Comparison of two treatments corneal collagen cross-linking(CXL) and povidone-iodine 1% solution in the treatment of infectious corneal ulcers resistant to conventional drug treatment
Comparison of two treatments collagen cross-linking and povidone-iodine 1% solution in the treatment of infectious corneal ulcers resistant to conventional drug treatment
After the examination by the cornea specialist and the confirmation of the diagnosis of corneal ulcer by culture and smear in the patients referred to Zahra Zahedan Ophthalmology Hospital, the patients will undergo routine and standard treatment for 3 days. In case there are no symptoms of improvement or the worsening process is stopped, the patients will be entered into the study in a block-random way in two groups in a one-sided blind manner after informed consent. The first group with corneal collagen cross-linking (CXL) and the second group with 1% betadine.
Participants/Inclusion and exclusion criteria
Every patient with infectious corneal ulcer resistant to routine treatment؛
1- Leaving the study during research for any reason
2- Unwillingness to participate in the study
3- Absence of a regular clinical file
4- History or presence of previous eye disease
5- Systemic diseases that have been proven to be effective in the treatment process, such as diabetes, autoimmune diseases, etc.
6- Inability to follow up the patient
Intervention groups
In the first group, routine treatment is continued along with corneal collagen cross-linking (CXL) for the patient. The most accepted protocol is based on the original Dresden protocol.
Also, the second group is related to treatment with betadine 1%. This treatment method will be local, in the loading phase, every 15 minutes for one hour and then one drop every three hours. Also, routine medical treatment is continued along with 1% betadine treatment.
Main outcome variables
Comparison of two treatment methods
The effect of each method separately on the corneal wound
General information
Reason for update
Acronym
collagen cross-linking نام اختصاری CXL
IRCT registration information
IRCT registration number:IRCT20221230056988N1
Registration date:2023-03-14, 1401/12/23
Registration timing:prospective
Last update:2023-03-14, 1401/12/23
Update count:0
Registration date
2023-03-14, 1401/12/23
Registrant information
Name
Soroush Jamshidian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4264 5370
Email address
jamshidian.sory@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-21, 1402/01/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two treatments corneal collagen cross-linking(CXL) and povidone-iodine 1% solution in the treatment of infectious corneal ulcers resistant to conventional drug treatment
Public title
treatment of infectious corneal ulcers resistant
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Every patient with infectious corneal ulcer resistant to routine treatment
Exclusion criteria:
Withdrawal from the study during the research for any reason
Unwillingness to participate in the study
Absence of a regular clinical record
History or presence of previous eye disease
Systemic diseases have been proven to be effective in the treatment process, such as diabetes, autoimmune diseases, etc.
Impossibility of patient follow-up
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of patients to two groups is done by permuted block stratified randomization method. In this way, first, eligible referring patients are classified according to age and gender in the order of arrival. Then they are assigned to the desired group based on blocks of 4 (consisting of two groups A and B and two repetitions for each) randomly selected from among all the possible states of permutations. These blocks were created using statistical software R version 4.0.2
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the study for sampling, random allocation of eyes to two intervention groups in such a way that only the patients do not know which group they are in, and the implementation of the intervention and data collection before and after the study by the cornea specialist and the main researcher. is done Thus, patients are blinded in this study. They are unaware of grouping. The groups are provided as A and B.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Measurement of the average size and area of the wound before treatment, one day, three days, one week, 14 days, 21 days and 28 days after treatment.
