Changes of Macular Pigment Optical Density and Parameters After Nd: YAG Laser Posterior Capsulotomy in Cases With Posterior Capsule Opacification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
研究概览
简要总结
It has been hypothesized that potential effects of laser Nd: YAG laser posterior capsulotomy may affect macular pigment as well as choroidal thickness, macular thickness and anterior chamber parameters, so it was aimed to investigate possible effects of Nd: YAG laser posterior capsulotomy on macular pigment optical density, choroidal thickness, macular thickness and anterior chamber parameters in cases with posterior capsule opacification in this study.
详细描述
This clinical trial was conducted following the principles of the Declaration of Helsinki. The local authorized clinical trials ethics committee approved the protocol and consent forms (Afyon Kocatepe University Clinical Trials Ethics Committee, 2011-KAEK-2 2017/172). Between 2015 and 2016, 38 pseudophakic participants were enrolled in this study. After providing information to patients about the disease and treatment, patients predicted to show adherence to treatment, were enrolled in the study.
Detailed ophthalmological examinations of all subjects were performed prior to Nd: YAG laser posterior capsulotomy intervention. Anterior chamber parameters of cases with PCO were measured Measurements of IOP, anterior chamber parameters, visual acuity, Slit-lamp, gonioscopy and fundus examinations, and measurements of central macular thickness (CMT), choroidal thicknesses (CTs), and MPOD were performed after maximal pupil dilatation.
Proposed procedure, including risks, benefits, and alternatives were discussed with all subjects, and all participants signed of informed consent form.
Choroidal thicknesses were recorded as subfoveal CT (SCT), nasal CT (NCT) and temporal CT (TCT).
MPOD measurements were subsequently made by using luminance differential thresholds test. After measurements a refractive surgery specialist carried out Nd: YAG laser posterior capsulotomy interventions to patients who were decided to applying Nd:YAG laser capsulotomy.
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Best-corrected visual acuity (BCVA) logMAR <0.3
- •Duration at least 2 years after cataract surgery
- •Between the ages of 45 and 65 years (45≤age≤65)
排除标准
- •Corneal scarring, diffuse posterior PCO or intravitreal hemorrhage that prevents appearance of the fundus
- •Occluded angle by gonioscopy (grade 0, narrow angle, grade I, grade II)
- •Presence of macular or peripheral retinal pathologies or choroidopathy
- •High risk for RD
- •Presence of macular edema in the macular area
- •Detection of macular fluid or edema in OCT
- •Active intraocular inflammation
- •Previous laser PRP, Nd: YAG laser posterior capsulotomy, laser iridotomy or selective laser trabeculoplasty interventions
- •Previous iridectomy, glaucoma or vitreoretinal surgery
- •Glass intraocular lens
- •Spherical refractive error ≥ ±6.00 D or cylinder refractive error ≥ ±3.00 D
- •Inadequate stability of the eye
- •Systemic diseases that may affect the choroidal blood flow such as cardiological diseases
- •Current use of carotenoid supplementation
- •Changing eating habits
- •Gastrointestinal diseases that could cause disturbance of dietary absorption
研究组 & 干预措施
Nd: YAG laser posterior capsulotomy
Posterior capsulotomy was performed by using Nd: YAG laser and macular pigment optical density, intra ocular pressure, choroidal thickness, macular thickness and anterior chamber parameters were measured before Nd: YAG laser, at 1 week, 1 month and 2 months
干预措施: Nd: YAG laser posterior capsulotomy (Device)
结局指标
主要结局
Changes of Foveal and Pericentral Pigment Optical Density (Log Unit) From Baseline at 2 Months
时间窗: 2 months
Foveal and pericentral pigment optical density was measured by using color perimetry technique and recorded as log unit before Nd: YAG laser posterior capsulotomy, at 1 week, 1 month and 2 months
Changes of Subfoveal, Temporal and Nasal Choroidal Thicknesses (Micrometer) From Baseline at 2 Months
时间窗: 2 months
Subfoveal, temporal and nasal choroidal thicknesses were measured by using enhanced-deep imaging optical coherence tomography and recorded as micrometer before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Anterior Chamber Depth (Millimeter) From Baseline at 2 Months
时间窗: 2 months
Anterior chamber depth was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and at 2-month
Changes of Iridocorneal Angle From Baseline at 2 Months
时间窗: 2 months
Iridocorneal angle was measured by using anterior segment module optical coherence tomography and recorded as millimeter before Nd: YAG laser posterior capsulotomy, at 1 week, at 1-month and 2-month
次要结局
- Changes of Central Macular Thicknesses (Micrometer) From Baseline at 2 Months(2 Months)
研究者
Bunyamin Kutluksaman
Principal Investigator
Afyon Kocatepe University Hospital