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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:
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.
The participants will be asked to use eye drops that have been prescribed by the doctor performing the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptilens A-IOL Cohort | Experimental | Comprised of all eyes implanted with the Adaptilens A-IOL. |
|
| Control Cohort | Active Comparator | Comprised of all eyes implanted with the CLAREON IOL CNA0T0 Monofocal IOL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accomodating Intra Ocular Lens | Device | This lens is accommodating. |
| |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of corrected distance visual acuity (CDVA) throughout the study. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liane Clamen, MD | Contact | 617-680-6888 | lianeclamen@adaptilens.com |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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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.
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| Monofocal Intra Ocular Lens |
| Device |
Monofocal lens |
|
| 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. | Enrollment through the end of the trial at 36 months. |