Zero CDE Technique for Lens Removal During FLACS

Официальное название

Zero CDE Technique for Lens Nucleus Removal During Femtosecond Laser-Assisted Cataract Surgery

Обзор

The Zero CDE (cumulative dissipated energy) technique facilitates cataract removal with no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye. In the investigator's experience, this technique consistently shows a stable anterior chamber, a low complication rate, and a rapid return of vision following cataract surgery. This prospective study aims to document the outcomes with the zero CDE technique during femtosecond laser-assisted cataract surgery (FLACS).

Вмешательства

• Процедура Femtosecond laser-assisted cataract surgery using Zero CDE
  In this single-arm, non-comparative study, patients with cataract grade 1-3 (LOCS III nuclear sclerosis) will undergo cataract removal with the Zero CDE technique that involves no or minimal phaco energy. This is facilitated by a femtosecond laser, which pre-divides the cataractous lens nucleus into multiple small segments that can be aspirated without phaco energy being delivered to the eye.

Первичные конечные точки

• % of cataract cases completed with Zero CDE [Срок оценки: Intraoperative]

Вторичные конечные точки (5)

• Among the cataract cases with zero CDE, o the average amount of balanced salt solution (BSS) (ml) used per case. [Срок оценки: Intraoperative]
• Among the cataract cases with zero CDE o % of cataract cases with corneal edema at one-day postop. [Срок оценки: Postoperative Day 1]
• Among the cataract cases with zero CDE o % of cataract cases with CME at any time up to 3 months postop. [Срок оценки: Postoperative 2 weeks, 1 month and 3 months]
• Among the cases requiring CDE, the amount of phaco energy used [Срок оценки: Intraoperative]
• Incidence of adverse events [Срок оценки: Intraoperative, and postoperative Day 1, 2 weeks, 1 month, and 3 months]

Критерии участия

Критерии включения

• Adult patients over the age of 50 years with operable cataract of nuclear sclerosis grade 1 to 3 as measured by LOCS III grading system (patients with cortical or posterior subcapsular cataract of any grade will be eligible).
• Patients must be able to provide written informed consent for participating in the study.
• Preoperative best corrected visual acuity of 20/25 or worse.

Критерии исключения

• Patients with corneal edema, corneal guttata, pseudoexfoliation, zonular dialysis, or other ocular anomalies (e.g., inflammation, uveitis, previous trauma, suspected microbial infection, glaucoma, and macular disease).
• Patients wearing soft contact lenses will need to discontinue lens wear for 2 weeks, and hard contact lens wearers for one month prior to intraocular lens measurements.
• Women patients of childbearing potential.
• Patients undergoing arcuate keratotomy or other combined surgery with cataract.

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

Канада · 1 центр

• Bochner Eye Institute — Toronto

Идентификаторы

NCT: NCT07404293 · RS/2024/01 version 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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