Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2025-12-17 @ 2:45 AM
Study NCT ID:
NCT06233500
Status:
None
Last Update Posted:
2024-01-31 00:00:00
First Post:
2024-01-22 00:00:00
Brief Title:
Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
Sponsor:
Fayoum University
Organization:
Fayoum University
Study Overview
Official Title:
Macular Micro Vascular Changes Following Macular Hole Repair : Optical Coherence Tomography Angiography Study
Status:
None
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
* 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.
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.
Detailed Description:
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
Sample size 28 eyes based on ELM recovery rate in ILM flap 70 versus 214 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 2020 with the following protocol
Macula thickness map for measurement of central retinal thickness and photoreceptor inner segmentouter 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
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 214 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 2020 with the following protocol
Macula thickness map for measurement of central retinal thickness and photoreceptor inner segmentouter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None