Method of measurement
slit-lamp device in two axes (the largest size and the smallest size)
2
Description
Frequency of stromal infiltration in corneal ulcer
Timepoint
Frequency of stromal infiltration before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
slit-lamp device (from +4 to +1)
3
Description
Frequency of blunting of wound edges
Timepoint
Frequency of blunting of wound edges before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
Slit-lamp device +1 to +4
4
Description
Recovery time
Timepoint
Recovery time before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
From the patient's file
5
Description
Frequency of wound penetration
Timepoint
Frequency of wound penetration before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
slit-lamp device (grade one: limited to the anterior 1/3 of the cornea, grade two: limited to the anterior 2/3 of the cornea, grade three: involvement of the entire thickness of the cornea)
Secondary outcomes
1
Description
Frequency of pain
Timepoint
Frequency of pain before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
Questionnaire yes or no
2
Description
Frequency of visual acuity
Timepoint
Frequency of visual acuity before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
With questions and pen light: non-understanding of light (NLP), understanding of light (LP), understanding of hand movements (HM), counting fingers (CF) in meters
3
Description
Vascularization frequency
Timepoint
Frequency of vascularization before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
slit-lamp device (yes/no)
4
Description
Average hypopyon size
Timepoint
Average hypopyon size before treatment, one day, three days, one week, 14 days, 21 days, 28 days after treatment
Method of measurement
slit-lamp device (mm)
Intervention groups
1
Description
Intervention group: In the first group, the continuation of the routine treatment along with cross-linking (as described in the text) by CXL device (Avedro model from Tovana Radio Equipment Company) is performed for the patient:The most accepted protocol based on the original Dresden protocol is the epithelial harvesting approach described by Wollensak et al. in 2003. This approach includes 0.1% riboflavin along with UVA radiation (370nm; @3mw/cm2) which injects 4.5 J/cm2 into the cornea. The steps of the surgical protocol are as follows:1- The patient is covered with a cloth under sterile conditions and the cornea is numbed locally with 2-3 drops of 0.5% proparacaine or 0.5% tetracaine.2- The orbital areas are cleaned with 10% betadine and a speculum is placed.3- The corneal epithelium is removed in the central 7-9 mm, which includes the entire surface of the wound.4- The thickness of the cornea is measured with an ultrasound thickness meter to ensure that it is 400 microns thick.5- 0.1% iso-osmolar riboflavin in 20% dextran solution is dripped on the surface of the cornea every 2 to 3 minutes for 30 minutes.6- The patient is examined behind a slit lamp with blue light to ensure the complete penetration of riboflavin into the cornea (the examination of riboflavin is done in the anterior chamber with the presence of yellow dyes).7- Corneal pachymetry is measured again before UVA radiation.8- If there is no danger to continue the process, a spongy ring is placed around the limbus of the cornea with preservation of limbal stem cells.9- UVA light is focused directly on the area that lacks epithelium, to activate the stroma rich in riboflavin.10- The light is illuminated for 30 minutes by continuing to pour riboflavin every three minutes.11- Alternatively, a balanced saline solution and an anesthetic drop is poured on the surface of the cornea to prevent drying and continued anesthesia.12- Corneal pachymetry is performed 20, 10, and 30 minutes after riboflavin drop to make sure that the thickness of the stroma remains more than 400 microns. If the pachymeter shows below 400 microns, the hypotonic riboflavin drop is used instead of the usual isotonic drop.13- After completing the treatment with UVA, a broad-spectrum antibiotic such as moxifloxacin is poured.14- At the end, after washing the eyes, the bandaged contact lens is used and the previous treatments are continued, and the patient remains hospitalized until the corneal wound is completely healed and is examined daily.
Category
Treatment - Surgery
2
Description
Intervention group: The second group is related to treatment with betadine 1%. The method of making Betadine 1% (10 mg/ml) from the composition (dissolution) of Povidone Iodine 10% solution (manufactured by Aburihan and Iran Naj companies, iodine which is not bactericidal and Povidone which is not disinfectant and pre-operative disinfectant) Preoperative Antiseptic (considered) is obtained with Balanced Salt Solution. This treatment method will be local, in the loading phase, one drop is used every 15 minutes for one hour and then every three hours. Also, routine medical treatment is continued along with 1% betadine treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Ophthalmology Hospital
Full name of responsible person
Soroush Jamshidian
Street address
Khatam Square, Shahid Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3321 9915
Email
jamshidian.sory@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Validad
Street address
Medical Sciences Campus, Dr. Hasabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
it@zaums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Soroush Jamshidian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Al-Zahra Hospital, Motahari St., Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3321 9915
Email
jamshidian.sory@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Soroush Jamshidian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Al-Zahra Hospital, Motahari St., Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3321 9915
Email
jamshidian.sory@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Soroush Jamshidian
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Al-Zahra Hospital, Motahari St., Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167 37789
Phone
+98 54 3321 9915
Email
jamshidian.sory@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can potentially be shared after de-identification of subjects after the end of the study.
When the data will become available and for how long
The beginning of the access course from 1403
To whom data/document is available
Researchers working in academic and scientific institutions will be available, or people who are also engaged in industry
Under which criteria data/document could be used
All researchers and people who need data to carry out diagnostic and therapeutic measures and conduct further research related to corneal ulcers, data and documentation are provided to them depending on the conditions and request of the researcher, and the use and analysis of data is allowed without any restrictions. is.
From where data/document is obtainable
To receive documents or data, send a request for the scope to Jamshidian.soru@gmail or call Dr. Jamshidian on phone number 00989056068899.
What processes are involved for a request to access data/document
After the request, whether by e-mail, SMS or phone, the information will be sent to the applicant within a maximum of one week