CataractNCT06122103
Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
An observational study of Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon Monofocal and Light-Adjustable Lens
- Type of treatment
- Medical device
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2023to 10 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible participants will be adult normal astigmatic (≥ 0.75D corneal astigmatism) cataract patients presenting for cataract surgery who are considered 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 patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
- Regular corneal astigmatism of 0.75D-2.50D
- Dilated pupil diameter of 7mm or greater
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.
- Moderate-severe 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, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- History of corneal refractive and intraocular surgery.
- Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.
- 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.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
This study is a single center, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
- Conditions
- Cataract
- Being tested
- Clareon Monofocal, Light-Adjustable Lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon MonofocalDevice
Clareon Monofocal Intraocular Lens (toric and non-toric)
Light-Adjustable LensDevice
Light-Adjustable Lens (Intraocular Lens)
| Study group | Role | What they receive |
|---|---|---|
| Clareon Monofocal | Not described Receives: Device: Clareon Monofocal | |
| Light-Adjustable Lens | Not described Receives: Device: Light-Adjustable Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Corrected Distance Visual Acuity (CDVA)
Measured: 3 months postop
Secondary outcomes (7)
Binocular Uncorrected Distance Visual Acuity (UDVA)
Measured: 3 months postop
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measured: 3 months postop
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Measured: 3 months postop
Monocular Corrected Distance Visual Acuity (CDVA)
Measured: 3 months postop
Monocular Uncorrected Distance Visual Acuity (UDVA)
Measured: 3 months postop
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measured: 3 months postop
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Measured: 3 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start21 Nov 2023
- Primary completion10 Feb 2025
- Study completion10 Feb 2025
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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Clayton G Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06122103
- Sponsor's protocol ID
- CB-23-02
- Status last verified
- Jan 2026
- First submitted
- 3 Nov 2023
- Last updated
- 28 Jan 2026
- 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 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual Outcomes With Mini-Monovision Between a Monofocal and an Adjustable Intraocular Lens
- ClinicalTrials.gov ID
- NCT06122103
- Acronym / sponsor ID
- CB-23-02
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 10 Feb 2025 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Posted 28 Jan 2026
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, multi-surgeon, prospective, randomized, comparative study of binocular corrected distance visual acuity (CDVA) after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at up to 6 postoperative visits. Clinical evaluations will include administration of patient reported spectacle usage questionnaire (PRSIQ), as well as measurement of monocular and binocular visual acuities at distance, intermediate, and near, defocus curve, manifest refraction, measurement of higher order aberrations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon Monofocal | – | Device: Clareon Monofocal |
| Light-Adjustable Lens | – | Device: Light-Adjustable Lens |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible participants will be adult normal astigmatic (≥ 0.75D corneal astigmatism) cataract patients presenting for cataract surgery who are considered appropriate candidates for intraocular lens implantation.
Key inclusion criteria (4 listed)
- Subjects are eligible for the study if they meet the following criteria: Note: Ocular criteria must be met in both eyes.
- Adult patients undergoing age-related cataract surgery with expected best- corrected visual outcomes of 20/25 or better
- Regular corneal astigmatism of 0.75D-2.50D
- Dilated pupil diameter of 7mm or greater
Key exclusion criteria (6 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.
- Moderate-severe 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, history of uveitis, ocular herpes simplex virus, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation.
- History of corneal refractive and intraocular surgery.
- Patients taking systemic medication that may increase sensitivity to UV light or that may cause toxicity to the retina.
- 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.
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 MonofocalClareon Monofocal Intraocular Lens (toric and non-toric) | Device | Clareon Monofocal |
| Light-Adjustable LensLight-Adjustable Lens (Intraocular Lens) | Device | Light-Adjustable Lens |
Primary outcome
Binocular Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months postop
7 secondary outcomes
Binocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months postop
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 3 months postop
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 3 months postop
Monocular Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months postop
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months postop
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 3 months postop
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 3 months postop
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- 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.
Clayton G Blehm, MD principal investigator
Gainesville Eye Associates
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 Gainesville Eye Associates 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 4 inclusion and 6 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 28 Jan 2026. 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 28 Jan 2026). 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?
Binocular Corrected Distance Visual Acuity (CDVA) (time frame: 3 months postop). 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 28 Jan 2026.