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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Erosion; Cornea, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bandage contact lens group

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

Group Type EXPERIMENTAL

Bandage contact lens

Intervention Type DEVICE

Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)

Pressure patching group

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

Group Type ACTIVE_COMPARATOR

Pressure patching

Intervention Type DEVICE

Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.

Interventions

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Bandage contact lens

Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)

Intervention Type DEVICE

Pressure patching

Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

17 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No