NCT00413673已完成不适用
Initial Evaluation of Photorefractive Keratectomy in U.S. Army Personnel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- safety and efficacy of PRK
研究概览
简要总结
The objective of this study is to conduct a prospective clinical trial to evaluate the safety and efficacy fo the VISX Excimer Laser system for the treatment of naturally occurring low to moderate myopia, with or without low levels of astigmatism, in U.S. Army personnel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent.
- •Normal, healthy active adults with access to medical care at Walter Reed Health Care System.
- •Age 21 years or older.
- •Spherical equivalent of the manifest refractive error between -1.0 to -6.0 diopters (D), inclusive, with no more than 3.0D of cylinder. The absolute value of the cylinder (expressed in minus cylinder) will be limited such that the short axis of the elliptical ablation will be no smaller than 4.9mm. The following specifies the maximum cylinder for a given spherical component of the manifest refraction:
- •Spherical component / Maximum cylinder
- •1.0D / -0.5D
- •2.0D / -1.0D
- •3.0D / -1.5D
- •4.0D / -2.0D
- •5.0D / -2.5D
- •6.0D / -3.0D
- •Corrected vision of at least 20/20
- •Soft contact lens users must havE removed their lenses at least two weeks prior to baseline measurements.
- •Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least four weeks prior to baseline measurements. At least two weekly manifest refractions and keratometry measurements will be required in this interval. The last two measurements must not vary by more than 0.50D in any meridian.
- •Patients undergoing orthokeratology must have their lenses removed at least 6 months prior to the baseline examination. At least two monthly manifest refractions and keratometry measurements taken after the third month out of lenses must not vary by more than 0.50D in any meridian.
- •Refractive stability must be documented by previous refractions. Spherical and cylindrical portion of the manifest refraction must not have varied by more than 0.50D over the previous 12 months.
- •Exhibits strong motivation for keeping the follow-up visits.
- •Available for evaluation at Walter Reed during the two-year follow-up period.
- •Service members must have their command approval to participate in the study.
- •Access to transportation to meet follow-up requirements.
排除标准
- •Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts.
- •Either one or both eyes suffering from chronic dryness.
- •Taking any systemic medications that may affect wound healing such as corticosteroids or antimetabolites.
- •Patient corneal neovascularization within one mm of the ablation zone.
- •History of any previous eye surgery, including previous refractive surgery.
- •Best corrected visual acuity of less than 20/
- •Progressive myopia or keratoconus.
- •Any systemic disease that may affect wound healing, such as connective tissue disorders (rheumatoid arthritis, systemic lupus erythematosus, etc.), diabetes, or severe atopic disease.
- •Any physical or mental impairment that would preclude participation in any of the examinations.
- •For contact lens users there must be no evidence of contact lens corneal warpage on computerized topography.
- •Currently on flight status or projected to be on flight status within ten years.
- •Pregnant or breast-feeding an infant. Women of childbearing age must take a urine blood pregnancy test before starting this study
结局指标
主要结局
safety and efficacy of PRK
时间窗: 12 months after surgery
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Evaluation of Conventional Photorefractive Keratectomy (PRK) in U.S. Army Personnel, Substudy of: Initial Evaluation of Excimer Laser Keratorefractive Surgery in U.S. Army PersonnelMyopiaNCT00412568Walter Reed Army Medical Center150
已完成
3 期
Prospective Evaluation of Radial Keratotomy (PERK) StudyMyopiaNCT00000129National Eye Institute (NEI)
进行中（未招募）
不适用
Epi-on PiXL for the Treatment of Progressive Keratoconus.Corneal CrosslinkingCorneal DensitometryScheimpflug PhotographyCorneal DisorderEye DiseasesKeratoconusNCT04668924Umeå University32
已完成
不适用
Refractive Transepithelial Photo-keratectomy (T-PKR) in High MyopiaOphthalmopathyKeratopathyMyopiaNCT04917562Centre Hospitalier Régional Metz-Thionville38
已完成
不适用
Efficiency, Predictability and Security of the Trans-epithelial Photorefractive KeratectomyMyopiaNCT02893592Centre Hospitalier Régional Metz-Thionville118