intermediate Visual Acuity
Description	Binocular distance-corrected intermediate visual acuity in logMAR
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR Acuity]	0.06 (0.10)

7. Secondary Outcome

Title	Binocular Distance-corrected Near Visual Acuity
Description	Binocular logMAR distance-corrected near visual acuity
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [logMAR Acuity]	0.05 (0.11)

8. Secondary Outcome

Title	Spherical Equivalent Refraction
Description	Spherical equivalent refraction in diopters
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [diopters]	0.06 (0.53)

9. Secondary Outcome

Title	Residual Refractive Cylinder
Description	Residual refractive cylinder in diopters
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Mean (Standard Deviation) [diopters]	0.49 (0.36)

10. Secondary Outcome

Title	Quality of Vision Questionnaire
Description	Quality of Vision questionnaire results. This is a Rasch-scaled test with scores from 0-100, with lower being better.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Frequency	36.9 (16.6)
Severity	30.6 (15.1)
Degree of bother	28.7 (20.7)

11. Secondary Outcome

Title	Overall 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 PRSIQ - "a little of the time" or "none of the time")
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
Measure Participants	29
Count of Participants [Participants]	29 100%

Adverse Events

Time Frame	3 months
Arm/Group Title	Panoptix
Arm/Group Description	Patients bilaterally implanted with the Panoptix intraocular lens. Panoptix: Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
All Cause Mortality
	Panoptix
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Serious Adverse Events
	Panoptix
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Panoptix
	Affected / at Risk (%)	# Events
Total	1/30 (3.3%)
Musculoskeletal and connective tissue disorders
Bicycle accident	1/30 (3.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.