Actively Recruiting
Feasibility Study of an Accommodating Intraocular Lens Design for Cataract Surgery
Led by Alcon Research · Updated on 2026-05-19
85
Participants Needed
4
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and usability of a new intraocular lens (IOL) called AAL-FAIOL for adults who need cataract surgery in both eyes. The study is conducted in Central America and aims to compare the AAL-FAIOL lens with another lens called BAL-FAIOL. The goal is to explore how well these lenses work and how safe they are for long-term use after cataract removal. Participants will have cataract surgery in both eyes, with one eye receiving the AAL-FAIOL lens and the other eye receiving the BAL-FAIOL lens. The surgeries in the two eyes will be scheduled 14 to 35 days apart. The AAL-FAIOL lens can be adjusted after surgery using laser treatment if needed to improve vision. Both lenses are implanted during cataract surgery using a technique called phacoemulsification. During the study, participants will attend follow-up visits for about one year to monitor their eye health and vision. Researchers will check for any eye-related adverse events or complications, including any additional surgeries needed. The study will measure the overall safety of the lenses and how well participants do over this 12-month period after their surgeries.
CONDITIONS
Brief Title
Feasibility Study of an Accommodating IOL Design
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 in both eyes
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Women who are pregnant, plan to become pregnant during the study, or are breastfeeding
- Taking medications that could increase risk or affect accommodation
- Eye conditions such as glaucoma or ocular hypertension as specified in the protocol
- Medical conditions that increase operative risk as specified in the protocol
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 to 35 days
Participants undergo cataract surgery on one eye to receive the AAL-FAIOL device, followed by surgery on the other eye to receive the BAL-FAIOL device. The two eye surgeries are separated by 14 to 35 days.
2 surgery visits (in-person)
Duration - Approximately 1 year
Participants attend follow-up visits for approximately 1 year to monitor recovery and outcomes. If needed, the AAL lens may be adjusted after surgery with a laser to improve vision.
Multiple follow-up visits over 1 year
Trial Site Locations
Total: 4 locations
1
Clinica 20/20
San José, Costa Rica
Actively Recruiting
2
Instituto Espaillat Cabral
Santo Domingo, Dominican Republic
Not Yet Recruiting
3
Centro Panamericano de Ojos / Clinica Lopez Beltran
San Salvador, El Salvador
Not Yet Recruiting
4
Panama Eye Center
Panama City, Panama
Actively Recruiting
Research Team
A
Alcon Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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