Evaluation of a new intraocular lens for cataract surgery
Randomized Controlled Study of Fluid Accommodating IOL Outcomes Versus Monofocal Control
This study is testing a new type of lens for cataract surgery to see if it can improve vision better than a standard lens for people getting the surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Alcon Research Industry-sponsored |
| Locations | 6 sites (San José and 5 other locations) |
| Trial ID | NCT05317728 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to assess the surgical, refractive, and visual outcomes of an investigational fluid accommodating intraocular lens (IOL) during cataract surgery. Eligible participants will undergo surgery to implant the IOL in both eyes, with the second eye procedure occurring 7 to 15 days after the first. The study includes two cohorts: one receiving either the test IOL or a control monofocal IOL, and the other receiving only the test IOL. Participants will be monitored for one year post-implantation to evaluate the effectiveness of the lens.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with bilateral cataracts requiring surgical intervention.
Not a fit: Patients with significant eye abnormalities or those who have had previous eye surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved visual outcomes for patients undergoing cataract surgery.
How similar studies have performed: Previous studies on intraocular lenses have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Able to understand and sign an Institutional Review Board / International Ethics Committee approved informed Consent form; * Willing and able to attend all scheduled study visits as required by the protocol; * Diagnosed with bilateral cataracts requiring removal by phacoemulsification with a clear corneal incision; * Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: * Subjects taking medications that may affect accommodation; * Clinically significant eye abnormalities as specified in the protocol; * Previous eye surgery as specified in the protocol; * Other protocol-specified exclusion criteria may apply.
Where this trial is running
San José and 5 other locations
- Clinica 20/20 — San José, Costa Rica (Active_not_recruiting)
- Laser Center SA — Santo Domingo, Dominican Republic (Completed)
- Centro de Retina Medica y Quirurgica SC — Zapopan, Jalisco, Mexico (Active_not_recruiting)
- Asociación Para Evitar la Ceguera en México — Mexico City, Mexico (Active_not_recruiting)
- Salauno Salud SAPI de CV — Mexico City, Mexico (Active_not_recruiting)
- Panama Eye Center — Panama, Panama (Recruiting)
Study contacts
- Study coordinator: Alcon Call Center
- Email: alcon.medinfo@alcon.com
- Phone: 1-888-451-3937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.