Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative SOC

Официальное название

Prospective Study of Complication Rates in Cataract Surgery Patients Treated With Combined Pre-operative NSAID, OMIDRIA, and Subconjunctival Triamcinolone Acetonide Compared With Peri-operative Standard of Care

Обзор

This is a multicenter, 2-arm, randomized, prospective study of patients slated for bilateral cataract extraction. One eye will be randomized to the Study Arm, and the fellow eye will be randomized to the Control Arm.

Подробное описание

For the control arm interventions:

Preoperatively, the Control Arm (control eye) will self-administer a regimen of ketorolac four times daily (QID) x 1 day and moxifloxacin drops three times daily (TID) x 1 day before surgery. On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule:

* In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate

Eyes in the Control Arm will then self-administer the following postoperative interventions: ketorolac drops QID x 1 month, prednisolone acetate tapering QID x1 week, TID x 1 week, twice daily (BID) x 1 week, and once daily (QD) x 1 week; and moxifloxacin drops TID x 1 week.

For the study arm interventions:

Eyes will receive in-office drops on the Day of Surgery administered by study staff according to the following schedule:

* In pre-operative holding: 1 drop ketorolac, 1 drop moxifloxacin * Immediately prior to surgery: 1 drop ketorolac, 1 drop moxifloxacin * At the conclusion of surgery while still in the operating room: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate * Any time in postoperative recovery: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.

Eyes in the Study Arm will be treated with the following intraoperative interventions: intracameral phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin, and subconjunctival triamcinolone acetonide.

The following study assessments will take place for all subjects:

Visual acuity measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart (pinhole visual acuity \[VA\] or best corrected visual acuity \[BCVA\])

* Slit lamp examination, including intraocular pressure (IOP) measurement * Grading of inflammation * Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire * Pain assessment on a 0-4 scale * Overall participant satisfaction on a 0-10 scale * Optical coherence tomography (OCT) imaging

Eyes in the Study Arm will also receive in-office drops administered by study staff at the end of the 1-day visit: 1 drop ketorolac, 1 drop moxifloxacin, 1 drop prednisolone acetate.

Rescue therapy for postoperative inflammation will be allowed for Study Arm participants, if necessary, at the discretion of the evaluating physician and will consist of prednisolone acetate QID (taper also at the discretion of the evaluating physician).

Вмешательства

• Препарат Omidria, {0.3%-1% Intraocular Solution}, VIGAMOX {0.5% moxifloxacin hydrochloride}, Kenalog {0.4 ml, 10mg/ml, triamcinolone acetonide}
  Eyes in the Study Arm will be treated with the following intraoperative interventions: Intracameral (OMIDRIA) phenylephrine 1.0%/ketorolac 0.3%, intracameral moxifloxacin (0.5%), and subconjunctival triamcinolone acetonide (0.4 mL, 10mgs/mL).
• Препарат Ketorolac (0.5%) {Toradol}, moxifloxacin (0.5%) {VIGAMOX}, prednisolone acetate (1%) {Pred Forte}
  On the Day of Surgery, eyes in the Control Arm will receive in-office drops administered by study staff according to the following schedule: * In pre-operative holding: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * Immediately prior to surgery: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%) * At the conclusion of surgery while still in the operating room: 1 drop ketorolac (0.5%), 1 drop moxifloxacin (0.5%), 1 drop prednisolone acetate (1%) * Any time in postoperative recovery: 1 dr

Первичные конечные точки

• inflammation [Срок оценки: 8 days]

Вторичные конечные точки (1)

• SPEED Questionnaire [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Adult participants > 18 years of age undergoing bilateral cataract surgery
• Able to provide written informed consent prior to any study related procedure
• Able and willing, as assessed by the Investigator, to follow study instructions, complete study assessments, comply with the protocol, and attend study visits for the duration of the study
• Patients deemed to be "higher risk" for postoperative complications (e.g., well-controlled diabetes (HbA1c ≤7.0), history of uveitis, history of retinal vein occlusion, history of epiretinal membrane, history of vitreomacular traction, evidence of posterior synechiae, etc.) MAY be enrolled provided there has been no evidence of active disease or treatment in the prior 12 months
• Participants who do not meet the exclusion criteria may be enrolled.

Критерии исключения

• Cataract surgery combined with any other procedure (e.g., glaucoma, retina, etc.)
• Glaucoma patients or known steroid responders
• Oral anti-inflammatory medications to treat a systemic disease (exceptions to this include 81 mg aspirin, ibuprofen for headache, etc.)
• Intraocular injection within 6 months
• Any prior ocular implant
• Diagnosis of retinal thickening in the study eye within 12 months of enrollment
• Inability to provide informed consent
• Participation in another clinical trial

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

Лечение

Центры проведения

США · 2 центра

• The Eye Associates - Venice — Venice
• The Eye Centers of Racine & Kenosha — Racine

Идентификаторы

NCT: NCT06681688 · MSS V2 6324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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