RECRUITING

Visual Performance of Clareon PanOptix vs. a Comparable Multifocal Intraocular Lens

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a two-part, multi-center, investigator-initiated clinical study comparing visual outcomes and patient satisfaction in subjects receiving bilateral implantation of either the Clareon PanOptix intraocular lens (IOL) or a comparable multifocal IOL. The study includes a retrospective/prospective pilot phase and a prospective, randomized comparison phase.

Official Title

Visual Performance Differences Between Clareon PanOptix and a Comparable Multifocal Intraocular Lens

Quick Facts

Study Start:2025-05-07

Study Completion:2025-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07006428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Willing and able to understand and sign informed consent. * Adult patients previously diagnosed with age-related cataracts bilaterally. * Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and \>2 weeks post YAG (if done) that were targeted for emmetropia. * Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon. * Normal ocular findings aside from cataract. * Willing and able to understand and sign informed consent. * Adult patient diagnosed with age-related cataracts bilaterally. * Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4). * Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon. * Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (after using either toric IOL or arcuate incision with laser). * Normal ocular findings aside from cataract.	* Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery including corneal refractive surgery. * Participation in another clinical study that could interfere with the results. * Patients with monovision correction. * Any active ocular infection or inflammation. * Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative * diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery including corneal refractive surgery. * Participants desiring monovision. * History of amblyopia or monofixation syndrome with poor stereoscopic vision. * Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography. * Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs). * Participation in another clinical study that could interfere with the results. * Any active ocular infection or inflammation.

Inclusion Criteria

Exclusion Criteria

* Willing and able to understand and sign informed consent.
* Adult patients previously diagnosed with age-related cataracts bilaterally.
* Previous bilateral age-related cataract removal and with bilateral implantation of the Clareon PanOptix/ Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4) closest to 2.5-5-months after implantation and \>2 weeks post YAG (if done) that were targeted for emmetropia.
* Best monocular corrected distance visual acuity was expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon.
* Normal ocular findings aside from cataract.
* Willing and able to understand and sign informed consent.
* Adult patient diagnosed with age-related cataracts bilaterally.
* Planned bilateral cataract removal by femtosecond laser-assisted phacoemulsification with bilateral implantation of the Clareon PanOptix/Clareon PanOptix Toric (T3-T4) or Comparable Multifocal Intraocular Lens (equivalent to T3-T4).
* Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes postoperatively as determined by surgeon.
* Residual astigmatism expected to be ≤ 0.50 diopters in both eyes postoperatively as determined by surgeon (after using either toric IOL or arcuate incision with laser).
* Normal ocular findings aside from cataract.

* Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
* Previous history of any ocular surgery including corneal refractive surgery.
* Participation in another clinical study that could interfere with the results.
* Patients with monovision correction.
* Any active ocular infection or inflammation.
* Corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative
* diseases that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
* Previous history of any ocular surgery including corneal refractive surgery.
* Participants desiring monovision.
* History of amblyopia or monofixation syndrome with poor stereoscopic vision.
* Total corneal HOA greater than 0.6um, coma less than 0.3um at 4mm-5mm scan depending on pre- op photopic topography.
* Any planned simultaneous/combined procedures at time of cataract surgery (e.g. MIGs).
* Participation in another clinical study that could interfere with the results.
* Any active ocular infection or inflammation.

Contacts and Locations

Study Locations (Sites)

Wolstan & Goldberg Eye Associates

Torrance, California, 90505

United States

Tyson Eye

Cape Coral, Florida, 33904

United States

North Georgia Eye Associates

Gainesville, Georgia, 30501

United States

Collaborators and Investigators

Sponsor: Argus Research Center, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07

Study Completion Date2025-11

Study Record Updates

Study Start Date2025-05-07

Study Completion Date2025-11

Terms related to this study

Keywords Provided by Researchers

Clareon PanOptix
Multifocal IOL
Cataract Surgery
Visual Acuity
Intraocular Lens

Additional Relevant MeSH Terms

Age Related Cataracts