The Impact of Physiologic Cataract Surgery on Patient Comfort and Medication Usage

Обзор

The study will pertain to investigating the impact of high vs low IOP on the intraoperative experience and comfort for the patient and surgeon. Our hypothesis is that operating at a more physiological IOP using Unity VCS/CS and Centurion with Active Sentry at a higher, or more traditional IOP will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.

Подробное описание

Objective/ Unmet Medical Need:

To investigate the impact of Unity VCS/CS with Intelligent Fluidics at a low IOP setting and Centurion with Active Sentry at a traditionally high IOP setting on the intraoperative experience for the patient and surgeon. Limited research on phacoemulsification at near physiological IOP and its impact on patient discomfort/pain using the Unity VCS/CS system.

Design:

Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to high (IOP 65mmHg) or low (IOP 25mmHg) IOP, contralateral eye will receive other treatment.

STUDY HYPOTHESIS Unity VCS/CS with Intelligent Fluidics during cataract surgery will result in significantly less discomfort/pain as assessed by the decreased need for rescue medication and lower VAS scores.

Вмешательства

• Устройство High IOP Setting
  Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment
• Устройство Low IOP Setting
  Prospective, single-surgeon, eyes undergoing phacoemulsification will be randomized to low (IOP 25mmHg) or high (IOP 65mmHg) IOP, contralateral eye will receive other treatment

Первичные конечные точки

• Rescue Medication [Срок оценки: During cataract surgery]

Вторичные конечные точки (7)

• VAS Pain Score [Срок оценки: During Phaco, I/A, and Visco Removal]
• Surgeon Intraoperative Experience [Срок оценки: During cataract surgery]
• Cost Analysis [Срок оценки: During cataract surgery]
• Breakthrough pain and discomfort High Axial Length [Срок оценки: During cataract surgery]
• 1 day Post Op Patient Survey [Срок оценки: 1 day post op cataract surgery, each eye]
• Anesthesiologist Review Blood Pressure [Срок оценки: During cataract surgery]
• Anesthesiologist Review Pulse Rate [Срок оценки: During cataract surgery]

Критерии участия

Inclusion Criteria: Subjects who will require bilateral cataract surgery will be considered. Evaluations will occur in the clinic of the Principal Investigator (PI) Matthew Rauen, MD at the Wolfe Eye Clinic.

Критерии включения

• Visually significant cataract 2-3+ undergoing uncomplicated cataract surgery with similar cataract grade in both eyes
• Unremarkable ocular health but inclusive of early AMD

Критерии исключения

• H/o ocular surgery including corneal refractive surgery
• Compromised zonular integrity or stability
• Uncontrolled diabetes and diabetic retinopathy
• Small pupils
• H/o systemic inflammatory disease/uveitis
• H/o chronic pain medications (including narcotics) and benzodiazepine usage
• Abnormal liver or renal function

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Wolfe Eye Clinic and Wolfe Surgery Center — West Des Moines

Публикации

• Liu YC, Setiawan M, Ang M, Yam GHF, Mehta JS. Changes in aqueous oxidative stress, prostaglandins, and cytokines: Comparisons of low-energy femtosecond laser-assisted cataract surgery versus conventional phacoemulsification. J Cataract Refract Surg. 2019 Feb;45(2):196-203. doi: 10.1016/j.jcrs.2018.09.022. Epub 2018 Dec 6. PMID 30528516
• Scarfone HA, Rodriquez EC. Evaluation of Early Changes of the Anterior Vitreous Interface after Cataract Surgery, using Low-Pressure Settings Determined by OCT. ASCRS 2023 May 6, San Diego Convention Center. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/88373
• Donnenfeld ED, Mychajlyszyn D, Mychajlyszyn A, Stein R. Pain control and reduction of opioid use associated with intracameral phenylephrine1.0%-ketorolac 0.3% administered during cataract surgery. J Cataract Refract Surg. 2022 Jul 1;48(7):759-764. doi: 10.1097/j.jcrs.0000000000000855. Epub 2021 Oct 29. PMID 34860481
• Reddy AJ, Dang A, Dao AA, Arakji G, Cherian J, Brahmbhatt H. A Substantive Narrative Review on the Usage of Lidocaine in Cataract Surgery. Cureus. 2021 Oct 30;13(10):e19138. doi: 10.7759/cureus.19138. eCollection 2021 Oct. PMID 34737914
• Crandall AS, Zabriskie NA, Patel BC, Burns TA, Mamalis N, Malmquist-Carter LA, Yee R. A comparison of patient comfort during cataract surgery with topical anesthesia versus topical anesthesia and intracameral lidocaine. Ophthalmology. 1999 Jan;106(1):60-6. doi: 10.1016/S0161-6420(99)90007-6. PMID 9917782
• Gills JP, Cherchio M, Raanan MG. Unpreserved lidocaine to control discomfort during cataract surgery using topical anesthesia. J Cataract Refract Surg. 1997 May;23(4):545-50. doi: 10.1016/s0886-3350(97)80211-8. PMID 9209989

Идентификаторы

NCT: NCT07223866 · IIT #98621123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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