Visual Outcomes of Tecnis Symfony Opti-Blue EDOF Intraocular Lens (IOL)

Официальное название

Visual Outcomes Following Implantation of Tecnis Symfony Opti-Blue EDOF IOL in Patients With Mild to Moderate Retinal Ocular Comorbidities

Обзор

Tecnis Symfony Optiblue EDOF IOL is the latest version of Tecnis Symfony IOL with a violet light filter (VLF), which blocks short-wavelength light and improves the quality of vision while minimizing visual disturbances. The present study aims to assess the visual outcomes at distance, intermediate, and near following cataract surgery and implantation of Tecnis Symfony Optiblue IOL in patients with retinal comorbidities.

Подробное описание

Extended depth of focus (EDOF) IOLs, on the other hand, are based on the principle of creating a single-elongated focal point to enhance the depth of focus (DOF) and eliminate the overlapping of near and far images caused by traditional multifocal IOLs, thus generating a lower incidence of halos and glare. The Tecnis Symfony (Johnson \& Johnson Vision) EDOF IOL incorporates a diffractive echelette design to increase the range of vision. The achromatic technology corrects chromatic aberration and increases retinal image contrast.

The latest version of the Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts. As such, the present study aims to assess the visual outcomes at distance, intermediate and near following implantation of violet light filtering Tecnis Symfony Optiblue EDOF IOLs in patients with retinal comorbidities undergoing cataract surgery.

Вмешательства

• Устройство Tecnis Symfony OptiBlue/ Tecnis Symfony OptiBlue toric IOL
  Tecnis Symfony lens (DXR00V/ZXR00V) has the OptiBlue violet light filter (VLF), which blocks short-wavelength light. Violet light filtration reduces light scatter, improving contrast and reducing nighttime visual disturbances such as halo, glare, and starbursts.

Первичные конечные точки

• Binocular uncorrected visual acuity at distance [Срок оценки: 3 months]
• Binocular uncorrected visual acuity at intermediate [Срок оценки: 3 months]
• Binocular uncorrected visual acuity at near [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients diagnosed with retinal comorbidities, with visual acuity potential of 20/30 or better, who wish to undergo bilateral cataract surgery and are willing to provide written informed consent and adhere to study requirements.

Критерии исключения

• Corneal dystrophies
• Central corneal scarring
• Keratoconus
• Proliferative diabetic retinopathy
• Exudative macular degeneration
• Zonular weakness
• Pseudoexfoliation
• Fovea-involving atrophy
• Severe dry eye
• Amblyopia
• Pupil abnormalities
• Need for an IOL outside the range of +5.0 D to +34.0 D or cylinder power over 3.75 D
• Patients who have undergone prior cataract surgery and IOL implantation in either eye; had prior corneal refractive or corneal transplantation surgery; diabetics post-vitrectomy; or who have a history of macula-off retinal detachment will also be excluded.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Coastal eye surgeons — Greenwich

Идентификаторы

NCT: NCT06500416 · CES/OS/01/2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