Aphakia
Conditions
Keywords
Cataract
Brief summary
The purpose of this clinical study is to assess safety and explore usability and effectiveness of the test product, AAL-FAIOL. This study will be conducted in Central America.
Detailed description
This study will enroll adult subjects who require cataract surgery in both eyes. One eye will receive the AAL-FAIOL and the other eye will receive the BAL-FAIOL. The two eye surgeries will be separated by 14-35 days. Subjects will attend follow up visits for approximately 1 year. If needed, the AAL lens may be adjusted after surgery with a laser to help give the participant better vision.
Interventions
DEVICEAAL-FAIOL
Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject. Laser energy to specified locations can be used to allow a change in power for far distances.
DEVICEBAL-FAIOL
Intraocular lens (IOL) placed into the lens capsule of the eye during cataract surgery. IOLs are implantable medical devices intended for long-term use over the lifetime of the pseudophakic subject.
PROCEDUREPhacoemulsification
Cataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Contralateral implantation
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs) | From Day 0 up to Month 12 | The number of adverse events, including SSI's, will be calculated. An SSI is a subsequent operation performed to address issues or complications arising from a previous surgical procedure. AEs will be collected starting at Day 0 after informed consent. SSIs will be collected starting Day 1. |
Countries
Costa Rica, Dominican Republic, El Salvador, Panama
Contacts
STUDY_DIRECTORClinical Trial Lead, Surgical
Alcon Research, LLC
Outcome results
None listed