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

Sponsor
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons (Other)
Overall Status
Recruiting
CT.gov ID
NCT05186298
Collaborator
(none)
320
Enrollment
5
Locations
2
Arms
5.9
Anticipated Duration (Months)
64
Patients Per Site
10.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: AcrySof® IQ PanOptix®
  • Device: Synergy®
  • Procedure: Cataract Surgery
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
320 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prospective Evaluation and Comparison of Bilateral Synergy Implants and Bilateral PanOptix Implants
Actual Study Start Date :
Nov 2, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AcrySof® IQ PanOptix® (Alcon Laboratories, Inc., Fort Worth, TX)

The subject will be implanted bilaterally during cataract surgery

Device: AcrySof® IQ PanOptix®
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

Procedure: Cataract Surgery
IOL implantation will be performed
Experimental: Synergy® (Johnson & Johnson Surgical Vision, Santa Ana, CA)

The subject will be implanted bilaterally during cataract surgery

Device: Synergy®
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.

Procedure: Cataract Surgery
IOL implantation will be performed

Outcome Measures

Primary Outcome Measures

  1. Binocular DCNVA [Up to Month 6]

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

Secondary Outcome Measures

  1. Visual Disturbances Evaluation [at all visits]

    Patient reported occurrences of visual disturbances of each group (unsolicited) at all visits

  2. Visual Disturbances Evaluation by Questionnaire (QUVID) [Up to Month 6]

    Patient reported visual disturbances by questionnaire (QUVID) postop

  3. BCDVA and DCIVA (60 cm) [Up to Month 6]

    Monocular and binocular BCDVA and DCIVA (60 cm) in both groups will be measured

  4. DCNVA (40 cm) [Up to Month 6]

    Monocular DCNVA (40 cm) in both groups will be measured

  5. Uncorrected Monocular and Binocular VA [Up to Month 6]

    Uncorrected monocular and binocular VA at distance, intermediate (60 cm) and near (40 cm)

  6. Visual Disturbances Evaluation by Questionnaire (IOL SAT) [Up to Month 6]

    Patient satisfaction of each group by questionnaire (IOL SAT) postop

  7. Defocus Curve [Up to Month 6]

    Defocus curve tested in binocular photopic conditions (+1.00 to -3.00 in 0.50D except +0.50 to -0.50 in 0.25D)

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Care Now Panama City Florida United States 32405
2 Seeta Eye Center Poughkeepsie New York United States 12603
3 Eye Care Specialists Kingston Pennsylvania United States 18704
4 Lehmann Eye Center Nacogdoches Texas United States 75965
5 Northwest Eye Surgeons Seattle Washington United States 98125

Sponsors and Collaborators

  • Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons

Investigators

  • Principal Investigator: Satish S Modi, MD, Seeta Eye Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alterman, Modi, & Wolter Ophthalmic Physicians & Surgeons
ClinicalTrials.gov Identifier:
NCT05186298
Other Study ID Numbers:
  • 68985013
First Posted:
Jan 11, 2022
Last Update Posted:
Jan 11, 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.:
No
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jan 11, 2022