Clinical Evaluation of the Adaptilens Accommodating IOL

Официальное название

Feasibility Clinical Evaluation of the Adaptilens Accommodating IOL

Обзор

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.

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: From enrollment to the end of the study at 36 months.]
• Effectiveness parameter corrected distance visual acuity (CDVA) throughout the course of the study. [Срок оценки: Enrollment through end of the study at 36 months.]

Вторичные конечные точки (1)

• Change in uncorrected near visual acuity (UNVA) throughout the study. [Срок оценки: Enrollment through the end of the trial at 36 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07607860 · ADP-FIH-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