CataractPhase 4NCT07693205
A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects
A Phase 4 study testing Clareon TruPlus and Clareon monofocal in people with Cataract, run by Berkeley Eye Center at 1 site in United States.
Trial summary
This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Clareon TruPlus and Clareon monofocal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2026to Jul 2027
- Phase
- Phase 4
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
- Ability to understand and sign an IRB/ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism <0.50 D.
- IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
- Ability to understand and complete study questionnaires.
Who cannot join
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
- Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
- Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
- History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
- Prior ocular surgery (including corneal refractive surgery) in either eye.
- Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
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- Participation in another clinical study (interventional) that could interfere with study results.
- Planned monovision/mini-monovision or desire for monovision targeting.
- Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
- Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
- Any active ocular infection or inflammation.
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
Berkeley Eye Center - Sugar Land
Sugar Land, Texas, 77478
Tetiana Clinical Research Coordinator, 713-526-1600, tetiana.huff@berkeleyeye.com
About this study
This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.
- Conditions
- Cataract
- Being tested
- Clareon TruPlus, Clareon monofocal
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clareon TruPlusDevice
Bilateral implantation with Clareon TruPlus
Clareon monofocalDevice
Bilateral implantation with Clareon monofocal
| Study group | Role | What they receive |
|---|---|---|
| Clareon TruPlus | Experimental | Not described Receives: Device: Clareon TruPlus |
| Clareon monofocal | Active comparator | Not described Receives: Device: Clareon monofocal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular photopic corrected distance visual acuity (CDVA) at 4 m
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start12 Jun 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Berkeley Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693205
- Sponsor's protocol ID
- 102811821
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 21 Jul 2026
- 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 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects
- ClinicalTrials.gov ID
- NCT07693205
- Acronym / sponsor ID
- 102811821
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Berkeley Eye CenterUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 12 Jun 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 9 Jul 2026 (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 investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clareon TruPlus | Experimental | Device: Clareon TruPlus |
| Clareon monofocal | Active comparator | Device: Clareon monofocal |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
- Ability to understand and sign an IRB/ethics committee-approved informed consent form.
- Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
- Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
- Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism <0.50 D.
Key exclusion criteria (11 listed)
- Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
- Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
- Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
- History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
- Prior ocular surgery (including corneal refractive surgery) in either eye.
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 TruPlusBilateral implantation with Clareon TruPlus | Device | Clareon TruPlus |
| Clareon monofocalBilateral implantation with Clareon monofocal | Device | Clareon monofocal |
Primary outcome
Binocular photopic corrected distance visual acuity (CDVA) at 4 m
Time frame: 3 months postoperatively
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 21 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clareon TruPlus and Clareon monofocal in people with Cataract, run by Berkeley Eye 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 7 inclusion and 11 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 21 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tetiana Huff (713-620-7640, tetiana.huff@berkeleyeye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular photopic corrected distance visual acuity (CDVA) at 4 m (time frame: 3 months postoperatively). 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 21 Jul 2026.