Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
435 participants
OBSERVATIONAL
2023-09-08
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-approval Follow-up Study of the IC-8 Apthera Intraocular Lens (IOL)
NCT05758883
IOL Implantation After KAMRA Inlay Removal
NCT03320473
Evaluation of the Safety & Effectiveness of the Bausch & Lomb AKREOS® TL Intraocular Lens
NCT00838045
Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal
NCT05776095
Prospective Clinical Trial to Evaluate the Safety and Effectiveness of the IOL
NCT03451786
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IC-8 Apthera intraocular lens (IOL) Group
Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
* Able to comprehend and have signed a statement of informed consent;
* Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
* Clear intraocular media in both eyes;
* Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
* Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.
Exclusion Criteria
* Irregular astigmatism in either eye;
* History of retinal disease;
* Active or recurrent anterior segment pathology;
* Presence of ocular abnormalities;
* Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
* Previous corneal or intraocular surgery, except cataract surgery;
* History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
* Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
* Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
* Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
* Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits
22 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Trinity Research Group, LLC
Dothan, Alabama, United States
Feinerman Vision Center
Newport Beach, California, United States
Argus Research Center
Cape Coral, Florida, United States
Stephenson Eye Associates
Venice, Florida, United States
Virdi Eye Clinic and Laser Vision Center
Rock Island, Illinois, United States
Price Vision Group
Indianapolis, Indiana, United States
Grene Vision Group
Wichita, Kansas, United States
Oakland Eye
Birmingham, Michigan, United States
Vance Thompson Vision - Omaha
Omaha, Nebraska, United States
Eye Associates of New Jersey
Dover, New Jersey, United States
Northern New Jersey Eye Institute
South Orange, New Jersey, United States
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, United States
Berkeley Eye Center
Sugar Land, Texas, United States
Utah Eye Centers
Bountiful, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
OD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAIL-101-PAS2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.