Aphakia CataractNCT07607860
Clinical Evaluation of the Adaptilens Accommodating IOL
A study testing Accomodating Intra Ocular Lens and Monofocal Intra Ocular Lens in people with Aphakia Cataract, run by Adaptilens, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Aphakia Cataract
- What is being tested?
- Accomodating Intra Ocular Lens and Monofocal Intra Ocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility Clinical Evaluation of the Adaptilens Accommodating IOL
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.
- Conditions
- Aphakia Cataract
- Being tested
- Accomodating Intra Ocular Lens, Monofocal Intra Ocular Lens
- Keywords
- Intraocular lens, Accomodating Intraocular Lens, A-IOL, IOL, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accomodating Intra Ocular LensDevice
This lens is accommodating.
Monofocal Intra Ocular LensDevice
Monofocal lens
| Study group | Role | What they receive |
|---|---|---|
| Adaptilens A-IOL Cohort | Experimental | Comprised of all eyes implanted with the Adaptilens A-IOL. Receives: Device: Accomodating Intra Ocular Lens |
| Control Cohort | Active comparator | Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL Receives: Device: Monofocal Intra Ocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Enrollment through end of the study at 36 months.
Secondary outcomes (1)
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.
Measured: Enrollment through the end of the trial at 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aphakia CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- There are two treatment cohorts. Adaptilens A-IOL Cohort: Comprised of all eyes implanted with the Adaptilens A-IOL. Control Cohort: Comprised of all eyes implanted with a monofocal IOL.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adaptilens, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607860
- Sponsor's protocol ID
- ADP-FIH-001
- Status last verified
- Aug 2026
- First submitted
- 19 May 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Clinical Evaluation of the Adaptilens Accommodating IOL
- ClinicalTrials.gov ID
- NCT07607860
- Acronym / sponsor ID
- ADP-FIH-001
- Conditions
- Aphakia Cataract
- Keywords
- Intraocular lens, Accomodating Intraocular Lens, A-IOL, IOL, cataract
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Adaptilens, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two treatment cohorts. Adaptilens A-IOL Cohort: Comprised of all eyes implanted with the Adaptilens A-IOL. Control Cohort: Comprised of all eyes implanted with a monofocal IOL.
| Arm | Type | Receives |
|---|---|---|
| Adaptilens A-IOL Cohort | Experimental | Device: Accomodating Intra Ocular LensComprised of all eyes implanted with the Adaptilens A-IOL. |
| Control Cohort | Active comparator | Device: Monofocal Intra Ocular LensComprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accomodating Intra Ocular LensThis lens is accommodating. | Device | Adaptilens A-IOL Cohort |
| Monofocal Intra Ocular LensMonofocal lens | Device | Control Cohort |
Primary outcome
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.
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).
1 secondary outcome
Change in uncorrected near visual acuity (UNVA) throughout the study.
Time frame: Enrollment through the end of the trial at 36 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Accomodating Intra Ocular Lens and Monofocal Intra Ocular Lens in people with Aphakia Cataract, run by Adaptilens, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liane Clamen, MD (617-680-6888, lianeclamen@adaptilens.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.