Repetitive contacts with UV-ray result in a shallow and painful keratopathy which takes place 6 hours after the contact with ray. It is generally agreed among the ophthalmologists that curing the minimal injuries (less than 60%) must be through chloramphenicol drop, erythromycin ointment and one cycloplegic drop in order to reduce the ciliary body spasm, and applying the bandage is still doubtful. In recent years the theory of not applying bandage on cornea injuries is becoming widely popular. The main goal of this study is designation the effect of eye patching on the improvement of corneal epithelial layer and clinical symptoms in patients with u.v keratitis. This study is one side blind in this way that examiner don’t know who of patient patch.at the first patient come to emergency unit and then visit by doctor and demolition of epithelial layer, visual actueness , pain, redness and tearing was measured with the special scalesl and patient Randomly placed into two groups one group with patch and other without patch.
in both group we use drop cholobiotic and drop homatropine 2% and eye oint erythromycin in both of eyes and patient in patching group patch up and both group give training book.we follow up patient and after 12 hours demolition of epithelial layer and all symptoms check again. Entering criteria of this study are:1. satisfaction for partnership in this study 2. Keratitis at the result of u.v 3.does not exist foreign body in eyes and exit criteria are unwillingness for partnership in this study and no readmission after 12 hours. the main intervention of this study is patching. after 12 hours demolition of epithelial layer and all symptoms check again and they are compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015092124124N1
Registration date:2015-10-27, 1394/08/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-27, 1394/08/05
Registrant information
Name
Abolfazl Rahmaninejad
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3884
Email address
rahmani.m@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Sciences
Expected recruitment start date
2015-08-22, 1394/05/31
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eye patching on the improvement of corneal epithelial layer and clinical symptoms in patients with UV keratitis
Public title
The effect of eye patching on the improvement of corneal epithelial layer and clinical symptoms in patients with UV keratitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being satisified to attend the study; the resultant keratitis of UV-ray in both eyes; using no effective drugs on clinical symptoms and curing the eye epithelial layer before going to the hospital (Anestocaine, Naphazoline and …); aged 15-65 years old; ability to see through both eyes; no enternal material or any effective disease on the eye keratitis; no doctor priscription on eye bandaging or dressing.
Exclusion criteria: no intention to continue to attend in the study in any of levels; not getting back after 12 hours; not following the therapeutic protocol; using the effective drugs on eye during the study due to any reason except the preacribed ones.
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
99
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Postal code
9691793718
Approval date
2015-03-11, 1393/12/20
Ethics committee reference number
GMU.REC.1393.142
Health conditions studied
1
Description of health condition studied
Ulta violet Keratitis
ICD-10 code
H16
ICD-10 code description
Keratitis
Primary outcomes
1
Description
the improvement of corneal epithelial layer
Timepoint
before and after intervition
Method of measurement
Examination
2
Description
pain
Timepoint
before and after intervition
Method of measurement
Visual scale of pain
3
Description
visual actueness
Timepoint
before and after intervition
Method of measurement
snelen chart
4
Description
Redness
Timepoint
before and after intervition
Method of measurement
observation
5
Description
tearing
Timepoint
before and after intervition
Method of measurement
tear break up time test
Secondary outcomes
1
Description
Improve epithelium
Timepoint
before and after intervition
Method of measurement
Determination Examination (mm)
Intervention groups
1
Description
use drop cholobiotic and drop homatropine 2% and eye oint erythromycineyes patching in patch group
Category
Treatment - Other
2
Description
use drop cholobiotic and drop homatropine 2% and eye oint erythromycin and dont patch in group without patch.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam hospital
Full name of responsible person
Abolfazl Rahmaniezhad-studene of Master of Nursing Surgical
Street address
Gharani blv., Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Ali Mohammad Pour - Vice Chancellor for Research
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Abolfazl Rahmaninezhad
Position
student of Master of Nursing Surgical
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Postal code
9691793718
Phone
+98 51 3722 3028
Fax
+98 51 3722 3814
Email
abolfazl.rahmany@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr Ali Mohammadpour
Position
PhD
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Postal code
9691793718
Phone
+98 51 3722 3028
Fax
Email
amohammadpur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Abolfazl Rahmaninezhad
Position
Master student of surgical nursing
Other areas of specialty/work
Street address
Gonabad University of Medical Sciences, Sento road
City
Gonabad
Postal code
9691793718
Phone
+98 51 3722 3028
Fax
Email
abolfazl.rahmaninejad@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)