Ocular Discomfort
Conditions
Keywords
cationorm, artificial tear, pterygium surgery
Brief summary
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
Detailed description
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
Interventions
DRUGCationorm single-dose eye drop
Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion.
DRUGArtificial tear eye drop
Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops
Sponsors
Nguyen Viet Giap
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged 35-70 years * Having diagnosis of pterygium grade II or III and planning for pterygium surgery * Giving consent to participate the study
Exclusion criteria
* Having comorbidities that affects the corneal surface symptoms and signs * Having limitation in behavior and awareness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Sensitivity to Light symptom | 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 Blurred Vision symptom | 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 | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Discomfort when Reading | 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 Discomfort when Watching TV | 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 Discomfort when Using Computer | 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 Discomfort when Driving at Night | 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 Discomfort when Being Outdoors | 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 Discomfort when Being in Air-Conditioned Areas | 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 |
Countries
Vietnam
Outcome results
None listed