Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Pediatric Refractive Error Profile(PREP) questionnaire score
研究概览
简要总结
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28
详细描述
Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression. Several clinical studies have shown that overnight wear of Orthokeratology lenses (OK) is an effective method of slowing myopia progression in adolescents.However, wearing corneal contact lenses tends to interfere with tear homeostasis, which may lead to ocular discomfort, dryness, and ocular surface disorders. More than 50% of contact lens wearers report symptoms of dry eye.Prolonged contact with the cornea can have an effect on the corneal layer.With the rapid increase in the use of OK lenses worldwide, potential complications have become a major concern for parents. Potential complications include keratitis and corneal epithelial damage. In addition, overnight OK lens wear has been associated with decreased tear production and reduced tear film stability. Recently, a four-week study by Carracedo et al. demonstrated that OK lens wear did not significantly change fluorescein-stained tear film breakup time or Schirmer's test I results, but subjects had increased dry eye symptoms one month after wear Decrease in cupped cell density.
Diquafosol Ophthalmic Solution (DQS) is a potent purinergic P2Y2 receptor agonist, a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5'-triphosphate; it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells. Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye. In addition, some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night. However, the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses. The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 8-18 years old
- •Wearing corneal shape mirror more than one year and at least eight hours every night
- •Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.
- •Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.
- •Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.
排除标准
- •Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
- •Pathological changes in the corneal rim
- •Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
- •Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
- •Have received any other eye treatment or surgery
研究组 & 干预措施
DQS group
Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co.,Ltd., Osaka, Japan) six times per day for 4 weeks
干预措施: 3% Diquafosol tetrasodium (Drug)
结局指标
主要结局
Pediatric Refractive Error Profile(PREP) questionnaire score
时间窗: Day-0 (baseline), 2-weeks, 4-weeks
Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.
次要结局
- Ocular Surface Disease Index(OSDI) questionnaire score(Day-0 (baseline), 2-weeks, 4-weeks)
- Tear Film Lipid Layer(Day-0 (baseline), 2-weeks, 4-weeks)
- Non-invasive tear break-up time(Day-0 (baseline), 2-weeks, 4-weeks)
- Tear meniscus height(Day-0 (baseline), 2-weeks, 4-weeks)
- Objective visual quality assessment(Day-0 (baseline), 2-weeks, 4-weeks)
- Conjunctivocorneal staining grade(Day-0 (baseline), 2-weeks, 4-weeks)