An interventional study of Accomodating Intra Ocular Lens and Monofocal Intra Ocular Lens in Aphakia Cataract, sponsored by Adaptilens, Inc.. Not yet recruiting. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Adaptilens, Inc. · Not applicable, Interventional, and Treatment
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.
1,629 studies on the registry are indexed under Cataract; 235 are open to participants now.
This study's planned enrollment of 100 is above the median of 79 across 1,092 interventional studies indexed under Cataract.
Browse Cataract studies →This is the only study on the registry with Adaptilens, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Comprised of all eyes implanted with the Adaptilens A-IOL.
Device: Accomodating Intra Ocular Lens
Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL
Device: Monofocal Intra Ocular Lens
This lens is accommodating.
Monofocal lens
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.
Cumulative rates of cystoid macular edema, hypopyon, endophthalmitis, lens dislocated from posterior chamber, pupillary block, retinal detachment, secondary surgical intervention. Persistent rates of cornela edema at 3 months postop or later, cystoid macular edema, iritis, IOP \>30 mm Hg requiring treatment.
Time frame: From enrollment to the end of the study at 36 months.
Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study.
Effectiveness parameter to be evaluated is improvement in corrected distance visual acuity (CDVA).
Time frame: Enrollment through end of the study at 36 months.
Change in uncorrected near visual acuity (UNVA) throughout the study.
Improvement in uncorrected near visual acuity (UNVA) will be evaluated as a secondary measure of visual performance.
Time frame: Enrollment through the end of the trial at 36 months.
No study locations are listed for this record.
Start is estimated for Sep 2026; primary completion for Dec 2030, 51 months later.
Of 190 industry-sponsored interventional studies with no phase under Cataract, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 51 months is above that.
Counting every sponsor, half of 490 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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