Comparison of the Postoperative Use of Dextenza (Dexamethasome Ophthalmic Insert) vs a Standard Regimen of Topical Fluorometholone After PRK
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Refractive Outcomes
研究概览
简要总结
Naval Refractive Surgery Center proposes a prospective, single-site, randomized, non-FDA regulated clinical trial with bilateral commercial treatment for for PRK. Subjects will be randomized to receive one of two postoperative steroid regimens: Dextenza (a dexamethasone ophthalmic insert) or standard of care topical Fluorometholone. Subjects will be followed for 3 months after surgery. Investigators will use objective and subjective measures to assess potential differences in postoperative healing and pain.
This study will not be FDA-regulated. All study surgeries will be standard of care, with the exception of the addition of the Dextenza insert after the PRK procedure among subjects randomized to the Dextenza group.
详细描述
The Dextenza in the DoD study is a prospective, randomized, comparative, single-site, non-FDA regulated clinical trial to compare two different postoperative steroid regimens in active duty populations that are treated with PRK at the Navy Refractive Surgery Center in San Diego,California.
Study subjects will be randomly assigned to receive one of two post-PRK steroid regimens:
- Dextenza (a dexamethasone ophthalmic insert manufactured by Ocular Therapeutix)
- Standard of care topical Fluorometholone
For each study subject, both eyes will be randomized to the same postoperative steroid regimen. That is, this is a bilateral eye study (not contralateral).
The myopic treatments will range from 0.00 D to -8.00 D MRSE, with cylinder from -0.00 to - 3.00 D (myopia with or without astigmatism). This treatment range is within FDA-approved limits for PRK, as well as all proposed study lasers.
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
- None
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
- •Male and female subjects 18 years of age and older, either active duty or dependents, who are eligible for care;
- •Myopia with manifest refractions ranging from 0.00 D to -8.00 D MRSE, with astigmatism ranging from 0.00 to -3.00 D CYL.
- •A stable refraction for the past year, as demonstrated by change in Sphere of ≤ 0.50 D and/or change in Cylinder of ≤ 0.50 D in the eyes to be treated;
- •A difference between cycloplegic and manifest refractions of
- •≤ 0.75 D MRSE in both eye(s);
- •BSCVA at least 20/20 in the treated eyes;
- •Discontinue use of contact lenses for at least 4 weeks (for hard lenses) or 2 weeks (for soft lenses) prior to the preoperative examination, and through entire study. The subject shall not be considered a contact lens wearer if they are not wearing hard contact lenses for 4 weeks or soft contact lenses for 2 weeks;
- •Central corneal thickness of at least 500 microns in the both eye(s);
- •Willing and able to return for scheduled follow-up examinations;
- •Able to provide written informed consent and follow study instructions in English.
- •Permission of the Commanding Officer for active duty subjects to receive refractive surgery and participate in the study.
- •Qualifies for treatment on all study lasers within FDA-approved parameters.
排除标准
- 未提供
研究组 & 干预措施
Dextenza 0.4Mg Ophthalmic Insert
Dextenza (a dexamethasone ophthalmic insert manufactured by Ocular Therapeutix) will be inserted immediately after PRK surgery to administer a post surgery steroid regimen. No steroid drops will be adminstered.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Topical Fluorometholone
Standard of care topical Fluorometholone drops will be used by the subjects after PRK Surgery. There will be a taper as follows:
i. 1 drop in each eye QID for 1st week postop. ii. 1 drop in each eye TID for 2nd week postop. iii. 1 drop in each eye BID for 3rd week postop. iv. 1 drop in each eye qD for 4th week postop.
干预措施: Topical Fluorometholone (Drug)
结局指标
主要结局
Refractive Outcomes
时间窗: pre-op, 1 week, 1 month, 3 months
Measured in MRSE, Manifest Refraction and lines of vision loss
Self-Reported Intermediate-Term Postoperative Symptoms
时间窗: pre-op, 1 week, 1 month, 3 month
COMTOL questionnaire given to subjects at their pre and post operative visits
Epithelial Closure
时间窗: 1 week, 1 month, 3 months
Evaluated during post-op visits as yes/no. Evaluation will be done during the slit lamp examination
Self-Reported Postoperative Pain During the First Week Postoperative PRK
时间窗: week 1 post surgery
Assessed using a Take Home questionnaire for the first week postop that includes: * Visual analogue scale * Questions about medication utilization (adherence) and frequency
Incidence of Haze
时间窗: Preop, post op 1 week, 1 month, 3 months
Evaluated during the slit lamp examination and recorded as clinically significant haze Yes/no
次要结局
- Return to Duty(Pre-op, 1 week, 1 month, 3 months)