New lens design aims to sharpen vision after cataract surgery

NCT ID NCT07693205

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study compares two types of artificial lens implants used during cataract surgery: the Clareon TruPlus and a standard monofocal lens. About 180 adults with cataracts in both eyes will receive one type of lens in each eye. The goal is to see if the TruPlus lens improves distance vision more than the standard lens. Participants and the staff measuring their vision will not know which lens was implanted, but the surgeon will know.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clareon TruPlus intraocular lens
What this could lead to
If successful, this could show that the Clareon TruPlus lens provides better distance vision than standard monofocal lenses after cataract surgery.
What could go wrong
This is a relatively small, early-phase study, and results may not apply to all patients. There is always a risk of complications from surgery or that the new lens offers no significant advantage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts. 2. Ability to understand and sign an IRB/ethics committee-approved informed consent form. 3. Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures. 4. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator. 5. 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. 6. IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family. 7. Ability to understand and complete study questionnaires. Exclusion Criteria: 1. Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation). 2. 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. 3. Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes. 4. History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing. 5. Prior ocular surgery (including corneal refractive surgery) in either eye. 6. Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing. 7. Participation in another clinical study (interventional) that could interfere with study results. 8. Planned monovision/mini-monovision or desire for monovision targeting. 9. Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment. 10. Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments. 11. Any active ocular infection or inflammation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Berkeley Eye Center - Sugar Land

    RECRUITING

    Sugar Land, Texas, 77478, United States

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