Evaluate The Improvement In Symptoms Of Patients Using Cationorm After Pterygium Surgery
NCT ID: NCT07064187
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2022-06-15
2022-08-15
Brief Summary
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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
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Detailed Description
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* 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
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
Cationorm single-dose eye drop
Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion.
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
Artificial tear eye drop
Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops
Interventions
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Cationorm single-dose eye drop
Cationorm single-dose eye drop is a preservative-free, cationic oil-in-water nano-emulsion.
Artificial tear eye drop
Artificial tear eye drops are hyaluronic acid, polymers or cellulose derivatives eye drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Having diagnosis of pterygium grade II or III and planning for pterygium surgery
* Giving consent to participate the study
Exclusion Criteria
* Having limitation in behavior and awareness
35 Years
70 Years
ALL
No
Sponsors
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Nguyen Viet Giap
OTHER
Responsible Party
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Nguyen Viet Giap
Director of Hospital
Locations
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Ba Ria - Vung Tau Eye Hospital
Bà Ria, Ba Ria - Vung Tau, Vietnam
Countries
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References
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Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Other Identifiers
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30/BVM-KHTH No.2
Identifier Type: -
Identifier Source: org_study_id
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