CataractNCT06555289
Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery
An observational study of Cataract, run by Juliette Eye Institute Research Center at 1 site in United States.
Trial summary
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon PanOptix Pro IOL
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Adult, Older adult
Study population: Eligible test subjects will be those with age-related cataracts and prior myopic refractive surgery.
Who may be able to join
- Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
- Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
- Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
- Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
- Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.
Who cannot join
- Any ocular comorbidity that might hamper postoperative visual acuity:
- Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
- Moderate or severe dry eyes that can't be relieved after treatment.
- History of or current anterior and posterior inflammation of any etiology.
- Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
- Glaucoma of any kind.
Show all 13Show fewer
- Pregnancy or lactation.
- Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
- Apple Kappa/chord mu ≥ 0.6.
- Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)
- Any patient requiring a limbal relaxing incision.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Juliette Eye Institute Research Center
Albuquerque, New Mexico, 87113
Zoe Baker, OD, 505-355-2020, dr.baker@julietteeye.com
Robert Melendez, MD, MBA
About this study
Official title: Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.
- Conditions
- Cataract
- Being tested
- Clareon PanOptix Pro IOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon PanOptix Pro IOLDevice
Spherical and toric T3
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular corrected distance visual acuity (logMAR)
Measured: 3 months postoperative
Secondary outcomes (5)
Binocular distance corrected visual acuity at intermediate (logMAR)
Measured: 3 months postoperative
Binocular distance corrected visual acuity at near (logMAR)
Measured: 3 months postoperative
Binocular unccorrected visual acuity at distance (logMAR)
Measured: 3 months postoperative
Binocular unccorrected visual acuity at intermediate (logMAR)
Measured: 3 months postoperative
Binocular unccorrected visual acuity at near (logMAR)
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start23 Oct 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juliette Eye Institute Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Robert Melendez, MD, MBA, Principal investigator, Juliette Eye Institute Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555289
- Sponsor's protocol ID
- RM-24-01
- Status last verified
- Dec 2025
- First submitted
- 13 Aug 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Refractive Outcomes of the Clareon PanOptix Pro IOL in Patients With Prior Myopic Refractive Surgery
- ClinicalTrials.gov ID
- NCT06555289
- Acronym / sponsor ID
- RM-24-01
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Juliette Eye Institute Research CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix Pro implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible test subjects will be those with age-related cataracts and prior myopic refractive surgery.
Key inclusion criteria (5 listed)
- Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
- Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
- Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix Pro spherical IOL.
- Patients who have regular corneal astigmatism and are candidates for PanOptix Pro toric IOL T3
- Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.
Key exclusion criteria (13 listed)
- Any ocular comorbidity that might hamper postoperative visual acuity:
- Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
- Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
- Apple Kappa/chord mu ≥ 0.6.
- Higher order corneal aberrations at pupil diameter of 4mm: > 0.6 total RMS, > 0.3 coma, > 0.3 trefoil (to exclude irregular corneas)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clareon PanOptix Pro IOLSpherical and toric T3 | Device | – |
Primary outcome
Binocular corrected distance visual acuity (logMAR)
Time frame: 3 months postoperative
5 secondary outcomes
Binocular distance corrected visual acuity at intermediate (logMAR)
Time frame: 3 months postoperative
Binocular distance corrected visual acuity at near (logMAR)
Time frame: 3 months postoperative
Binocular unccorrected visual acuity at distance (logMAR)
Time frame: 3 months postoperative
Binocular unccorrected visual acuity at intermediate (logMAR)
Time frame: 3 months postoperative
Binocular unccorrected visual acuity at near (logMAR)
Time frame: 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Melendez, MD, MBA principal investigator
Juliette Eye Institute Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Juliette Eye Institute Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe Baker, OD (505-355-2020, dr.baker@julietteeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular corrected distance visual acuity (logMAR) (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.