Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441656
Status:
COMPLETED
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
The Flip and Fix Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
The Flip and Fix Internal Limiting Flap Technique Versus the Classic Temporal Flap for Macular Hole Repair
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Flip and Fix
Brief Summary:
Purpose To describe a novel technique of MH repair and compare it to the perfluorocarbon liquid PFCL assisted temporal ILM flap technique
Methods Twenty-two eyes of 22 patients with MH were randomized on 11 basis into two groups Group A cases were treated using the Flip and Fix technique in which the single-layer ILM flap was flipped flattened over the macula using PFCL and fixed in place using 2 drops of autologous non-heparinized blood over the superonasal and the inferonasal edges of the flap away from the MH center Group B patients had the classic temporal ILM flap technique without using the PFCL or autologous blood All patients were followed up for a period of 6 months after the surgery
Results No significant difference was observed in initial and final visual acuities between Groups A and B Intraoperative flap displacement and did not occur in Group A and occurred in 2 eyes in Group B 182 one of them showed failed MH closure and required reoperation These 2 cases had a final W shape MH closure and a worse final vision than the remaining cases which had either U shape or V shape final MH closure
Conclusions The study results show that the Flip and Fix technique is as effective as the PFCL-assisted temporal ILM flap technique and is associated with less ILM flap displacement risk for the repair of macular holes
Methods Twenty-two eyes of 22 patients with MH were randomized on 11 basis into two groups Group A cases were treated using the Flip and Fix technique in which the single-layer ILM flap was flipped flattened over the macula using PFCL and fixed in place using 2 drops of autologous non-heparinized blood over the superonasal and the inferonasal edges of the flap away from the MH center Group B patients had the classic temporal ILM flap technique without using the PFCL or autologous blood All patients were followed up for a period of 6 months after the surgery
Results No significant difference was observed in initial and final visual acuities between Groups A and B Intraoperative flap displacement and did not occur in Group A and occurred in 2 eyes in Group B 182 one of them showed failed MH closure and required reoperation These 2 cases had a final W shape MH closure and a worse final vision than the remaining cases which had either U shape or V shape final MH closure
Conclusions The study results show that the Flip and Fix technique is as effective as the PFCL-assisted temporal ILM flap technique and is associated with less ILM flap displacement risk for the repair of macular holes
Detailed Description:
We conducted a prospective randomized comparative interventional study in which we enrolled patients older than 50 years with idiopathic macular holes who presented to Removed in the blinded version of manuscript in the period between February 2021 and February 2022 Patients with previous macular surgeries and those with any other significant macular pathologies eg diabetic macular oedema myopic maculopathy choroidal neovascular membrane or macula-off retinal detachment were excluded
The study protocol was reviewed and approved by the Ethics Committee of Removed in the blinded version of manuscript All patients signed an informed consent after explaining the procedures The study was conducted in accordance with the tenets of the Declaration of Helsinki
For all the patients a retina consultant I A masked to the procedure that will be done for the patient conducted a comprehensive ophthalmic examination including best-corrected visual acuity BCVA measured using the Snellens chart and then converted to the LogMAR for the statistical analysis slit-lamp examination and fundus examination
All the patients had a pre-operative macular OCT scan done The scans were assessed by the masked retina consultant I A to confirm the diagnosis and to measure the minimum MH diameter
The included patients were randomized by a research nurse on a 11 basis using the closed envelope technique to have either the new Flip and fix technique Group A or the PFCL assisted temporal inverted ILM flap technique Group B
All the surgeries were done under general anaesthesia by a single surgeon M A using a wide-angle viewing non-contact system Resight Carl Zeiss Meditec AG Jena Germany and 23 Gauge Alcon Constellation vitrectomy machine Alcon Laboratories Fort Worth TX to complete the core vitrectomy and induction of the posterior vitreous detachment if not already detached this was followed by an injection the Brilliant Blue G Tissueblue 0025 DORC Zuidland The Netherland to stain the ILM
In both groups a single-layer ILM temporal flap of approximately 2 times the size of the optic disc was fashioned using an ILM forceps temporal to the macula The nasal edge of the flap was not detached from the temporal MH edge The flap was reflected nasally to cover the MH In the Flip and Fix technique group the flipped ILM flap was secured in place and flattened over the macular surface using a 15 cc bubble of PFCL Arcaline Arcadophtha Toulouse France injected over the flipped ILM flap Then fluid air exchange with removal of the PFCL bubble was done followed by fixing the ILM flap over the macular surface using two drops of autologous non-heparinized blood -collected by the attending nurse or anaesthesiologist from one of the veins on the dorsum of the hand- one dropped over the superior-nasal and another at the inferior-nasal edges of the ILM flap away from the MH center On the other hand in the classic temporal ILM flap group PFCL and blood were not used to fix the ILM flap Videos demonstrating the technique are provided as supplemental files 1 and 2
