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临床试验/NCT06624384
NCT06624384尚未招募1 期

Efficacy and Safety of Topical Cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) on the Ocular Surface Symptom After Photorefractive Keratectomy (PRK) in Feiz Hospital, Isfahan, 2024

Mohsen Pourazizi1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.

研究概览

简要总结

The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. The main questions it aims to answer are:

1- Does the use of cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before photorefractive keratectomy surgery (PRK) reduce ocular surface symptom such as eye pain, redness, and inflammation in conjunctivitis in patients? Researchers will compare cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) to a placebo (Artelac artificial tears) to see if cyclosporine 0.05% and Lifitgrast works to reduce ocular surface symptom.

Participants will:

Take drug cyclosporine 0.05% and Lifitgrast or a Artelac 30 minutes before surgery Visit the clinic 6 hours, one day, three days and one week after photorefractive keratectomy (PRK) for checkups and tests

详细描述

Considering the increasing importance of reducing eye symptoms of patients after PRK surgery and the impact of this issue on the quality of life of patients, as well as the lack of sufficient studies on the effect of different drugs in this field and comparing their effects, which ultimately lead to the decision and clinical application of this Regarding the category of drugs, the present study aims to compare the administration of 2 drugs, cyclosporine 0.05% and Lifitgrast before PRK, in reducing the eye symptoms of patients after PRK.

In this study, 15 minutes before the start of photorefractive keratectomy surgery, we divide the patients into 3 random groups and according to the following plan, we put the drops into the eyes of the patients.

The first group: one eye drop cyclosporine 0.05% - opposite eye drop Lifitgrast The second group: one eye with 0.05% cyclosporine drops - the opposite eye with Artlac artificial tear drops The third group: one eye with Liffitgrast drops - the opposite eye with Artlac artificial tear drops Patients will be evaluated and examined according to variables 6 hours, one day, three days and one week after the operation. To check the symptoms of patients from standard questionnaires including Ocular surface disease index (OSDI), visual analogue scale (VAS) Wong-Baker FACES, Efron is used.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years Myopia and myopic astigmatism The stability of the patients refraction over the past year Not using contact lenses at least 3 weeks before the operation Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family No history of previous eye surgery and eye trauma Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree.
  • Absence of systemic diseases that can potentially disrupt wound healing, including diabetes, vascular collagen diseases, and pregnancy.
  • Not taking inhaled or systemic steroids actively or within 3 months before the procedure Absence of anisometropia Not using any systemic and topical analgesia during the last week

排除标准

  • The patients lack of consent to continue the study Failure to visit the patient for follow-up The occurrence of any complications during the patients surgery

研究组 & 干预措施

Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast)

Active Comparator

Group 1: In this group, cyclosporine 0.05% drops are poured into one eye and Lifitgrast drops are poured into the opposite eye.

干预措施: Group 1 drug (Drug)

结局指标

主要结局

average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.

时间窗: 1 week

The average inflammatory symptoms of the ocular surface symptoms including pain, burning and itching, redness and conjunctivitis in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy(PRK) using a standard questionnaire including Ocular Surface Disease Index (OSDI), Visual Analogue Scale (VAS), Wang Baker FACES and Efron is measured.

次要结局

未报告次要终点

研究者

发起方
Mohsen Pourazizi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohsen Pourazizi

Assistant Professor of Ophthalmology

Isfahan University of Medical Sciences

研究点 (1)

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