Clinical Evaluation of the Adaptilens Accommodating IOL

May 26, 2026 updated by: Adaptilens, Inc.

Feasibility Clinical Evaluation of the Adaptilens Accommodating IOL

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.
  • 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 condition associated with fluctuation of hormones that could lead to refractive changes.
  • Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future CDVA loss worse than 20/40.
  • Any anterior segment pathology (anterior segment or corneal abnormalities, chronic uveitis, iritis, corneal dystrophy, pseudoexfoliation, etc.).
  • Glaucoma, glaucoma suspect or ocular hypertension, i.e., IOP > 22 mmHg.
  • Previous retinal detachment or retinal pathology, including age-related macular degeneration.
  • Diabetes, currently being treated systemically and with retinopathy.
  • Systemic or ocular disease that may prevent the patient from achieving CDVA of 20/32 or better post operatively.
  • Require chronic administration of any topical ophthalmic or systemic medication that may affect accommodation such as mydriatic, cycloplegic and myotic agents; tricyclic antidepressants, phenothiazines, benzodiazepines, first generation antihistamines, anticholinergic agents.
  • CDVA of 20/32 or worse in the fellow eye not attributable to cataract.
  • Current participation in, or have participated in, an investigational study, other than this study, within the previous 60 days before the operative day.
  • Previous ocular surgery in the operative eye, including refractive surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adaptilens A-IOL Cohort
Comprised of all eyes implanted with the Adaptilens A-IOL.
Device: Accomodating Intra Ocular Lens
This lens is accommodating.
Active Comparator: Control Cohort
Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL
Device: Monofocal Intra Ocular Lens
Monofocal lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: From enrollment to the end of the study at 36 months.
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.
From enrollment to the end of the study at 36 months.
Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study.
Time Frame: Enrollment through end of the study at 36 months.
Effectiveness parameter to be evaluated is improvement in corrected distance visual acuity (CDVA).
Enrollment through end of the study at 36 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in uncorrected near visual acuity (UNVA) throughout the study.
Time Frame: Enrollment through the end of the trial at 36 months.
Improvement in uncorrected near visual acuity (UNVA) will be evaluated as a secondary measure of visual performance.
Enrollment through the end of the trial at 36 months.
Change of corrected distance visual acuity (CDVA) throughout the study.
Time Frame: Enrollment through 12 months.

Less than 5% of eyes should lose more than 2 lines of CDVA at 12 months postoperatively that is device related.

Less than 5% of subjects should have CDVA of worse than 20/40 at 12 months postoperatively that is device related, if the preoperative CDVA was 20/40 or better.
Enrollment through 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adaptilens, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 22, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADP-FIH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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