Evaluate The Improvement In Symptoms Of Patients Using Cationorm After Pterygium Surgery

Nguyen Viet Giap

Status and phase: Completed; Phase 4

Conditions: Ocular Discomfort

Treatments: Drug: Artificial tear eye drop; Drug: Cationorm single-dose eye drop

Study type: Interventional

Funder types: Other

Identifiers

NCT07064187

30/BVM-KHTH No.2

Details and patient eligibility

About

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

Full 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

Enrollment: 100 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Cationorm arm

Experimental group

Description:

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

Treatment:

Drug: Cationorm single-dose eye drop

Artificial tear arm

Active Comparator group

Description:

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

Treatment:

Drug: Artificial tear eye drop