In both groups at the conclusion of the surgery the air was exchanged for a non-expansile concentration 20 of sulphur hexafluoride gas SF6 and the patient was asked to maintain a face -down position for 5 days postoperatively The surgical steps of the flap and fix technique are summarized in Figure 1
For all the cases intraoperative ILM flap displacement defined as a significant displacement of the inverted ILM flap after its initial positioning over the MH that necessitated readjustment was reported by the operating surgeon
All the patients were examined postoperatively at 1 3 and 6 months by a retina consultant masked to the used surgical procedure I A The best corrected visual acuity slit-lamp examination fundus examination and macular OCT scanning were done in each postoperative visit
According to the cross-sectional morphology on the postoperative macular OCT scan foveal contour was classified into one of the following categories U-shape V-shape and W-shape irregular The presence of a thin hyperreflective band of tissue extending on both sides of the previous MH Flap between the inner surface of the retina was assessed and considered a membranous ie flap closure
The data about the pre-operative MH base size minimum MH diameter BCVA post-operative closure rate BCVA and the pattern of the MH closure was collected
The study protocol was reviewed and approved by the Ethics Committee of Removed in the blinded version of manuscript All patients signed an informed consent after explaining the procedures The study was conducted in accordance with the tenets of the Declaration of Helsinki
For all the patients a retina consultant I A masked to the procedure that will be done for the patient conducted a comprehensive ophthalmic examination including best-corrected visual acuity BCVA measured using the Snellens chart and then converted to the LogMAR for the statistical analysis slit-lamp examination and fundus examination
All the patients had a pre-operative macular OCT scan done The scans were assessed by the masked retina consultant I A to confirm the diagnosis and to measure the minimum MH diameter
The included patients were randomized by a research nurse on a 11 basis using the closed envelope technique to have either the new Flip and fix technique Group A or the PFCL assisted temporal inverted ILM flap technique Group B
All the surgeries were done under general anaesthesia by a single surgeon M A using a wide-angle viewing non-contact system Resight Carl Zeiss Meditec AG Jena Germany and 23 Gauge Alcon Constellation vitrectomy machine Alcon Laboratories Fort Worth TX to complete the core vitrectomy and induction of the posterior vitreous detachment if not already detached this was followed by an injection the Brilliant Blue G Tissueblue 0025 DORC Zuidland The Netherland to stain the ILM
In both groups a single-layer ILM temporal flap of approximately 2 times the size of the optic disc was fashioned using an ILM forceps temporal to the macula The nasal edge of the flap was not detached from the temporal MH edge The flap was reflected nasally to cover the MH In the Flip and Fix technique group the flipped ILM flap was secured in place and flattened over the macular surface using a 15 cc bubble of PFCL Arcaline Arcadophtha Toulouse France injected over the flipped ILM flap Then fluid air exchange with removal of the PFCL bubble was done followed by fixing the ILM flap over the macular surface using two drops of autologous non-heparinized blood -collected by the attending nurse or anaesthesiologist from one of the veins on the dorsum of the hand- one dropped over the superior-nasal and another at the inferior-nasal edges of the ILM flap away from the MH center On the other hand in the classic temporal ILM flap group PFCL and blood were not used to fix the ILM flap Videos demonstrating the technique are provided as supplemental files 1 and 2
In both groups at the conclusion of the surgery the air was exchanged for a non-expansile concentration 20 of sulphur hexafluoride gas SF6 and the patient was asked to maintain a face -down position for 5 days postoperatively The surgical steps of the flap and fix technique are summarized in Figure 1
For all the cases intraoperative ILM flap displacement defined as a significant displacement of the inverted ILM flap after its initial positioning over the MH that necessitated readjustment was reported by the operating surgeon
All the patients were examined postoperatively at 1 3 and 6 months by a retina consultant masked to the used surgical procedure I A The best corrected visual acuity slit-lamp examination fundus examination and macular OCT scanning were done in each postoperative visit
According to the cross-sectional morphology on the postoperative macular OCT scan foveal contour was classified into one of the following categories U-shape V-shape and W-shape irregular The presence of a thin hyperreflective band of tissue extending on both sides of the previous MH Flap between the inner surface of the retina was assessed and considered a membranous ie flap closure
The data about the pre-operative MH base size minimum MH diameter BCVA post-operative closure rate BCVA and the pattern of the MH closure was collected
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