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

Determining the effectiveness of macular detachment surgery compared to internal limiting membrane peeling and flap surgery in the treatment of large macular hole

A clinical trial with a control group, parallel groups, double-blind, randomized based on the software of Dr. Saqai, will be conducted on 30 patients.

After obtaining the approval of the university ethics committee and obtaining a written consent form the patients, they enter the study. Before surgery, the best visual acuity of all patients is measured using the Snellen chart and calculated as LogMAR. Macula imaging is performed on all patients with the help of SD-OCT device. In MH imaging, its size is based on the minimum width of the macular hole that is measured by the device and recorded in the file. With the help of Dr. Saghaee's software, randomization is done and the surgeon is obliged to perform one of the two surgical methods based on randomization. 1. Combined MD and ILM peeling surgical method or 2. ILM peeling and inverted flap surgical method. Surgeries will performed in Feiz Hospital, Isfahan. After 3 months, the visual acuity, the rate of successful closure of the macular hole, will be compared between two groups.

Inclusion criteria: 1. Macular hole greater than 400 microns based on clinical examination and SD-OCT 2. Macular hole that the patient's symptoms have lasted for less than 2 years 3. Age over 50 years Exclusion criteria: History of any retinal surgery or retinal laser

1.combined MD and ILM peeling 2. Internal limiting membrane (ILM) peeling and inverted flap

The successful rate of anatomical closure of the macular hole and its effect on improving visual acuity in each of the two surgical methods

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

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.

Only part of the data related to the main outcome will be shared.

Access will start after the completion of the study and at the time of submitting the study to scientific journals.

Only researchers working in academic and scientific institutions

Data analysis will be possible only after obtaining permission from the authors and researchers.

Responsible author or scientific responsible for the study with the help of the email

After requesting the data, the researchers will work together to send the data information to the requester within one month.