Evaluation of the results of treatment of eye surface changes after designing and evaluating the recommended self-care system in patients with dry eye
Design
A clinical trial with a control and intervention group،superior, phase 3 on 104 patients, with a parallel group, one-way blind, www.randomization.com is used for randomization.
Settings and conduct
Patients after the initial visit and performing a clinical test that leads to the diagnosis of dry eye disease by the treating physician in the specialized ophthalmology clinic of Nourafarin. The patient is given a number that may be in the control or intervention group and then according to the group assigned to the patient, the treatment process is continued for 3 months and the results of clinical tests and questionnaires for the first week and 6 and 12 patients are taken. Correction is used at the analyst level.
Participants/Inclusion and exclusion criteria
Inclusion requirements included
• Patients who have been diagnosed with dry eye based on diagnostic criteria and are over 18 years of age.
• Patients who are literate, have access to a smart phone, and have the satisfaction and motivation to participate in the study and do not have mental disorders.
Exclusion requirements included
Simultaneity of two designs. Dissatisfaction with participating in a research project and receiving training. Patients who are unable to read and use the Internet and electronic devices due to the high severity of dry eye disease.
Intervention groups
In the intervention group, in addition to receiving the doctor's advice during the visit, a mobile application is installed on their mobile phone .
In the control group, the doctor's recommendations are presented during the patient's visit.
Main outcome variables
The main outcome of the tear film evaporation test is a clinical test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200721048162N1
Registration date:2020-08-31, 1399/06/10
Registration timing:registered_while_recruiting
Last update:2020-08-31, 1399/06/10
Update count:0
Registration date
2020-08-31, 1399/06/10
Registrant information
Name
Maryam Edalati khodabandeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3622 4876
Email address
edalatim961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
evaluation of educational intervention based on self-care system on Tear breakup time (TBUT) in patients with dry eye .
Public title
evaluation of educational intervention based on self-care system on Tear breakup time (TBUT) in patients with dry eye .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with dry eye based on diagnostic criteria
Patients who were satisfied and motivated to participate in the study.
Patients who are at least 18 years old and do not have mental disorders.
Patients who have access to and are able to use a smart phone.
Patients who are literate.
Exclusion criteria:
Participate in another similar project at the same time.
Dissatisfaction with participating in a research project and receiving training
Patients who are unable to read and use the Internet and electronic devices due to the high severity of dry eye disease.
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table using WWW.randomization.com where these numbers are placed in an envelope.
The method of the envelope is that the envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomize.com site and will be placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if he wishes, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope.
Allocation Concealment: Sealed envelopes
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the data analyst is blinded. At the end of the research, the data will be provided to them for statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 71, 50st St .Shahed Blvd. Ghasem Abad ., Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9186144811
Approval date
2020-03-22, 1399/01/03
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.210
Health conditions studied
1
Description of health condition studied
dry eye
ICD-10 code
(H04.1)
ICD-10 code description
Dry Eye Syndrome
Primary outcomes
1
Description
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease
Timepoint
It is measured at the beginning of the study (before the start of the study) and the sixth week and the 12th week after the start of using the software system.
Method of measurement
Using a Keratograph device
Secondary outcomes
1
Description
The Ocular Surface Disease Index (OSDI) .
Timepoint
It is measured at the beginning of the study (before the start of the study) and the sixth week and 12 weeks after using the software system.
Method of measurement
Short questionnaire 12 questions:The Ocular Surface Disease Index (OSDI)
Intervention groups
1
Description
"Intervention group:" After the initial visit and performing the basic dry eye tests, the training and recommendations are expressed orally by the doctor and then the designed software is installed on the patients' mobile phones and medical recommendations are sent to the patient for 3 months. During the process of using mobile software, the usual process of dry eye treatment, including the use of prescription drugs by an ophthalmologist will continue.
Category
N/A
2
Description
"Control group:" After the initial visit and performing the basic dry eye tests, the necessary training and oral recommendations are given orally by the treatment group in the first, sixth and twelfth weeks according to the routine. The follow-up period of these patients is 3 months. .