About this trial
The aim of this study is to compare the functional visual outcomes, anatomical closure rate and macular perfusion changes assessed by OCT and OCTA after surgical repair of macular hole using Tenon capsule graft versus ILM flap.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with idiopathic full-thickness macular hole
≥400 µm in horizontal diameter
Disqualifiers
Media opacity preventing adequate OCT/OCTA imaging
Other retinal vascular pathology as retinal vascular occlusion
Intraoperative complications
Signal noise ratio using OCTA <6\10
Trial design
Parallel
Treatments tested in this trial
vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]
Procedure/SurgeryProspective interventional study In all patients (Group A \& B), PPV will be performed using a 23-gauge, transconjunctival, microincision vitrectomy system. Diluted triamcinolone acetonide (40 mg/ml) will be used to visualize the vitreous. After core vitrectomy, posterior hyaloid detachment will be attempted with the vitrectomy cutter in the suction mode. Then, the ILM will be stained using 0.05% Brilliant Blue G (OCUBLUE PLUS, India). In Group A: tenon capsule graft will be attempted In Group B: free flap ILM peeling will be attempted SF6 gas will be used as tamponade in both groups More than one vitreoretinal surgeon will participate
Treatment groups
Trial outcomes
Primary outcomes
-Improvement in best corrected visual acuity (BCVA)
Improvement in BCVA measured by snellen E chart then transformation to Logarithm of the minimum angle of resolution (Log MAR)
Secondary outcomes
OCT
To assess healing and closure of hole by OCT OptovueInc, Fremont, CA (qualitative measure to assess if the hole is closed or not)
OCTA
superficial and deep capillary plexuses vessel density assessment by OCTA OptovueInc, Fremont, CA Sequential optical coherence tomography scans of a specific retinal region will be performed (central 3x3 Macular area Superficial, deep capillary plexus and choriocapillaris) and images will be processed in order to obtain motion contrast of erythrocytes within the vessel, thereby providing detailed imaging of the retinal capillary network. Capillary plexus density (CPD) of vessels in SCP, DCP and the size of the FAZ will be detected by OCTA en-face images. (Density is measured as percentage and thickness is measured by micrometer )
Sponsors and contacts
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