Dextenza Versus Topical Steroid Eye Drops for Postoperative Management Following Corneal Crosslinking

Официальное название

Comparison of Intracanalicular Steroid-eluting Insert (Dextenza) to Topical Steroid Eye Drops for the Postoperative Management of Corneal Collagen Crosslinking

Обзор

This study aims to compare the use of Dextenza, an FDA-approved intracanilular drug-eluting insert that is designed to deliver a tapered dose of dexamethasone to the ocular surface for 30 days, to the standard of care, or the use of a month-long topical prednisolone acetate 1% (PredForte) eye drops starting from four times daily. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. Three prior phase 3 clinical trials have demonstrated that Dextenza is equally efficacious to a month-long topical Pred Forte taper in the treatment of postoperative inflammation following cataract surgery. This proposed study strives to demonstrate the non-inferiority of using Dextenza to treat postoperative inflammation following corneal collagen crosslinking compared to standard of care eye drops in a randomized trial. By demonstrating Dextenza's non-inferiority to treatment postoperative inflammation, the investigators hope to provide an alternative modality of treatment to patients who are unable to cooperate with or tolerate postoperative topical eye drop regimens, allowing for improved adherence to necessary therapy and thus improved postoperative outcomes.

Вмешательства

• Препарат Dextenza 0.4Mg Ophthalmic Insert
  This insert allows for sustained release of dexamethasone onto the ocular surface over a period of 28 days. It requires a single application and eliminates the potential for noncompliance, difficulty in administration and poor accuracy. Dextenza has been FDA approved for post-operative pain and inflammation following ophthalmic surgery. The pivotal trials included patients undergoing cataract surgery, not CXL surgery. In addition, the age range did not include those of pediatric age.
• Препарат topical prednisolone acetate 1% (PredForte) eye drops
  The patient will administer the anti-inflammatory steroid drops on the same 4 week post-operative schedule that is commonly used in standard of care. They will do one drop of Pred Forte in the affected eye 4 times a day for a week, 3 times a day for the second week, 2 times a day for the third week, and once a day for the fourth week.

Первичные конечные точки

• Corneal haze [Срок оценки: 1 months (30 days)]
• Corneal re-epithelialization [Срок оценки: 6 months (180 days)]
• Keratometry [Срок оценки: 6 months (180 days)]
• Infection [Срок оценки: 6 months (180 days)]

Вторичные конечные точки (7)

• Comfort [Срок оценки: 6 months (180 days)]
• Ocular Pain Assessment [Срок оценки: 6 months (180 days)]
• Ease of insertion [Срок оценки: 6 months (180 days)]
• Comparison of Ophthalmic Medications for Tolerability Questionnaire [Срок оценки: 6 months (180 days)]
• IOP spikes incidence [Срок оценки: 6 months (180 days)]
• Anterior segment OCT [Срок оценки: 6 months (180 days)]
• Best Corrected Visual Acuity [Срок оценки: 6 months (180 days)]

Критерии участия

Критерии включения

• The study will enroll patients age 13 and up with progressive keratoconus (KCN) who are scheduled for bilateral epithelial off corneal collagen cross-linking (CXL) with Photrexa. A patient's study eye must meet the following criteria to be eligible for inclusion in the study:

• Progressive keratoconus as defined by increasing astigmatism and/or keratometry on corneal topography or tomography or increasing cylindrical error on refraction
• Patients requiring general anesthetic for the procedure
• Preoperative central corneal thickness of >= 400 microns

Критерии исключения

• History of acute hydrops in treated eye
• History of pre-existing severe corneal scarring in the treated eye
• History of pre-existing glaucoma in the treated eye
• History of or pharmaceutical treatment of glaucoma or ocular hypertension and history or current spikes in intraocular pressure (IOP) in either eye.
• History of pre-existing ocular inflammation or infection (conjunctivitis, keratitis, uveitis, or retinitis) in treated eye
• Active infectious systemic disease
• Obstructed nasolacrimal duct in the study eye(s)
• Patients with a nasolacrimal duct smaller than 0.4 mm or greater than or equal to 1.0 mm.
• Patients with stenosis to the location where the insert will be placed should be excluded from the study, as the study team would not engage in surgical procedures to expand or surgically correct that region
• Hypersensitivity to dexamethasone
• Patients being treated with immunomodulating agents in the study eye(s)
• Patients being treated with immunosuppressants and/or oral steroids
• Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator

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

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Mission Bay Hospital — San Francisco
• UCSF Pediatric Ophthalmology — San Francisco
• Wayne and Gladys Center for Vision — San Francisco

Идентификаторы

NCT: NCT06235567 · 23-40498

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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