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临床试验/NCT04977427
NCT04977427撤回4 期

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Baylor Research Institute0 个研究点目标入组 200 人开始时间: 2021年8月31日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
入组人数
200
主要终点
Optical Coherence Tomography (OCT)

研究概览

简要总结

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

详细描述

The inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. Due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. This study aims to evaluate the efficacy of Dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. If shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. Furthermore, if Dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. Risks are minimal for this FDA approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). These risks are comparable to prednisolone acetate.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Unable to fully mask to investigator in order to maintain safety (must assess the investigational Dextenza insert and its position in the lower punctum at each office visit).

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients with diagnosed diabetes
  • •Patients must be undergoing cataract surgery in each eye
  • •Patients must have no worse than moderate nonproliferative diabetic retinopathy

排除标准

  • •Patients must not have any history of documented macular edema on OCT
  • •Patients must not have any macular edema on pre-op OCT
  • •Patients must not have any history of uveitis
  • •Patients must not have severe nonproliferative or proliferative diabetic retinopathy
  • •Patients with operative complications will be excluded from this study
  • •Patients with any active corneal disease, infectious or rheumatologic, will be excluded
  • •Patients must not be pregnant

研究组 & 干预措施

Dextenza Arm

Active Comparator

Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.

干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)

Prednisolone Arm

Active Comparator

Standard post-cataract surgery therapy arm; acts as control in each patient.

干预措施: Prednisolone Acetate 1% Oph Susp (Drug)

结局指标

主要结局

Optical Coherence Tomography (OCT)

时间窗: 7 days

The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

Optical Coherence Tomography (OCT)

时间窗: 14 days

The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

Optical Coherence Tomography (OCT)

时间窗: 30 days

The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

次要结局

  • Macular Edema(30 days)
  • Macular Edema(7 days)
  • Macular Edema(14 days)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Jacob Fleenor

Resident Physician, Principal Investigator

Baylor Research Institute

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