Feasibility Study of an Accommodating IOL Design
ConditionAphakia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorAlcon Research
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AAL-FAIOL
- BAL-FAIOL
- Phacoemulsification
Treatment groups
85 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov