Clinical Evaluation of the Adaptilens Accommodating IOL

NCT07607860 | Not Yet Recruiting FDA Device

• 1 other identifier: ADP-FIH-001
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Aphakia Cataract

Keywords

Intraocular lens; Accomodating Intraocular Lens; A-IOL; IOL; cataract

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Enrollment through end of the study at 36 months.

Secondary Outcomes (2)

• Change of corrected distance visual acuity (CDVA) throughout the study.

  Enrollment through 12 months.

• Change in uncorrected near visual acuity (UNVA) throughout the study.

  Enrollment through the end of the trial at 36 months.

Study Arms (2)

Adaptilens A-IOL Cohort

EXPERIMENTAL

Comprised of all eyes implanted with the Adaptilens A-IOL.

Device: Accomodating Intra Ocular Lens

Control Cohort

ACTIVE COMPARATOR

Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL

Device: Monofocal Intra Ocular Lens

Interventions

Accomodating Intra Ocular Lens DEVICE

This lens is accommodating.

Adaptilens A-IOL Cohort

Monofocal Intra Ocular Lens DEVICE

Monofocal lens

Control Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adaptilens, Inc.: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Liane Clamen, MD

CONTACT

617-680-6888; lianeclamen@adaptilens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are two treatment cohorts, and three sequential stages of enrollment. Adaptilens A-IOL Cohort: Comprised of all eyes implanted with the Adaptilens A-IOL. Control Cohort: Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 28, 2026

Record last verified: 2026-05