Accommodating intraocular lens design for cataract patients
Feasibility Study of an Accommodating IOL Design
NA · Alcon Research · NCT07147192
This trial will test whether a new accommodating intraocular lens (AAL-FAIOL) is safe and helps people needing cataract surgery see better compared with a standard lens (BAL-FAIOL).
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Alcon Research (industry) |
| Locations | 5 sites (Fort Worth, Texas and 4 other locations) |
| Trial ID | NCT07147192 on ClinicalTrials.gov |
What this trial studies
Adults with cataracts in both eyes will undergo phacoemulsification, with one eye receiving the experimental AAL-FAIOL and the other eye receiving the BAL-FAIOL, with surgeries spaced 14–35 days apart. Participants will be followed for about one year with scheduled visits to monitor safety, vision, and lens performance. If needed, the AAL lens may be adjusted after surgery with a laser to try to improve vision. The study is being conducted at participating sites in Central America under sponsorship of Alcon Research.
Who should consider this trial
Good fit: Ideal candidates are adults with bilateral cataracts who can consent and attend all study visits and who have preoperative corneal astigmatism ≤1.50 diopters in both eyes.
Not a fit: Patients with glaucoma or ocular hypertension, significant corneal astigmatism (>1.50 D), those taking medications that affect accommodation, pregnant or breastfeeding women, or those with medical conditions that increase surgical risk may not benefit from this approach.
Why it matters
Potential benefit: If successful, the accommodating lens could improve near and distance vision after cataract surgery and reduce reliance on glasses.
How similar studies have performed: Other accommodating IOL designs have been tested previously with mixed results—some showed modest improvements in near vision but overall outcomes have been variable.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Able to understand and sign an Informed Consent Form. * Willing and able to attend all scheduled study visits required per protocol. * Diagnosed with bilateral cataracts requiring removal by phacoemulsification. * Preoperative corneal astigmatism equal to or less than 1.50 diopter (D) in both eyes. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Women of childbearing potential who are pregnant, intend to become pregnant during the study, or are breastfeeding. * Taking medications that could increase risk or may affect accommodation. * Eye conditions as specified in the protocol, including glaucoma or ocular hypertension. * Medical conditions that could increase operative risk as specified in the protocol. * Other protocol-defined exclusion criteria may apply.
Where this trial is running
Fort Worth, Texas and 4 other locations
- Contact Alcon Call Center for Trial Locations — Fort Worth, Texas, United States (NOT_YET_RECRUITING)
- Clinica 20/20 — San José, Costa Rica (RECRUITING)
- Instituto Espaillat Cabral — Santo Domingo, Dominican Republic (NOT_YET_RECRUITING)
- Centro Panamericano de Ojos / Clinica Lopez Beltran — San Salvador, El Salvador (NOT_YET_RECRUITING)
- Panama Eye Center — Panama City, 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.