NCT05186298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 2, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

January 11, 2022

Status Verified

January 1, 2022

Enrollment Period

6 months

First QC Date

November 16, 2021

Last Update Submit

January 10, 2022

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • Binocular DCNVA

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

    Up to Month 6

Secondary Outcomes (7)

  • Visual Disturbances Evaluation

    at all visits

  • Visual Disturbances Evaluation by Questionnaire (QUVID)

    Up to Month 6

  • BCDVA and DCIVA (60 cm)

    Up to Month 6

  • DCNVA (40 cm)

    Up to Month 6

  • Uncorrected Monocular and Binocular VA

    Up to Month 6

  • +2 more secondary outcomes

Study Arms (2)

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

EXPERIMENTAL

The subject will be implanted bilaterally during cataract surgery

Device: AcrySof® IQ PanOptix®Procedure: Cataract Surgery

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

EXPERIMENTAL

The subject will be implanted bilaterally during cataract surgery

Device: Synergy®Procedure: Cataract Surgery

Interventions

AcrySof® IQ PanOptix®DEVICE

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

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

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.

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

IOL implantation will be performed

AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Eye Care Now

Panama City, Florida, 32405, United States

RECRUITING

Seeta Eye Center

Poughkeepsie, New York, 12603, United States

RECRUITING

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

RECRUITING

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

RECRUITING

Northwest Eye Surgeons

Seattle, Washington, 98125, United States

RECRUITING

Related Publications (1)

  • Modi SS, Lehmann RP, Fisher BL, Roth RE, Reiser H. Comparison of visual function and patient-reported outcomes between two full range of field intraocular lenses: a randomized controlled study. J Cataract Refract Surg. 2025 Aug 1;51(8):695-702. doi: 10.1097/j.jcrs.0000000000001678.

    PMID: 40277405DERIVED

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Satish S Modi, MD

    Seeta Eye Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Satish S Modi, MD

CONTACT

845-454-1025smodieyes@aol.com

Sarah O Piza

CONTACT

845-454-1025sortiz523@aol.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

January 11, 2022

Study Start

November 2, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

January 11, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(5)