Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
NCT ID: NCT06233500
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
28 participants
INTERVENTIONAL
2021-12-01
2024-03-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main questions it aims to answer are:
* What are the macular micro vascular and structural changes pre and post repair of idiopathic full thickness macular hole and what is the correlation between these changes and visual recovery.
* Is there are any prognostic values of the micro vascular status of the macula could be assessed preoperatively.
* What are the differences regarding these micro vascular and structural changes between repair with and without ILM flap.
Participants will be:
* Subjected to pars plana vitrectomy to repair macular hole.
* Examined by optical coherence tomography angiography pre and post operative
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
NCT01229657
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
NCT01306487
Macular Hole Reopening
NCT00927628
Effects of Macular Buckle Versus Vitrectomy on Macular Hole and Macular Detachment in Highly Myopic Eyes
NCT03433547
Optical Coherence Tomography Angiography Characteristics of Patients With Surgically Closed Full-thickness Idiopathic Macular Holes < 600 μm With Air Versus 10% SF6 Tamponade
NCT05223205
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Group A: 14 eyes will be treated without ILM flap Group B : 14 eyes will be treated by ILM flap
* Sample size: 28 eyes. (based on ELM recovery rate in ILM flap 70% versus 21.4% with inverted flap (Iwasaki et al., 2019), and at power of study 80% and confidence level 95%, sample size is calculated using openEpi software to be 14 eyes in each group
* Study setting: Ophthalmology Department, Fayoum University and the Research Institute of Ophthalmology
* Data Collection :
* History :
1. Demographic data ( age , gender )
2. General medical history ( DM, HTN )
3. Symptom duration
4. Previous ocular history
* Clinical examination:
1. Best corrected visual acuity using snellen chart (converted to log MAR for statiscal analysis).
2. Slit lamp biomicroscopy for anterior segment examination.
3. Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
4. Axial length measurement
* Optical Coherence Tomography:
We use SD- OCT and OCTA for pre and post-operative evaluation of retinal layers microstructure and vasculature.
* Surgical Procedure
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
• Study procedures:
o Regular clinical assessment pre and at 1 and 6 months post-operative including:
* Best corrected visual acuity measurement using Snellen chart with conversion to log. MAR notation for statistical analysis
* Posterior segment examination using binocular indirect ophthalmoscope and indirect slit lamp bio microscopy (+90 volk lens for detailed evaluation of macula)
* Standard Optical coherence tomography of the macula at 1 and 6 months post-operative using (SD-OCT) scans (512 A-scans, 20°×20°) with the following protocol:
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Group A: 16 eyes will be treated with only wide internal limiting membrane (ILM) peeling up to the arcades without ILM flap Group B : 16 eyes will be treated by ILM peeling with ILM flap.
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A: eyes will be treated without ILM flap
Group A: Only wide ILM peeling up to the arcades well be done
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
Group B : eyes will be treated by ILM flap
Group B: ILM peeling with flap well be done
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* High myopia with axial length ≥ 26 mm.
* Uncertain symptom duration or ≥ 6 month .
* History of same eye trauma
* Poor image quality.
* Patients with diabetic retinopathy or other retinal diseases, e.g. ischemic, inflammatory.
* Any patient with significant cataract which needs combined phaco-vitrectomy.
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Research Institute of Ophthalmology, Egypt
OTHER
Fayoum University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Hussein
Dr.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Islam Mohalhal, MD
Role: STUDY_DIRECTOR
Research Institute of Ophthalmology, Egypt
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
research institute of ophthalmology, Egypt
Giza, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Demirel S, Degirmenci MFK, Bilici S, Yanik O, Batioglu F, Ozmert E, Alp N. The Recovery of Microvascular Status Evaluated by Optical Coherence Tomography Angiography in Patients after Successful Macular Hole Surgery. Ophthalmic Res. 2018;59(1):53-57. doi: 10.1159/000484092. Epub 2017 Nov 29.
Kelly NE, Wendel RT. Vitreous surgery for idiopathic macular holes. Results of a pilot study. Arch Ophthalmol. 1991 May;109(5):654-9. doi: 10.1001/archopht.1991.01080050068031.
Lai MM, Williams GA. Anatomical and visual outcomes of idiopathic macular hole surgery with internal limiting membrane removal using low-concentration indocyanine green. Retina. 2007 Apr-May;27(4):477-82. doi: 10.1097/01.iae.0000247166.11120.21.
Casini G, Mura M, Figus M, Loiudice P, Peiretti E, De Cilla S, Fuentes T, Nasini F. INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR MACULAR HOLE SURGERY WITHOUT EXTRA MANIPULATION OF THE FLAP. Retina. 2017 Nov;37(11):2138-2144. doi: 10.1097/IAE.0000000000001470.
Yun C, Ahn J, Kim M, Kim JT, Hwang SY, Kim SW, Oh J. Characteristics of retinal vessels in surgically closed macular hole: an optical coherence tomography angiography study. Graefes Arch Clin Exp Ophthalmol. 2017 Oct;255(10):1923-1934. doi: 10.1007/s00417-017-3742-6. Epub 2017 Jul 25.
Woon WH, Greig D, Savage MD, Wilson MC, Grant CA, Mokete B, Bishop F. Movement of the inner retina complex during the development of primary full-thickness macular holes: implications for hypotheses of pathogenesis. Graefes Arch Clin Exp Ophthalmol. 2015 Dec;253(12):2103-9. doi: 10.1007/s00417-015-2951-0. Epub 2015 Feb 13.
Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.
Spaide RF, Klancnik JM Jr, Cooney MJ. Retinal vascular layers imaged by fluorescein angiography and optical coherence tomography angiography. JAMA Ophthalmol. 2015 Jan;133(1):45-50. doi: 10.1001/jamaophthalmol.2014.3616.
Lupidi M, Coscas F, Cagini C, Fiore T, Spaccini E, Fruttini D, Coscas G. Automated Quantitative Analysis of Retinal Microvasculature in Normal Eyes on Optical Coherence Tomography Angiography. Am J Ophthalmol. 2016 Sep;169:9-23. doi: 10.1016/j.ajo.2016.06.008. Epub 2016 Jun 11.
Samara WA, Say EA, Khoo CT, Higgins TP, Magrath G, Ferenczy S, Shields CL. CORRELATION OF FOVEAL AVASCULAR ZONE SIZE WITH FOVEAL MORPHOLOGY IN NORMAL EYES USING OPTICAL COHERENCE TOMOGRAPHY ANGIOGRAPHY. Retina. 2015 Nov;35(11):2188-95. doi: 10.1097/IAE.0000000000000847.
Kim YJ, Jo J, Lee JY, Yoon YH, Kim JG. Macular capillary plexuses after macular hole surgery: an optical coherence tomography angiography study. Br J Ophthalmol. 2018 Jul;102(7):966-970. doi: 10.1136/bjophthalmol-2017-311132. Epub 2017 Oct 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FayoumU_28
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.