Analysis of the Efficacy and Safety of Intense Pulsed Light Treatment for the Ocular Surface in Patients Who Will Undergo Laser Refractive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- OSDI questionnaire
研究概览
简要总结
Dry eye is often reported as the most common complication after a laser refractive surgery. Any refractive procedure can lead an impact on the corneal surface and the tear film.
The main cause of this dry eye is the corneal denervation caused by the destruction of the anterior stromal nerves during the ablative procedure. This loss of corneal sensitivity leads to a decrease in the blink reflex, a decrease in the secretion rate of the meibomian glands and finally an evaporated dry eye. There is also a chronic inflammation at the corneal surface that produces an increase of inflammatory cytokines and a dysfunction of the meibomian glands.
Yu et al have described incidences of dry eye closed to 60% after the first month of LASIK. Hovanesian et al have observed dry eye symptoms in 50% of patients 6 months after surgery. Donnenfeld et al describe 15% of moderate dry eye in the following 3 months and 5% of severe dry eye in the first 6 months. A small number of patients will present with chronic dry eye symptoms for more than 1 year. Bower et al analyzed its incidence in 0.8% Alterations in the tear film also decrease the quality of the retinal image and produce greater number of high-order due to the irregular.
Pulsed light therapy (IPL) applied preoperatively in patients who undergo a laser refractive surgery may prevent the post-surgical dry eye and improve the refractive results. The aim of our study is to evaluate the usefulness of the applied therapy for the prevention of dry eye in patients that undergo a corneal refractive procedure.
详细描述
- Design Clinical experimental controlled trial, double-blind in which participants will be randomized into 2 groups: a study group (IPL + laser refractive surgery) and a control group (laser refractive surgery without IPL).
The study will be conducted in accordance with Law 14/2007 of 3 July, on Biomedical Research, the Declaration of Helsinki (October 2013 version), standards of Good Clinical Practice and legislation in this area.
All participants included in the study should read the Information Sheet and sign the informed and voluntary consent. 2. Participants Participants from Vissum Clinic that present the inclusion criteria and none of the exclusion criteria.
The investigators will start the study with a preliminary project and depending on the results obtained, the investigators will apply these values to calculate the final sample size using the T-student-Fischer test for unilateral hypotheses and for a type 1 or α error of 5%. and a type 2 or β error of 20%. 3. Parameters evaluated Primary measures: age, sex, skin phototype, visual acuity with and without correction, refraction, cycloplegic refraction, OSDI and VAS questionnaire, use of artificial tears, oxford scale, lacrimal meniscus height, tear break-up time, conjunctival hyperemia, meibography and slit lamp examination.
Secondary measures: corneal topography and tomography (MS-39, CSO, Italy), corneal aberrometry (MS-39, CSO, Italy), ocular aberrometry (Osiris, CSO, Italy), analysis of contrast sensitivity (CSV-1000, Vector vision), photographic capture of the epithelial defect in PRK, pre-surgical and postsurgical photographic capture of the eyelid changes in PRK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 years of age who are undergoing a corneal laser refractive surgery after a medical indication by the Vissum ophthalmologist
排除标准
- •Pregnancy
- •Piercings
- •Fitzpatrick skin classification V and VI
- •Autoimmune diseases
- •Previous history of herpes or ocular pathology
- •Pathological or suspicious corneal topography
- •Treatment in the previous month with corticosteroids, antihistamines or topical vasoconstrictors.
结局指标
主要结局
OSDI questionnaire
时间窗: 0 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Change from Baseline Lacrimal meniscus height
时间窗: 180 day
Measured in millimeters, a value greater than 0.20 mm is considered normal
Tear Break-up-time
时间窗: 0 day
Time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Change from Baseline Tear Break-up-time
时间窗: 180 day
time elapsed from the last blink to the appearance of the first tear discontinuity measured by Ocular Keratograph 5M. A title longer than 5 seconds is considered normal.
Upper and lower meibography
时间窗: 0 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline Upper and lower meibography
时间窗: 180 day
Measured by Oculus Keratograph 5M. Observes and evaluates morphological changes of the meibomian glands Meiboscore classification * Grade 0: no loss of meibomian glands. * Grade 1: loss of less than 1/3 of the total surface of the meibomian glands. * Grade 2: loss of 1/3 to 2/3 of the total area. * Grade 3: loss of more than 2/3 of the surface.
Change from Baseline OSDI questionnaire
时间窗: 180 day
It measures the severity of ocular surface symptoms and includes 12 items organized into 3 subscales; eye discomfort, functionality and environmental factors. After completing the questionnaire, a final score is obtained that when it is higher than 13 indicates ocular surface pathology.
Lacrimal meniscus height
时间窗: 0 day
Measured in millimeters by Ocular Keratograph 5M, a value greater than 0.20 mm is considered normal
Conjunctival and ciliary hyperemia.
时间窗: 0 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
Change from Baseline Conjunctival and ciliary hyperemia.
时间窗: 180 day
Grade of red eye measured by Ocular Keratograph 5M. Jenvis ranking from 0 to 4 (normal, mild, moderate, severe)
次要结局
- Change from Baseline Visual acuity(180 day)
- Visual acuity(0 day)
- VAS questionnaire(0 day)
- Corneal topography(0 day)
- Change from Baseline Corneal topography(180 day)
- Analysis of contrast sensitivity(0 day)
- Change from Baseline VAS questionnaire(180 day)
- Change from Baseline Analysis of contrast sensitivity(180 day)
- Corneal aberrometry(0 day)
- Change from Baseline Corneal aberrometry(180 day)