Clinical Evaluation of a Novel Trifocal IOL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LPYWT0, PXYWT0, Cataract Surgery.
- Who it may be relevant to
- Registry conditions: Aphakia, Cataract. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India, Philippines
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to understand the visual outcomes of the investigational intraocular lens (IOL) Model LPYWT0 when compared to the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0.
Detailed description
In this study, subjects with cataracts in both eyes will undergo cataract surgery and be implanted with trifocal IOLs. One eye will receive the investigational IOL Model LPYWT0 IOL, and the other eye will receive the commercially marketed Clareon PanOptix Pro IOL Model PXYWT0. The second eye surgery will occur 7-14 days after the first. Subjects will attend 9 planned study visits to include for an individual duration of participation of approximately 7 months.
This study is planned to be conducted in India and the Philippines.
Interventions
- Device LPYWT0
Investigational blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject. - Device PXYWT0
Commercially available blue light filtering trifocal IOL implanted in the capsular bag of the eye during cataract surgery intended to remain in the eye for the lifetime of the subject. - Procedure Cataract Surgery
Removal of the cataractous lens by phacoemulsification followed by implantation of the IOL
Primary outcome measures
- Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) [Time frame: Month 6 postoperative]
Eligibility criteria
Inclusion criteria
- The calculated power needed for the artificial lens (IOL) must be between +15.0 and +25.0 D in each eye, designed to bring subject vision as close to "0.0" (neutral) as possible, meaning they will not be strongly nearsighted or farsighted after surgery.
- Subjects must have low levels of astigmatism (misshapen cornea) in the eyes (less than 1.00 D).
- In the doctor's opinion, the subjects have the potential to achieve good vision (0.2 logMAR, which is roughly 20/32 Snellen or better) in each eye after the surgery, when wearing the best possible spectacles or contact lenses.
- Other protocol-specified inclusion criteria may apply.
Exclusion criteria
- Clinically significant corneal diseases which may, according to the investigator's medical opinion, adversely affect visual outcomes.
- Any ocular or systemic health condition or medical issue that, in the investigator's medical opinion, could make the study results unreliable, prevent the person from finishing the study, or increase their safety risk.
- People who want to have one eye set for distance vision and the other for near vision.
- The doctor expects significant blurry vision (astigmatism) after the procedure.
- Other protocol-specified exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
India · 2 centers
- Dr. Agarwal's Eye Hospital Limited — Chennai
- Narayana Nethralaya — Bangalore
Philippines · 2 centers
- Peregrine Eye Laser and Institute — Makati City
- Asian Eye Institute — Makati City
Identifiers
NCT: NCT07587138 · ILW559-C003