search
Back to results

Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

Primary Purpose

Cataract

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AcrySof® IQ PanOptix®
Synergy®
Cataract Surgery
Sponsored by
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Note: Ocular criteria must be met in both eyes.

  • are willing and able to understand and sign an informed consent;
  • are willing and able to attend all study visits;
  • Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted
  • Clear intraocular media other than cataracts.
  • Projected BCDVA of better than 0.10 logMAR.
  • Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes
  • Biometer IOL calculations within +6.0 - +30.0 power range

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.

  • Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity
  • Glaucoma or Ocular Hypertension
  • Planned multiple procedures (eg MIGS)
  • Amblyopia, Strabismus
  • Patient's IOL calculation that are outside the range of available lenses
  • Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK)
  • Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes
  • Diabetic retinopathy if the investigator feels this will compromise visual outcomes
  • Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes
  • History of retinal detachment
  • If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk)
  • 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 post-operative visual acuity.

Sites / Locations

  • Eye Care NowRecruiting
  • Seeta Eye CenterRecruiting
  • Eye Care SpecialistsRecruiting
  • Lehmann Eye CenterRecruiting
  • Northwest Eye SurgeonsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)

Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)

Arm Description

The subject will be implanted bilaterally during cataract surgery

The subject will be implanted bilaterally during cataract surgery

Outcomes

Primary Outcome Measures

Binocular DCNVA
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm

Secondary Outcome Measures

Visual Disturbances Evaluation
Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits
Visual Disturbances Evaluation by Questionnaire (QUVID)
Patient reported visual disturbances by questionnaire (QUVID) postop
BCDVA and DCIVA (60 cm)
Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured
DCNVA (40 cm)
Monocular DCNVA (40 cm) in both groups will be measured
Uncorrected Monocular and Binocular VA
Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)
Visual Disturbances Evaluation by Questionnaire (IOL SAT)
Patient satisfaction of each group by questionnaire (IOL SAT) postop
Defocus Curve
Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)

Full Information

First Posted
November 16, 2021
Last Updated
January 10, 2022
Sponsor
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
search

1. Study Identification

Unique Protocol Identification Number
NCT05186298
Brief Title
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Official Title
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2021 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

