An interventional study of Peeled ILM Reposition and ILM Peeling in Macular Holes, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-11.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
Macular hiatus (MH) refers to a tissue defect in the photoreceptor cell layer of the inner boundary membrane of the optic disc in the macular region. Among them, idiopathic macular hiatus (IMH) is more common in people over 60 years old and is a common eye disease. With the aging of society, the number of patients increases, and it severely damages the patients' vision and life quality. Previously, the conventional surgical approach for treating MH was vitrectomy combined with inner limiting membrane (ILM) peeling. Although the closure rate of MH is high, many damages to the morphology and function of the ILM peeled area have been found. Our team firstly report a novel technique of peeled ILM reposition. Compared to traditional ILM peeling, the novel technique peeled ILM reposition maintains the integrity of internal retina by "pull" back the ILM flap. The previous pilot clinical study suggests that the novel technique peeled ILM reposition surgical intervention can achieve better morphology and functional prognosis. However, there is currently a lack of larger sample size prospective randomized controlled studies to further clarify the clinical efficacy of this new surgical technique in treating IMH. This study aims to conduct a single center, prospective, and randomized controlled study, combined with previous work, to analyze the efficacy of this novel technique peeled ILM peeling in the treatment of IMH. We hypothesize that this novel technique can achieved better morphological and functional prognosis compared to traditional ILM peeling.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Peeled ILM Reposition
Procedure: Peeled ILM Reposition
ILM Peeling
Procedure: ILM Peeling
The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc) at a point away from the center of MH around one disc diameter in inferior quadrant of macular area. First, a horizontal ILM strip was peeled off with a width approximately 1.5 to 2.5 disc diameter. Then, the edge of the horizontal ILM strip was grasped and peeled from inferior to superior area continuously.Then the "ILM roll" was flattened back to peeled area assisted with approximately 1.0 mL of PFO (Perfluoron, Alcon Laboratories, Inc). The position of the fixed ILM flap was adjusted under PFO bubble using flute needle or forceps if required.
Also known as: ILM Flap reposition, ILM Flap covering
The ILM was stained using 0.1 mL of indocyanine green（ICG) for approximately 1minute after PPV. The ILM was grasped with end gripping forceps (Grieshaber Maxgrip 723.13; Alcon Laboratories Inc). The strand of ILM was peeled off radially from the foveal center to the vascular arcade. As a result, a round-shaped, 2.5-disk diameter to 3.5-disk diameter ILM-peeled area was created.
The change in the best corrected visual acuity (BCVA) from baseline to 6 months postoperatively
The change of BCVA from baseline to 6-month postoperatively
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The MH closure rate
The MH closure rate at 1-month postoperatively
Time frame: 1-month postoperatively
The range of inner retinal dimpling
The range of inner retinal dimpling was measured by OCT (RTVueXR Avanti; Optovue Inc, Fremont, CA)
Time frame: 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Postoperative retinal thickness
With the Thickness Map protocol of the OCT, the full retinal thickness (from ILM to retinal pigment epithelium), inner retinal thickness (from ILM to inner plexiform layer (IPL)), and outer retinal thickness (from IPL to retinal pigment epithelium) of the fovea, parafovea, and perifovea were recorded, respectively.
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
The fixation stability and sensitivity threshold
Measured by microperimetry (MAIA, CenterVue, Italy)
Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
mfERG P1 wave density amplitudes
Measured by multifocal electroretinogram (mfERG, Espion, Diagnosys LLC, Cambridge, United Kingdom)
Time frame: Pre-operatively, 3-month postoperatively, 6-month postoperatively,
M-score values
Metamorphopsia score (M-score) measurement was performed using the M-chart (Inami Co, Tokyo, Japan)
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
NEI-VFQ-25 questionnaire scores
The scores obtain from National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25 questionnaire)
Time frame: Pre-operatively, 1-month postoperatively, 3-month postoperatively, 6-month postoperatively,
Start is estimated for Apr 2024; primary completion for Jun 2026, 26 months later.
Of 45 non-industry interventional studies with no phase under Retinal Perforations, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 26 months is close to that.
Counting every sponsor, half of 45 studies reached it within 28 months; a quarter within 12 and three quarters within 31.
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