A new lens design aims to improve vision after cataract surgery
NCT ID NCT06428955
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial tests a new type of intraocular lens, the CT LUCIA 621P, designed to improve vision after cataract surgery. The lens has a special shape that may correct vision more precisely than standard lenses. Researchers will measure how well people see at distance and intermediate range three months after surgery. The study includes adults aged 50 and older having routine cataract surgery in both eyes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a hydrophobic aspheric monofocal intraocular lens with a non-constant aspheric optic profile, called CT LUCIA 621P
- What this could lead to
- If successful, this lens could provide sharper distance and intermediate vision after cataract surgery, potentially reducing the need for glasses.
- What could go wrong
- This is a small, early-phase study with only 44 participants, so results may not apply to everyone. Risks include typical surgical complications like infection or inflammation.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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44 people
The number who actually took part.
- Started
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Jun 2024
- Finished
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Feb 2026
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Be at least 50 years of age or older, male or female, of any race or ethnicity. 2. Presenting for uncomplicated bilateral cataract surgery for age-related cataract. 3. Planned bilateral cataract extraction with posterior chamber IOL implantation, via phacoemulsification with or without femtosecond laser assisted cataract surgery (FLACS). 4. Bilateral implantation of a CT LUCIA 621P IOL with a dioptric power between +10.00 D and +30.00 D and a target postoperative refraction of emmetropia (0.00 ±0.50 D). 5. Clear intraocular media other than cataract (i.e. no hyphema, vitreous hemorrhage) 6. No visual acuity limiting pathologies other than cataract. Best corrected postoperative visual acuity potential of 20/25 or better in both eyes as estimated by potential acuity meter or surgeon estimation. 7. Provide written informed consent and a signed HIPPA form. 8. Availability, willingness, ability, and sufficient cognitive awareness to comply with study examination procedures and the schedule for study visits and evaluations. Exclusion Criteria: 1. Corneal Astigmatism of \>1.0 D. 2. Planned monocular cataract extraction. 3. Visual field loss which has an impact on visual acuity. 4. Subjects with intraoperative surgical complications in whom a CT LUCIA 621P IOL cannot be implanted. 5. History of acute or chronic disease, pathology, illness, or ocular trauma that would, in the surgeon's opinion, confound results (e.g., corneal pathology, keratoconus, strabismus, uncontrolled glaucoma) 6. History of Glaucoma, macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, amblyopia, etc. 7. Previous intraocular or corneal surgery, including all forms of refractive surgery that might confound the outcome of the investigation or increase the risk to the subject 8. Previous anterior or posterior chamber surgery other than peripheral retinal barrier laser, SLT/ALT (e.g., vitrectomy, laser iridotomy) 9. Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions). 10. Capsular or zonular abnormalities or other conditions that increase the risk of zonular rupture during cataract extraction procedure and/or may affect the postoperative centration or tilt of the lens 11. Use of a systemic or ocular medication that might affect vision and confound the outcome or increase the risk to the subject in the opinion of the investigator such as tamsulosin hydrochloride (Flomax) or other medications with similar side effects (floppy iris syndrome) 12. Cycloplegic pupil diameter \<6.0 mm or the presence of ocular implants that limit pupil diameter (malyugin rings; iris prosthesis). 13. Usage of contact lenses during study participation 14. Pregnant, lactating during the course of the investigation, or has another condition with associated fluctuation of hormones that could lead to refractive changes 15. Presence or history or any other condition or finding that, in the investigator's opinion, makes the subject unsuitable as a candidate for study participation, may increase the operative risk or may confound the outcome of the study.
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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
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Huffman & Huffman PSC
Lexington, Kentucky, 40509, United States
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Price Vision Group
Indianapolis, Indiana, 46260, United States
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The Pennsylvania State University and Penn State Health
Hershey, Pennsylvania, 17033, United States
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