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IRCT20221230056988N1 IRCT 2023-03-14 Zahedan University of Medical Sciences treatment of infectious corneal ulcers resistant collagen cross-linking نام اختصاری CXL 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 2023-03-21 anticipated 30 Complete https://irct.ir/trial/68778 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 corneal ulcer. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after de-identification of subjects after the end of the study. When: The beginning of the access course from 1403 To whom: Researchers working in academic and scientific institutions will be available, or people who are also engaged in industry Conditions: 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. Where to obtain: To receive documents or data, send a request for the scope to Jamshidian.soru@gmail or call Dr. Jamshidian on phone number 00989056068899. How to obtain: After the request, whether by e-mail, SMS or phone, the information will be sent to the applicant within a maximum of one week Comments:
public Soroush Jamshidian
Al-Zahra Hospital, Motahari St., Motahari Blvd
Zahedan Iran (Islamic Republic of) 98167 37789 +98 54 3321 9915 jamshidian.sory@gmail.com Zahedan University of Medical Sciences scientific Soroush Jamshidian
Al-Zahra Hospital, Motahari St., Motahari Blvd
Zahedan Iran (Islamic Republic of) 98167 37789 +98 54 3321 9915 jamshidian.sory@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Every patient with infectious corneal ulcer resistant to routine treatment no limit no limit Both 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 H16.0 Corneal ulcer Treatment - Surgery Treatment - Drugs 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. 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. Average size and area of the wound. Timepoint: 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). 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). 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. 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. 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). 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. 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. 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). 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). Zahedan University of Medical Sciences Approved 2023-02-01 Ethics Committee of Zahedan University of Medical Sciences Al-Zahra Ophthalmology Hospital, Motahari Blvd, Khatam Square Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)