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New cataract lens shows promise in early trial

NCT ID NCT05574959

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study tested a new type of artificial lens (TECNIS DEN00V) for people having cataract surgery. It compared the new lens to a standard lens in 243 adults with cataracts. The goal was to see if the new lens improves vision at arm's length (66 cm) while keeping good distance vision. The trial was stopped early, so final conclusions are limited.

What this could mean

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

Active substance
intraocular lens (IOL) device
What this could lead to
If successful, this lens could provide better intermediate vision after cataract surgery while maintaining good distance vision.
What could go wrong
The trial was terminated early, so results are limited. It was a device study, not a drug, so benefits are incremental rather than transformative.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

243 people

The number who actually took part.

Started

Oct 2022

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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. Minimum 22 years of age; 2. Bilateral cataracts for which posterior chamber IOL implantation has been planned; 3. Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source; 4. Potential for postoperative BCDVA of 20/30 Snellen or better; 5. Corneal astigmatism: 1. Normal corneal topography; 2. ≤ 1.0 D of preoperative keratometric astigmatism; 6. Clear intraocular media other than cataract; 7. Availability, ability, willingness and sufficient cognitive awareness to comply with examination procedures; 8. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries; 9. Ability to understand and respond to a questionnaire in English. Exclusion Criteria: 1. Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D; 2. Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils); 3. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.); 4. Prior corneal refractive surgery (SMILE, LASIK, LASEK, RK, PRK, etc.); 5. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study; 6. Irregular corneal astigmatism; 7. Inability to achieve keratometric stability for contact lens wearers (as defined in preoperative procedures); 8. History of intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs; 9. Recent ocular trauma that is not resolved/stable or may affect visual outcomes or increase risk to the subject; 10. Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study; 11. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects; 12. Use of systemic or ocular medications that may affect vision; 13. Prior, current, or anticipated use during the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the investigator, confound the outcomes or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery); 14. Poorly controlled diabetes; 15. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcomes of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable; 16. Known ocular disease or pathology that, in the opinion of the investigator: 1. may affect visual acuity; 2. may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.); 3. may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.); 17. Pregnancy, planned pregnancy, presently lactating or another condition associated with hormonal fluctuation that could lead to refractive changes; 18. Concurrent participation or participation within 30 days prior to preoperative visit in any other clinical trial; 19. Desire for monovision correction.

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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.

Contacts and locations

Locations

  • Carolina EyeCare Physicians, LLC

    Mt. Pleasant, South Carolina, 29464, United States

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242, United States

  • Empire Eye & Laser Center

    Bakersfield, California, 93309, United States

  • Focal Point Vision

    San Antonio, Texas, 78209, United States

  • Jones Eye Center

    Sioux City, Iowa, 51104, United States

  • OCLI Vision

    Garden City, New York, 11530, United States

  • Parkhurst NuVision

    San Antonio, Texas, 78229, United States

  • Southern California Eye Physicians and Associates

    Long Beach, California, 90805, United States

  • Whitsett Vision Group

    Houston, Texas, 77055, United States

  • Wolstan & Goldberg Eye Associates

    Torrance, California, 90505, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.