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IRCT20230226057539N1 IRCT 2023-05-20 Esfahan University of Medical Sciences Comparison of macular detachment surgery with ILM flap in retinal hole treatment Efficacy of Combined Internal Limiting Membrane Peeling and Macular Detachment surgery compared to Internal Limiting Membrane Peeling and Flap surgery in the treatment of Large macular hole in Isfahan city in 2023 2023-03-10 anticipated 30 Complete https://irct.ir/trial/69068 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the method of random allocation (randomization software of Dr. Soqaei), the patients were divided into two groups of 15 patients using the first surgical method, macular detachment (MD) or the second surgical method (Internal limiting membrane peeling with inverted flap). By ensuring the randomness of the treatment allocation, this software reduces the interactive effect of unknown factors and helps to examine the effect of the treatment more accurately. First, we enter the details of the plan include the number of groups (2 groups), the number of participants in each group (15 patients) and the type of the treatment (first or second surgical method) into the software. Then, using the random assignment option, numeric and random codes are given in the software, and the software randomly divides the patients into the first or second surgical groups, and the surgeon selects the surgical method using the obtained information. The software link is below: https://drive.google.com/file/d/0B9juB1UY-iu4TzZUVzZLOVZvM0k/view?usp=sharing, Blinding description: Patients will be informed about the two surgical procedures, but will not be informed about which surgical procedure will be used for them. Based on randomization with the help of the software, the surgeon will be obliged to perform the surgery for the patient based on the scientific principles of surgery without having the right to choose the surgical method for the patient. Finally, the examination will be continued by the researcher. N/A Macular hole. Intervention 1: Intervention group: combined Macular detachment and Internal Limiting Membrane peeling surgery 1. Deep vitrectomy is performed in the standard way with 3 ports.2. If the posterior hyaloid is not detached, posterior vitreous detachment is induced.3. ILM staining is done with the help of Brilliant Blue, and after 1 to 2 minutes, ILM peeling is done in the macular area in a circular manner in the vascular area.4. BSS injection is done through a 25/38 gauge cannula which is connected to a syringe containing BSS. These injections are done in 4 quadrants. The injection continues until the retinal bleb reaches the edge of the macular hole and can be seen exiting through the hole.5. Finally, air-fluid exchange is performed and internal tamponade is performed with the help of undiluted C3F8 gas in the amount of 0.4 ml inside the vitreous, and the patient is asked to sleep with face down position. Intervention 2: Control group: Internal Limiting Membrane peeling and inverted flap . 1. Deep vitrectomy is performed.2. ILM staining is performed, ILM peeling is performed in the macular area in a circular manner in the vascular area.3. The removed ILM is placed as a flap inside the macular hole.4. Finally, air-fluid exchange is performed and internal tamponade is performed with the help of undiluted C3F8 gas, and the patient is asked to lie with face down position. Yes - There is a plan to make this available What will be shared: Only part of the data related to the main outcome will be shared. When: Access will start after the completion of the study and at the time of submitting the study to scientific journals. To whom: Only researchers working in academic and scientific institutions Conditions: Data analysis will be possible only after obtaining permission from the authors and researchers. Where to obtain: Responsible author or scientific responsible for the study with the help of the email How to obtain: After requesting the data, the researchers will work together to send the data information to the requester within one month. Comments:
public Khodayar Golabchigilani
Feiz Hospital, Qods Sq, Esfahan
Esfahan Iran (Islamic Republic of) 4487481496 +98 31 3445 2031 khodayar82@gmail.com Esfahan University of Medical Sciences scientific Khodayar Golabchigilani
Feiz Hospital, Qods Sq, Isfahan City
Isfahan Iran (Islamic Republic of) 4487481496 +98 31 3447 6012 khodayar82@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Macular hole greater than 400 microns based on clinical examination and Spectral Domain Optical Coherence Tomography (SD-OCT) Macular hole (MH) in which the patient's symptoms have lasted less than 2 years Age above 50 years 50 years no limit Both Perform any retinal surgery or retinal laser Retinal holes due to secondary causes such as trauma Stage 1 or 2 macular holes Any disease other than Macular Hole (MH) that affects visual acuity except cataract If, for any reason, silicone oil is injected for tamponade during surgery H35.34 Macular cyst, hole, or pseudohole Treatment - Surgery Treatment - Surgery Intervention group: combined Macular detachment and Internal Limiting Membrane peeling surgery 1. Deep vitrectomy is performed in the standard way with 3 ports.2. If the posterior hyaloid is not detached, posterior vitreous detachment is induced.3. ILM staining is done with the help of Brilliant Blue, and after 1 to 2 minutes, ILM peeling is done in the macular area in a circular manner in the vascular area.4. BSS injection is done through a 25/38 gauge cannula which is connected to a syringe containing BSS. These injections are done in 4 quadrants. The injection continues until the retinal bleb reaches the edge of the macular hole and can be seen exiting through the hole.5. Finally, air-fluid exchange is performed and internal tamponade is performed with the help of undiluted C3F8 gas in the amount of 0.4 ml inside the vitreous, and the patient is asked to sleep with face down position. Control group: Internal Limiting Membrane peeling and inverted flap . 1. Deep vitrectomy is performed.2. ILM staining is performed, ILM peeling is performed in the macular area in a circular manner in the vascular area.3. The removed ILM is placed as a flap inside the macular hole.4. Finally, air-fluid exchange is performed and internal tamponade is performed with the help of undiluted C3F8 gas, and the patient is asked to lie with face down position. What is the success rate of closing the anatomical macular hole (MH) with macular detachment (MD) based on Spectral domain Optical Coherence Tomography (SD-OCT)?. Timepoint: Before surgery and 1 and 3 months after surgery. Method of measurement: The degree of success in the anatomical closure of the macular hole is expressed by SD-OCT analysis. What is the success rate of anatomical closure of MH with Inverted Flap Of Internal Limiting Membrane Peeling (i-ILM peeling) based on SD-OCT?. Timepoint: Before surgery and 1 and 3 months after surgery. Method of measurement: The degree of success in the anatomical closure of the macular hole is expressed by SD-OCT analysis. What is the level of visual acuity before and after MH surgery using the MD method with the help of Snellen chart and in the form of Logarithm of Minimum Angle of Resolution (LogMAR)?. Timepoint: Before surgery and 1 and 3 months after surgery. Method of measurement: Visual acuity is measured with the help of Snellen chart and is expressed based on Logarithm of Minimum Angle of Resolution (LogMAR). What is the level of visual acuity before and after MH surgery using the i-ILM peeling method with the help of Snellen chart and LogMAR?. Timepoint: Before surgery and 1 and 3 months after surgery. Method of measurement: Visual acuity is measured with the help of Snellen chart and is expressed based on Logarithm of Minimum Angle of Resolution (LogMAR). Esfahan University of Medical Sciences Approved 2023-01-23 Isafahan University of Medical Sciences MUI, Hezarjarib St Esfahan Isfehan Iran (Islamic Republic of)