Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients

Udayana University

Status and phase: Completed; Phase 3

Conditions: Erosion; Cornea, Traumatic

Treatments: Device: Pressure patching; Device: Bandage contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT01809483

LB0201/IIC5D11/16095/2012

Details and patient eligibility

About

This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

Full description

This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment

Enrollment: 32 patients

Sex: All

Ages: 17 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 17-55 years
• onset of corneal erosion < 48 hours
• corneal erosion due to mechanical injury
• extensive corneal erosion > 3 mm2

Exclusion criteria

• bilateral corneal erosion
• corneal erosion due to chemical or thermal injury
• history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
• history of systemic or topical antibiotics within 1 week prior to the examination
• other abnormalities due to trauma
• palpebral or eyelashes position abnormalities
• anterior segment infections
• tear break-up time < 7 seconds in the contra lateral eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

32 participants in 2 patient groups

Bandage contact lens group

Experimental group

Description:

subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and bandage contact lens. Bandage contact lenses maintained for 24 hours. Antibiotic eye drops were instilled without removing the contact lenses

Treatment:

Device: Bandage contact lens

Pressure patching group

Active Comparator group

Description:

Subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and pressure patching. Pressure patching maintained for 24 hours and only opened for drug application. Subject and their families were educated on how to perform a good pressure patching

Treatment:

Device: Pressure patching