4. Oversight

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.
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the AcrySof PanOptix Intraocular Lens (IOL) for binocular distance corrected near visual acuity (DCNVA) compared to TECNIS Synergy IOL. Presbyopia correcting diffractive intraocular implants (extended depth of focus, multifocal, and trifocal) provide cataract and refractive surgeons with an effective treatment means for allowing patients to experience increased spectacle independence post-cataract surgery.
Detailed Description
Eligible test subjects will be patients diagnosed with cataracts bilaterally who are interested and eligible for implantation of a presbyopia-correcting multifocal intraocular lenses. Subjects will participate in ten study visits. Visits will include a screening visit (both eyes evaluated), one operative visit for each eye, and 7 postoperative visits. Both eyes will be implanted, with the second eye surgery occurring X (depends on the patient and the schedule) days after the first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)
Arm Type
Experimental
Arm Description
The subject will be implanted bilaterally during cataract surgery
Arm Title
Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)
Arm Type
Experimental
Arm Description
The subject will be implanted bilaterally during cataract surgery
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ PanOptix®
Intervention Description
The AcrySof IQ PanOptix® (Alcon) mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity with a reduced need for eyeglasses, compared to a monofocal IOL
Intervention Type
Device
Intervention Name(s)
Synergy®
Intervention Description
The TECNIS Synergy™ IOLs mitigate the effects of presbyopia by providing far vision comparable to an aspheric monofocal IOL. Compared to an aspheric monofocal IOL, the lens provides significantly improved intermediate and near vision, including in low-light conditions.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
IOL implantation will be performed
Primary Outcome Measure Information:
Title
Binocular DCNVA
Description
Binocular DCNVA of Trifocal (Alcon Panoptix) versus EDOF/Bifocal (Johnson and Johnson Tecnis Synergy) at 40 cm
Time Frame
Up to Month 6
Secondary Outcome Measure Information:
Title
Visual Disturbances Evaluation
Description
Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits
Time Frame
at all visits
Title
Visual Disturbances Evaluation by Questionnaire (QUVID)
Description
Patient reported visual disturbances by questionnaire (QUVID) postop
Time Frame
Up to Month 6
Title
BCDVA and DCIVA (60 cm)
Description
Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured
Time Frame
Up to Month 6
Title
DCNVA (40 cm)
Description
Monocular DCNVA (40 cm) in both groups will be measured
Time Frame
Up to Month 6
Title
Uncorrected Monocular and Binocular VA
Description
Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)
Time Frame
Up to Month 6
Title
Visual Disturbances Evaluation by Questionnaire (IOL SAT)
Description
Patient satisfaction of each group by questionnaire (IOL SAT) postop
Time Frame
Up to Month 6
Title
Defocus Curve
Description
Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)
Time Frame
Up to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Note: Ocular criteria must be met in both eyes. are willing and able to understand and sign an informed consent; are willing and able to attend all study visits; Subjects diagnosed with bilateral cataracts with planned cataract removal by femto assisted phacoemulsification with a clear corneal incision and intraoperative aberrometry assisted Clear intraocular media other than cataracts. Projected BCDVA of better than 0.10 logMAR. Preoperative regular keratometric astigmatism (by biometer) of less than or equal to 0.75D, in both eyes Biometer IOL calculations within +6.0 - +30.0 power range 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. Clinically significant corneal abnormality, irregularity, inflammation, or edema aberrations, corneal disease, degeneration, or conditions affecting postoperative visual acuity Glaucoma or Ocular Hypertension Planned multiple procedures (eg MIGS) Amblyopia, Strabismus Patient's IOL calculation that are outside the range of available lenses Prior corneal refractive surgery or other corneal surgery (e.g., corneal transplant, lamellar keratoplasty, LASIK, PRK) Previous anterior or posterior chamber surgery (e.g., vitrectomy) that the investigator feels may compromise visual outcomes Diabetic retinopathy if the investigator feels this will compromise visual outcomes Macular Pathology (i.e., ERM, ARMD, DMR etc.) if the investigator feels this will compromise visual outcomes History of retinal detachment If, in the surgeon's opinion, the subject is not an appropriate candidate for multifocal IOL implantation (eg. patients who are professional night drivers or pilots, and those with other occupations for whom induces dysphotopsias could put their career at risk) 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 post-operative visual acuity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Satish S Modi, MD
Phone
845-454-1025
Email
smodieyes@aol.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah O Piza
Phone
845-454-1025
Email
sortiz523@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Satish S Modi, MD
Organizational Affiliation
Seeta Eye Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Care Now
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bret Fisher, M.D.
Email
cmenck@eyecarenow.com
First Name & Middle Initial & Last Name & Degree
Bret Fisher, M.D.
Facility Name
Seeta Eye Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12603
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satish S Modi, MD
Email
spiza@seetaeye.com
First Name & Middle Initial & Last Name & Degree
Satish S Modi, MD
Facility Name
Eye Care Specialists
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Roth, D.O.
Email
patti.myers@vipeyes.com
First Name & Middle Initial & Last Name & Degree
Richard Roth, D.O.
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Lehmann, M.D.
Email
olucas@lehmanneyecenter.com
First Name & Middle Initial & Last Name & Degree
Robert Lehmann, M.D.
Facility Name
Northwest Eye Surgeons
City
Seattle
State/Province
Washington
ZIP/Postal Code
98125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey T Rostov, M.D.
Email
hannah.seo@nweyes.com
First Name & Middle Initial & Last Name & Degree
Audrey T Rostov, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants

We'll reach out to this number within 24 hrs