Aphakia Cataract
Conditions
Keywords
Intraocular lens, Accomodating Intraocular Lens, A-IOL, IOL, cataract
Brief 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.
Interventions
DEVICEAccomodating Intra Ocular Lens
This lens is accommodating.
DEVICEMonofocal Intra Ocular Lens
Monofocal lens
Sponsors
Adaptilens, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * 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.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | Enrollment through end of the study at 36 months. | Effectiveness parameter to be evaluated is improvement in corrected distance visual acuity (CDVA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in uncorrected near visual acuity (UNVA) throughout the study. | 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. |
Contacts
CONTACTLiane Clamen, MD
Outcome results
None listed