New cataract lens shows promise in early trial
NCT ID NCT05574959
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cataracts are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
- Which lens implant delivers sharper sight after cataract surgery?
- Eye surgery showdown: which technique spares more corneal cells?
- Eye gel showdown: new cataract surgery gel matches old standard
- New lens offers sharper sight at all distances for cataract patients
- New lens for cataracts: how happy are patients after surgery?