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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
AAL-FAIOL
DeviceIntraocular 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.
BAL-FAIOL
DeviceIntraocular 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.
Phacoemulsification
Procedure/SurgeryCataract surgery technique that uses ultrasound to break up and remove the clouded lens, allowing for intraocular lens (IOL) implantation.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: AAL-FAIOLExperimental treatment 2 interventions
Group B: BAL-FAIOLExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cumulative ocular adverse events (AEs), including Secondary Surgical Interventions (SSIs)
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.
Time frame
From Day 0 up to Month 12Sponsors and contacts
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Source ClinicalTrials.gov