Evaluate The Improvement In Symptoms Of Patients Using Cationorm After Pterygium Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency and Severity of Blurred Vision symptom
研究概览
简要总结
The goal of this interventional clinical trial is to learn whether Cationorm can improve symptoms after pterygium surgery. The main question it aims to answer is what is the level of improvement of symptoms after pterygium surgery.
Researchers will compare with other artificial tears (hyaluronic acid, polymers or cellulose derivatives eye drops) arm to see if Cationorm is similar or superior in terms of improvement of symptoms after pterygium surgery.
Participants will
- Take 1 drop Cationorm/artificial tear before and after surgery and during follow up.
- Visit for checkups after 7 days
详细描述
Participants will take:
- Before surgery: 1 drop Cationorm/artificial tear at the eye that will undergo surgery
- After surgery: 1 drop Cationorm/artificial tear at the eye that underwent surgery before eye bandages
- Follow up after surgery: 1 drop Cationorm/artificial tear 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
- Maintenance phase: 7-14 days with the same regimen
- After day 5, if fluorescein staining (-), can add corticosteroid monotherapy or addition with antibiotics
- After 5 days of surgery, can add more antibiotics depend on the symptoms of patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 35-70 years
- •Having diagnosis of pterygium grade II or III and planning for pterygium surgery
- •Giving consent to participate the study
排除标准
- •Having comorbidities that affects the corneal surface symptoms and signs
- •Having limitation in behavior and awareness
研究组 & 干预措施
Cationorm arm
Participants will take:
- Before surgery: 1 drop Cationorm at the eye that will undergo surgery
- After surgery: 1 drop Cationorm at the eye that underwent surgery before eye bandages
- Follow up after surgery: 1 drop Cationorm 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
- Maintenance phase: 7-14 days with the same regimen
干预措施: Cationorm single-dose eye drop (Drug)
Artificial tear arm
Participants will take:
- Before surgery: 1 drop artificial tear at the eye that will undergo surgery
- After surgery: 1 drop artificial tear at the eye that underwent surgery before eye bandages
- Follow up after surgery: 1 drop artificial tear 4-6 times/day alternating with antibiotics (third-fourth generation quinolone) with 2-hour interval between drops
- Maintenance phase: 7-14 days with the same regimen
干预措施: Artificial tear eye drop (Drug)
结局指标
主要结局
Frequency and Severity of Blurred Vision symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
Frequency and Severity of Eye Pain symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
Frequency and Severity of Grittiness symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
Frequency and Severity of Watery Eyes symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
Frequency and Severity of Itchiness symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
Frequency and Severity of Sensitivity to Light symptom
时间窗: From enrollment to 7 days after surgery
All study outcomes are collected using modified OSDI questionnaire answered by patients before surgery, after surgery and 7 days after surgery. These outcomes includes the frequency and severity of: * Symptoms: Blurred Vision, Eye Pain, Watery Eyes, Itchiness, Grittiness, Sensitivity to Light * Impact on daily life activities: Discomfort when Reading, Discomfort when Watching TV, Discomfort when Using Computer, Discomfort when Driving at Night, Discomfort when Being Outdoors, Discomfort when Being in Air-Conditioned Areas Frequency: Never, Some of the time, Most of the time, All of the time Severity: None, Mild, Moderate, Severe
次要结局
- Frequency and Severity of Discomfort when Reading(From enrollment to 7 days after surgery)
- Frequency and Severity of Discomfort when Being Outdoors(From enrollment to 7 days after surgery)
- Frequency and Severity of Discomfort when Watching TV(From enrollment to 7 days after surgery)
- Frequency and Severity of Discomfort when Using Computer(From enrollment to 7 days after surgery)
- Frequency and Severity of Discomfort when Driving at Night(From enrollment to 7 days after surgery)
- Frequency and Severity of Discomfort when Being in Air-Conditioned Areas(From enrollment to 7 days after surgery)
研究者
Nguyen Viet Giap
Director of Hospital
Ba Ria - Vung Tau Eye Hospital