Extended Depth of Focus (EDF) Intraocular Lens (IOL) Versus Monofocal Intracoular Lens (IOL)

Официальное название

A Prospective, Randomized, Controlled, Observer-masked, Multi-center Clinical Trial to Demonstrate the Safety and Effectiveness of the Extended Depth of Focus AT LARA 829MP Posterior Chamber Intraocular Lens for Correction of Aphakia

Обзор

Extended depth of focus (EDF) intraocular lens (IOL) versus Monofocal intraocular lens (IOL)

Подробное описание

Extended depth of Focus intraocular lens versus a monofocal intraocular lens

Вмешательства

• Устройство EDF
  Extended depth of focus
• Устройство Monofocal IOL
  Monofocal

Первичные конечные точки

• Mean monocular Distance-Corrected Intermediate Visual Acuity (DCIVA) at 66 cm [Срок оценки: 6 Months]
• Mean monocular Corrected Distance Visual Acuity (CDVA) at 4 m [Срок оценки: 6 Months]
• Mean monocular Distance Corrected Visual Acuity (DCVA) at 1 m (equal to -1 D defocus) [Срок оценки: 6 Months]
• Mean monocular negative defocus range at the 0.20 logMAR compared to control [Срок оценки: 6 Months]
• Proportion of eyes achieving monocular photopic Distance Corrected Visual Acuity (CDVA) 0.30 logMAR or better [Срок оценки: 6 Months]

Вторичные конечные точки (1)

• Patient Reported Outcome (PRO) [Срок оценки: 6 Months]

Критерии участия

Критерии включения

• Patients of any gender, aged 18 years or older
• Patient with clinically significant bilateral age-related cataracts planned for phacoemulsification cataract extraction and eligible for implantation of a posterior chamber intraocular lens as determined by investigator's medical judgement
• Preoperative keratometric (corneal) astigmatism of 1.00 D or less (≤1.00 D)
• Calculated lens power within the available range
• Clear intraocular media other than cataract
• Patient is willing and capable of providing informed consent
• Patient is willing and capable of complying with visits and procedures as defined by this protocol

Критерии исключения

• Preoperative corrected distance visual acuity (CDVA) better than 0.3 logMAR (0.5 decimal)
• Endothelial cell count of less than 2000/mm2
• Acute, chronic, or uncontrolled systemic disease that could increase the operative risk or confound the outcome including but not limited to poorly controlled diabetes mellitus, active cancer treatment, mental illness, dementia, immunocompromised, connective tissue disease, clinically significant atopic disease, etc.
• Ocular condition that may predispose patient to future complications, per investigator's medical judgement, including but not limited to severe dry eye, anterior segment pathology, uncontrolled glaucoma, that would result in a visual acuity of 0.2 logMAR or worse during the study
• Clinically significant corneal abnormalities, including corneal dystrophy (epithelial, stromal or endothelial dystrophy), irregularity or oedema as per Investigator's medical judgement; conditions including but not limited to kerato-uveitis, keratopathy, keratectasia
• Previous intraocular or corneal/refractive surgery that might confound the outcome of the investigation or increase the risk to the patient (including corneal transplants, removal of pterygium, and LASIK, LASEK, PRK, RK limbal relaxing incision etc.)
• Any clinically significant condition that could affect IOL stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.)
• Patients with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders, optic nerve atrophy etc.) or any other pathologies of the eye that are predicted to result in a visual acuity of 0.2 logMAR or worse during the study
• Current systemic or ocular pharmacotherapy that effects patients' vision with significant ocular side effects or any medications that could confound the outcome or increase subject risk
• Clinically significant gonioscopic abnormalities
• Amblyopia, strabismus, single eye status
• Rubella, congenital, traumatic or complicated cataracts
• History of or current anterior or posterior segment inflammation, including but not limited to iritis or uveitis
• Microphthalmos or macrophthalmos
• Pupil abnormalities (e.g. aniridia, abnormal shaped pupils, nonreactive pupils)
• Pseudoexfoliation
• Keratoconus or irregular astigmatism
• Inability to measure keratometry or biometry (including but not limited to cataract density, etc.)
• Pathologic miosis
• Pregnant, plan to become pregnant, lactating during the course of the investigation, or another condition with associated fluctuation of hormones that could lead to refractive changes
• Patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial
• Patients whose freedom is impaired by administrative or legal order
• Concurrent participation in another clinical investigation in the last 30 days.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 5 центров

• Oftalvist — Alicante
• Hospital Universitario Ramón y Cajal — Madrid
• OMIQ Hospital Universitari — Sant Cugat del Vallès
• University Hopital Complex of Santiago de Compostela — Santiago de Compostela
• Oftalvist — Valencia

Болгария · 3 центра

• Eye Hospital Zora — Sofia
• Specialized Ophthalmological Hospital for Active Treatment — Sofia
• Medical Center "Vereya" — Stara Zagora

Чехия · 3 центра

• Nemocnice Havlíčkův — Havlíčkův Brod
• OFTEX ocni — Pardubice
• Oční Centrum — Prague

Румыния · 3 центра

• Oculus Eye Clinic — Bucharest
• Ofta Total Clinic — Sibiu
• Medoptic Clinic — Suceava

Идентификаторы

NCT: NCT07092020 · AT LARA 829MP BER-401-24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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