An interventional study of pars plana vitrectomy in Macular Holes, sponsored by Fayoum University. Recruiting at 1 site in Egypt. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Fayoum University · Not applicable, Interventional, and Treatment
The goal of this prospective interventional study is to to compare the micro vascular and structural changes between surgery with and without ILM flap to repair macular hole.
The main questions it aims to answer are:
Participants will be:
Researchers will compare:
Group A: eyes treated without ILM flap Group B : eyes treated by ILM flap to see if there are differences regarding the micro vascular and structural changes in the macular area.
This study will include 28 eyes with idiopathic full thickness macular hole; they will be divided into two groups:
Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap
Data Collection :
History :
Clinical examination:
We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.
All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps:
Patients will be divided then into two groups:
Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done
SF 6 gas tamponade will be used
o Regular clinical assessment pre and at 1 and 6 months post-operative including:
Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
Macula thickness map for measurement of central retinal thickness, and photoreceptor inner segment/outer segment complex.
o Optical coherence tomography angiography of the macula at 1 and 6 months post-operative studying Superficial Capillary plexus, Deep Capillary plexus and Fovea avascular zone.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 28 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Fayoum University is the lead sponsor of 148 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Group A: Only wide ILM peeling up to the arcades well be done
Procedure: pars plana vitrectomy
Group B: ILM peeling with flap well be done
Procedure: pars plana vitrectomy
All eyes in this study will be subjected to pars plana vitrectomy procedure with these main steps: * 23 G trocar system will be used * Posterior vitreous detachment will be induced with the aid of triamcinolone acetate injection, and core vitrectomy will be done * Brilliant blue stain will be injected, and ILM forceps will be used for ILM peeling Patients will be divided then into two groups: Group A: Only wide ILM peeling up to the arcades well be done Group B: ILM peeling with flap well be done * Shaving of the vitreous base, and then fluid air exchange * SF 6 gas tamponade will be used
Also known as: PPV with ILM peeling
visual acuity
Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
Fovea avascular zone FAZ
Optical coherence tomography angiography used to measure FAZ area in mm2 (mm square)
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
central retinal thickness
Standard Optical coherence tomography of the macula using (SD-OCT) scans (512 A-scans, 20°×20°) to measure central retinal thickness in µm
Time frame: It will be measured preoperative and at 1 and 6 months post-operative
Plan to share: Yes — IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: data will become available before the end of 2024 and will be available for 1 year
Access criteria: it will be shared via E-mail
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