CataractNCT05526781
Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
An observational study of Cataract, run by Eye Consultants of Atlanta at 1 site in United States.
Trial summary
To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia. 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 monofocal Intraocular lens (toric and non-toric models)
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2022to 12 Mar 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 participants will be presenting for cataract surgery and who are interested in and appropriate candidates for intraocular lens implantation.
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
- Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV.
- Able to provide written informed consent for participation in the study.
- All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV.
- Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
- History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
- History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
- History of rheumatoid arthritis, ocular cicatricial pemphigoid, or Steven's Johnson Syndrome.
Show all 9Show fewer
- History of glaucoma.
- 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.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.
Read the detailed description
This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.
- Conditions
- Cataract
- Being tested
- Clareon monofocal Intraocular lens (toric and non-toric models)
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon monofocal Intraocular lens (toric and non-toric models)Device
Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter
| Study group | Role | What they receive |
|---|---|---|
| Clareon® monofocal Intraocular lens (toric and non-toric models) | Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter Receives: Device: Clareon monofocal Intraocular lens (toric and non-toric models) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular Uncorrected Distance Visual Acuity (6m)
Measured: 3 months postoperative
Binocular Uncorrected Distance Visual Acuity (6m)
Measured: 3 months postoperative
Binocular Corrected Distance Visual Acuity (6m)
Measured: 3 months postoperative
Monocular Corrected Distance Visual Acuity (6m)
Measured: 3 months postoperative
Secondary outcomes (7)
Monocular Uncorrected Intermediate Visual Acuity (66cm)
Measured: 3 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (66cm)
Measured: 3 months postoperative
Binocular Distance Corrected Intermediate Visual Acuity (66cm)
Measured: 3 months postoperative
Monocular Distance Corrected Intermediate Visual Acuity (66cm)
Measured: 3 months postoperative
Manifest Refraction Spherical Equivalent (MRSE)
The percentage of eyes with MRSE within ± 0.5 D.
Measured: 3 months postoperative
Overall Surgeon Satisfaction of Monarch IV Delivery Experience
Score from 1-5. Higher scores indicate high surgeon satisfaction. Satisfaction was determined as the percentages of eyes where the surgeon was "Satisfied" or "Very Satisfied".
Measured: Operative visit (Day 0)
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV
Score from 1-4. Higher scores indicate higher consistency. Outcome measure is the percentage of eyes where the "IOL from cartridge coming out as planar, able to deliver IOL easily and smoothly into capsular bag".
Measured: Operative visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start21 Sep 2022
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Consultants of Atlanta
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Joesph Christenbury, MD, Principal investigator, Eye Consultants of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526781
- Sponsor's protocol ID
- JC-22-001
- Status last verified
- Mar 2025
- First submitted
- 30 Aug 2022
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes and Patient Satisfaction With Implantation of the Clareon Monofocal IOL With the New Clareon Manual Monarch IV IOL Delivery System
- ClinicalTrials.gov ID
- NCT05526781
- Acronym / sponsor ID
- JC-22-001
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eye Consultants of AtlantaUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate visual outcomes, in-the-bag placement and patient satisfaction in patients implanted with either Clareon monofocal or Clareon monofocal toric IOLs with the Monarch IV inserter and targeted for emmetropia.
Detailed description
This study is a single-arm clinical evaluation study of visual performance and patient satisfaction, after successful bilateral cataract surgery. Subjects will be assessed pre- operatively, operatively and at 1 month and 3 months post-operatively. Clinical evaluations will include measurement of bilateral visual acuity, manifest refraction, and IOLSAT questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clareon® monofocal Intraocular lens (toric and non-toric models) | – | Device: Clareon monofocal Intraocular lens (toric and non-toric models)Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be presenting for cataract surgery and who are interested in and appropriate candidates for intraocular lens implantation.
Key inclusion criteria (5 listed)
- Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
- Adult cataract surgical patients over the age of 45 with visually significant bilateral cataracts (glare visual acuity 20/40 or worse with BCVA testing), with planned cataract extraction using phacoemulsification, clear corneal incision and Clareon monofocal or Clareon toric with Monarch IV.
- Able to provide written informed consent for participation in the study.
- All eyes will be in the range of availability for Clareon monofocal and Clareon toric with Monarch IV.
- Expected visual potential of 20/25 Snellen (0.10 logMAR) or better in each eye.
Key exclusion criteria (9 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery.
- History of neovascular AMD, diabetic macular edema, unstable proliferative diabetic retinopathy, geographic atrophy, branch retinal artery or branch retinal vein occlusion, central retinal artery or central retinal vein occlusion, moderate to severe epiretinal membrane, severe dry eye.
- History of intraocular infection including HSV keratitis, VZV keratitis, endophthalmitis.
- History of previous ocular surgery, including corneal refractive surgery, eye trauma or retinal detachment surgery.
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 monofocal Intraocular lens (toric and non-toric models)Bilateral implantation of the Clareon monofocal Intraocular lens (toric and non-toric models) with the Monarch IV inserter | Device | Clareon® monofocal Intraocular lens (toric and non-toric models) |
Primary outcome
Monocular Uncorrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
Binocular Uncorrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
Binocular Corrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
Monocular Corrected Distance Visual Acuity (6m)
Time frame: 3 months postoperative
7 secondary outcomes
Monocular Uncorrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
Binocular Uncorrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
Binocular Distance Corrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
Monocular Distance Corrected Intermediate Visual Acuity (66cm)
Time frame: 3 months postoperative
Manifest Refraction Spherical Equivalent (MRSE)
Time frame: 3 months postoperative
Overall Surgeon Satisfaction of Monarch IV Delivery Experience
Time frame: Operative visit (Day 0)
Consistency of In-the-bag Delivery of IOL During Implantation With Monarch IV
Time frame: Operative visit (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Joesph Christenbury, MD principal investigator
Eye Consultants of Atlanta
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 Eye Consultants of Atlanta 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 9 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: finished, as of the sponsor's last update on 26 Mar 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?
Yes. Results are posted in the registry (first posted 26 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monocular Uncorrected Distance Visual Acuity (6m) (time frame: 3 months postoperative). The study lists 4 primary outcomes in all. 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 26 Mar 2025.