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 goals of this feasibility study are to learn more about the performance of the intraocular lens (IOL), if the IOL is safe for use, and what the best surgical techniques are for implanting the IOL in patients who require correction of aphakia following phacoemulsification extraction of a senile cataract.
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.
* 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.
* 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.
Exclusion Criteria:
* Planned secondary procedures (such as LASIK) during the term of the study; Nd YAG capsulotomy is permitted.
* Taking systemic medications that may confound the outcome or increase the risk to the subject.
* Ocular conditions that may predispose for future complications.
* Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject.
* Pregnant, lactating during the course of the investigation, or with another condit…
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.