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临床试验/NCT03640351
NCT03640351已完成不适用

Clinical Effects of Diquas-S for Patients With Dry Eye After Cataract Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
5. Meibomian gland dysfunction (MGD) stage at postoperative 3 months among the three groups.

研究概览

简要总结

Today, cataract surgery has become one of the safest and most effective eye surgical procedures performed on many people through the development and development of surgical techniques and instruments. However, a significant number of patients who underwent cataract surgery still complain about postoperative symptoms, such as irritation, pain, dryness, burning sensation, and foreign body sensation. The reasons of dry eye (DE) development after cataract surgery include thermal and light toxicity from the microscope, corneal epithelial damage, and frequent irrigation of ocular surface during operation, sterilization of conjunctival sac and eyelid with chemicals, transection of the corneal nerves by corneal incision, use of topical anesthetics, and preservatives in topical eye drops. In this era of high expectation of patients and premium intraocular lenses, the postoperative discomforts cannot be accepted to many patients. Several studies have recently reported that the common cause of postoperative symptoms of the patients is DE. Furthermore, if the ocular surface is deformed due to DE syndrome after surgery, the optical quality is greatly affected which results in a decrease of the quality of vision. If the tear film becomes irregular, the higher-order aberration can change due to local irregular total radius of curvature of ocular surface and result in decreased visual acuity.

There have been many attempts to treat DE syndrome after cataract surgery. Artificial tears are commonly used for the first line treatment of postoperative DE and several studies revealed its effectiveness on management of DE symptoms and signs. The postoperative use of cyclosporine 0.05 % topical eye drop improved DE symptoms and visual quality after cataract surgery. Recently, diquafosol sodium ophthalmic solution has been used for the management of DE after cataract. Diquafosol is a dinucleotide derivative and functions as agonist to the purinergic P2Y2 receptor. Diquafosol is known to stimulate not only the mucin secretion from the goblet cells but also water secretion from conjunctival epithelial cells and accessory lacrimal glands. According to previous studies, diquafosol has been found to be very effective in treating DE after cataract and to alleviate symptoms of DE syndrome. Furthermore, several studies have shown that topical diquafosol has a better efficacy in managing DE after cataract surgery than artificial tears. The preservative free diquafosol ophthalmic solution has been released recently. The use of eye drops without preservatives has also been shown to play an important role in the treatment of DE after cataract surgery. Until now, there is no study that evaluated the effect of preservative free diquafosol ophthalmic solution. Thus the investigators try to investigate the efficacy of preservative free diquafosol ophthalmic solution compared to preservative containing diquafosol ophthalmic solution and sodium hyaluronate ophthalmic solution, which are widely used in patients with DE after cataract surgery.

详细描述

Enrollment period : 24 months after IRB approval Participants : The subjects over 20 years old, who visited Severance hospital for cataract surgery and has dry eye. The participants who satisfies criteria, and who can be monitored at all times during each period of observation after surgery are included in the study.

Methods: The subjects are randomly divided into three groups. Group 1 will use preservative diquafosol ophthalmic solution, Group 2 will use preservative containing diquafosol ophthalmic solution, and Group 3 will use preservative free sodium hyaluronate after cataract surgery. Before surgery, all patients underwent a detailed ophthalmological examination that included evaluation of logarithm of the minimum angle of resolution (logMAR) uncorrected-distance visual acuity (UDVA) and CDVA, manifest refraction, slit-lamp examination (Haag-Streit, Köniz, Switzerland), and dry eye parameters including tear breakup time, schirmer test, OSDI, and MGD staging. All examinations were repeated at 1, and 3 months after surgery.

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age of 20 years or older
  • dry eye patient

排除标准

  • previous use of eye drops, except artificial tears within 3 months before cataract surgery,
  • presence of severe ocular surface diseases,
  • corneal epithelial pathologies except DE syndrome
  • a history of previous ocular surgery or trauma,
  • presence of ocular comorbidities such as glaucoma, uveitis, cystoid macular edema,
  • any surgical complications including rupture of the posterior capsule during cataract surgery.

研究组 & 干预措施

Preservative free diquafosol group

Active Comparator

The subjects use preservative free diquafosol ophthalmic solution after cataract surgery

干预措施: 1. Use of preservative free diquafosol ophthalmic solution after cataract surgery (Drug)

Preservative containing diquafosol group

Active Comparator

The subjects use preservative containing diquafosol ophthalmic solution after cataract surgery

干预措施: 2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery (Drug)

Preservative free sodium hyaluronate group

Active Comparator

The subjects use preservative free sodium hyaluronate ophthalmic solution after cataract surgery

干预措施: 3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery (Drug)

结局指标

主要结局

5. Meibomian gland dysfunction (MGD) stage at postoperative 3 months among the three groups.

时间窗: postoperative 3 months

5. MGD stage is evaluated by examiner (from 0 to 4). OSDI and MGD stage is unitless. MGD stage at postoperative 3 months will be compared among the three groups.

6. Meibomian gland dysfunction (MGD) stage changes between baseline and postoperative 3 months among the three groups.

时间窗: postoperative 3 months

6 MGD stage change from baseline to postoperative 3 months will be compared among the three groups.

1. Tear break up time (TBUT) at postoperative 3 months among the three groups.

时间窗: postoperative 3 months

1. Tear break up time (TBUT) is examined using slit lamp examination, The unit of this is "sec". Tear break up time (TBUT) at postoperative 3 months will be compared among the three groups.

4. Ocular Surface Disease Index (OSDI) changes between baseline and postoperative 3 months among the three groups.

时间窗: postoperative 3 months

4. OSDI change from baseline to postoperative 3 months will be compared among the three groups.

3. Ocular Surface Disease Index (OSDI) at postoperative 3 months among the three groups.

时间窗: postoperative 3 months

3. Ocular Surface Disease Index (OSDI) is examined using questionnaire evaluating dry eye symptom of patient (from 0 to 100). Ocular Surface Disease Index (OSDI) at postoperative 3 months will be compared among the three groups.

2. Tear break up time (TBUT) changes between baseline and postoperative 3 months among the three groups.

时间窗: postoperative 3 months

2. TBUT change from baseline to postoperative 3 months will be compared among the three groups.

次要结局

  • 1. The value of total higher order aberration at postoperative 3 months among the three groups.(postoperative 3 months)
  • 2. The change of the value of total higher order aberration between baseline and postoperative 3 months among the three groups.(postoperative 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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