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Not yet recruiting NCT07607860

Clinical Evaluation of the Adaptilens Accommodating IOL

No phase Interventional Aphakia Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accomodating Intra Ocular Lens, Monofocal Intra Ocular Lens.
Who it may be relevant to
Registry conditions: Aphakia Cataract. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Feasibility Clinical Evaluation of the Adaptilens Accommodating IOL

Overview

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

  • Device Accomodating Intra Ocular Lens
    This lens is accommodating.
  • Device Monofocal Intra Ocular Lens
    Monofocal lens

Primary outcome measures

  • 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.]
  • Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study. [Time frame: Enrollment through end of the study at 36 months.]
Secondary outcome measures (1)
  • Change in uncorrected near visual acuity (UNVA) throughout the study. [Time frame: Enrollment through the end of the trial at 36 months.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07607860 · ADP-FIH-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