Clinical Evaluation of the Adaptilens Accommodating IOL (NCT07607860) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Evaluation of the Adaptilens Accommodating IOL
100 participantsStarted 2026-09
Plain-language summary
The goal of this feasibility study is to learn more about the performance of the intraocular lens device, if the device is safe for use and what the best surgical techniques are for implanting the product in patients who require correction of aphakia following phacoemulsification extraction of a senile cataract. The main questions it aims to answer are:
* Will the patient have any related complications?
* Will a patient's vision improve after surgery?
Researchers will compare the eye treated with the investigational product with the eye treated with another product to see if there are any differences in vision and safety.
* Participants will be asked to attend all scheduled visits for the study, approximately 11 visits in total over 3 years.
* During these visits the participants will be asked about their medical history, have testing and measurements taken, and one visit that is the scheduled surgery.
The participants will be asked to use eye drops that have been prescribed by the doctor performing the surgery.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults who are at least 21 years of age or older and of legal age or capacity to consent.
* Scheduled to undergo primary intraocular lens implantation for the correction of aphakia following phacoemulsification extraction of a senile cataract.
* Clear intraocular media other than cataract.
* Potential visual acuity of 20/32 or better in both eyes after cataract removal and IOL implantation as determined by diagnostic testing or investigator's judgement.
* Preoperative corrected distance visual acuity (CDVA) worse than 20/40 either with or without a glare source present (e.g., Brightness Acuity Tester) or scheduled for cataract removal due to significant cataract-related symptoms/complaints.
* Calculated IOL power is within the range of the investigational IOL (+17.0 to +24.0 D).
* Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism.
* In good general health at screening as determined by the investigator.
* Signed written informed consent.
* Availability, willingness, and sufficient cognitive awareness to comply with examination procedures and schedule.
* Operative Criteria -- For unilaterally implanted Adaptilens A-IOL Eyes: Completion of uncomplicated cataract surgery with implantation of the Control IOL and with no ongoing or persistent sight-threatening adverse events in the Control eye.
Exclusion Criteria:
* Planned secondary procedures (such as LASIK) during the term of the study; Nd YAG capsulotomy is permitted.
* Taki…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rates of cumulative and persistent surgical related complications observed in the Adaptilens A-IOL implanted eyes, compared to threshold rates when adjusted for the type of pre-existing condition for which the subjects are being treated.
Timeframe: From enrollment to the end of the study at 36 months.
2
Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study.
Timeframe: Enrollment through end of the study at 36 months.